TriangleNCT03511664 · CITED IN SOURCE DOCUMENTS
Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2025-01-13
The primary objective of this study was to compare the two alternate primary endpoints of radiographic progression-free survival (rPFS) and overall survival (OS) in patients with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who received 177Lu-PSMA-617 in addition to best supportive/best standard of care (BSC/BSoC) versus patients treated with best supportive/best standard of care alone.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Radiographic Progression-free Survival (rPFS)
Overall Survival (OS)
Number of Participants With Randomized/Study Treatment-emergent Adverse Events (TEAE)
Overall Response Rate (ORR)
Disease Control Rate (DCR)
Duration of Response (DOR)
Time to First Symptomatic Skeletal Event (SSE)
Progression-free Survival (PFS)
Best Percentage Change From Baseline in Prostate-specific Antigen (PSA) Level
Percentage of Participants Achieving Prostate-specific Antigen (PSA) Response
Prostate-specific Antigen 80 (PSA80) Response
Duration of PSA Response
Best Percentage Change From Baseline in Alkaline Phosphatase (ALP) Level
Best Percentage Change From Baseline in Lactate Dehydrogenase (LDH) Level
Time to Worsening in BPI-SF Pain Intensity Scale
Time to Improvement After Worsening in BPI-SF Pain Intensity Scale
Time to Worsening in BPI-SF Pain Interference Scale
Time to Improvement After Worsening in BPI-SF Pain Interference Scale
Time to Worsening in BPI-SF Worst Pain Intensity Scale (Time to Disease Related Pain)
Change From Baseline in BPI-SF (Brief-Pain Inventory - Short Form) Pain Intensity Scale
Change From Baseline in BPI-SF (Brief-Pain Inventory - Short Form) Pain Interference Scale
Time to Worsening in FACT-P Total Score
Change From Baseline in FACT-P (Functional Assessment of Cancer Therapy - Prostate) Total Score
Time to Worsening in EQ-5D-5L Utility Score
Change From Baseline in the European Quality of Life (EuroQol) - 5 Domain 5 Level Scale (EQ-5D-5L) Utility Score
Change From Baseline in the European Quality of Life (EuroQol) - 5 Domain 5 Level Scale (EQ-5D-5L) EQ-VAS
Number of Participants Hospitalized as In-patient
Duration of Time in Hospital Following 177Lu-PSMA-617 Administration
Concomitant Drug Use for Health Economics Analysis
Therapeutic Interventions for Health Economics Analysis
All Collected Deaths
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: 1. Patients must have the ability to understand and sign an approved informed consent form (ICF). 2. Patients must have the ability to understand and comply with all protocol requirements. 3. Patients must be \>= 18 years of age. 4. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 5. Patients must have a life expectancy \>6 months. 6. Patients must have histological, pathological, and/or cytological confirmation of prostate cancer. 7. Patients must be 68Ga-PSMA-11 Positron Emission Tomography (PET)/Computed Tomography (CT) scan positive, and eligible as determined by the sponsor's central reader. 8. Patients must have a castrate level of serum/plasma testosterone (\<50 ng/dL or \<1.7 nmol/L). 9. Patients must have received at least one NAAD (such as enzalutamide and/or abiraterone). 10. Patients must have been previously treated with at least 1, but no more than 2 previous taxane regimens. A taxane regimen is defined as a minimum exposure of 2 cycles of a taxane. If a patient has received only 1 taxane regimen, the patient is eligible if: a. The patient's physician deems him unsuitable to receive a second taxane regimen (e.g. frailty assessed by geriatric or health status evaluation, intolerance, etc.). 11. Patients must have progressive mCRPC. Documented progressive mCRPC will be based on at least 1 of the following criteria: 1. Serum/plasma PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal start value is 2.0 ng/mL. 2. Soft-tissue progression defined as an increase \>= 20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of one or more new lesions. 3. Progression of bone disease: evaluable disease or new bone lesions(s) by bone scan (2+2 PCWG3 criteria, Scher et al 2016). 12. Patients must have \>= 1 metastatic lesion that is present on baseline CT, MRI, or bone scan imaging obtained =\< 28 days prior to beginning study therapy. 13. Patients must have recovered to =\< Grade 2 from all clinically significant toxicities related to prior therapies (i.e. prior chemotherapy, radiation, immunotherapy, etc.). 14. Patients must have adequate organ function: a. Bone marrow reserve: * White blood cell (WBC) count \>= 2.5 x 10\^9/L (2.5 x 10\^9/L is equivalent to 2.5 x 10\^3/μL and 2.5 x K/μL and 2.5 x 10\^3/cumm and 2500/μL) OR absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L (1.5 x 10\^9/L is equivalent to 1.5 x 10\^3/μL and 1.5 x K/μL and 1.5 x 10\^3/cumm and 1500/μL) * Platelets \>= 100 x 10\^9/L (100 x 10\^9/L is equivalent to 100 x 10\^3/μL and 100 x K/μL and 100 x 10\^3/cumm and 100,000/μL) * Hemoglobin \>= 9 g/dL (9 g/dL is equivalent to 90 g/L and 5.59 mmol/L) b. Hepatic: * Total bilirubin =\< 1.5 x the institutional upper limit of normal (ULN). For patients with known Gilbert's Syndrome =\< 3 x ULN is permitted * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =\< 3.0 x ULN OR =\< 5.0 x ULN for patients with liver metastases c. Renal: * Serum/plasma creatinine =\< 1.5 x ULN or creatinine clearance \>= 50 mL/min 15. Albumin \>3.0 g/dL (3.0 g/dL is equivalent to 30 g/L) \[Inclusion #16 has been removed\] 17\. HIV-infected patients who are healthy and have a low risk of AIDS-related outcomes are included in this trial. 18\. For patients who have partners of childbearing potential: Partner and/or patient must use a method of birth control with adequate barrier protection, deemed acceptable by the principle investigator during the study and for 6 months after last study drug administration. 19\. The best standard of care/ best supportive care options planned for this patient: 1. Are allowed by the protocol 2. Have been agreed to by the treating investigator and patient 3. Allow for the management of the patient without 177Lu-PSMA-617 Exclusion Criteria: 1. Previous treatment with any of the following within 6 months of randomization: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation. Previous PSMA-targeted radioligand therapy is not allowed. 2. Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy \[including monoclonal antibodies\]) within 28 days prior to day of randomization. 3. Any investigational agents within 28 days prior to day of randomization. 4. Known hypersensitivity to the components of the study therapy or its analogs. 5. Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy. 6. Transfusion for the sole purpose of making a subject eligible for study inclusion. 7. Patients with a history of Central Nervous System (CNS) metastases must have received therapy (surgery, radiotherapy, gamma knife) and be neurologically stable, asymptomatic, and not receiving corticosteroids for the purposes of maintaining neurologic integrity. Patients with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired. For patients with parenchymal CNS metastasis (or a history of CNS metastasis), baseline and subsequent radiological imaging must include evaluation of the brain (MRI preferred or CT with contrast). 8. A superscan as seen in the baseline bone scan. 9. Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression. 10. Concurrent serious (as determined by the Principal Investigator) medical conditions, including, but not limited to, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, known active hepatitis B or C, or other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation. 11. Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, patients with a prior history of malignancy that has been adequately treated and who have been disease free for more than 3 years are eligible, as are patients with adequately treated non-melanoma skin cancer, superficial bladder cancer.
- gender Based
- true
- gender Description
- Prostate cancer
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- MALE
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Patients randomized to receive the investigational product received 7.4 GBq (+/- 10%) 177Lu-PSMA-617 intravenously every 6 weeks (+/- 1 week) for a maximum of 6 cycles. Best supportive/best standard of care (BS/BSOC) might be used
- intervention Names
- Drug: 177Lu-PSMA-617
- Other: Best supportive/best standard of care
- label
- 177Lu-PSMA-617 plus best supportive/best standard of care (BS/BSOC)
- type
- EXPERIMENTAL
- description
- Patients randomized to this arm received best supportive/best standard of care (BS/BSOC) as determined by the investigator
- intervention Names
- Other: Best supportive/best standard of care
- label
- Best supportive/best standard of care (BS/BSOC) alone
- type
- OTHER
- interventions
- arm Group Labels
- 177Lu-PSMA-617 plus best supportive/best standard of care (BS/BSOC)
- description
- Administered intravenously once every 6 weeks (1 cycle) for a maximum of 6 cycles. After 4 cycles, patients were assessed for (1) evidence of response, (2) residual disease, and (3) tolerance to 177Lu-PSMA-617. If all 3 assessments were met the patient might received an additional 2 cycles of 177Lu-PSMA-617.
- name
- 177Lu-PSMA-617
- type
- DRUG
- arm Group Labels
- 177Lu-PSMA-617 plus best supportive/best standard of care (BS/BSOC)
- Best supportive/best standard of care (BS/BSOC) alone
- description
- Best supportive/best standard of care as defined by the local investigator
- name
- Best supportive/best standard of care
- type
- OTHER
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- intervention Model Description
- Participants in the Main Study were randomized in a 2:1 ratio to receive either 177Lu-PSMA-617 plus BSC/BSoC or BSC/BSoC only. The sub-study was conducted in a non-randomized cohort (AAA617+ BSC/BSoC)
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 861
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Radiographic progression-free survival (rPFS) was defined as the time (in months) from the date of randomization to the date of radiographic disease progression based on the central review assessment per the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria or death due to any cause. Patients who were alive without radiographic progression at the analysis data cut-off were censored for rPFS at the time of their last evaluable radiographic assessment. Date of censoring for rPFS: 1) The censoring date was the date when the last evaluable radiographic assessment (CT/MRI/bone scan) determined a lack of progression; 2) If there were no evaluable assessments, censoring occurred at the date of randomization; 3) Patients who had 2 or more consecutive missed tumor assessments immediately prior to PD or death were censored at the date of the last evaluable tumor assessment prior to those missing tumor assessments.
- measure
- Radiographic Progression-free Survival (rPFS)
- time Frame
- From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021)
- description
- Overall Survival (OS) was defined as the time (in months) from the date of randomization to the date of death due to any cause. If the patient was not known to have died, then OS was censored. The censoring date was date of the last study visit, or contact, until the cut-off date. The cut-off date was not used for last contact date, unless the patient was seen or contacted on that date. Final OS was analyzed at the time of Primary analysis (Primary Analysis cut-off date = 27-Jan-2021) and an updated descriptive analysis of OS was re-run at the time of final analysis (Final Analysis cut-off date 14-Dec-2023).
- measure
- Overall Survival (OS)
- time Frame
- From date of randomization until date of death from any cause, assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021) and up to 66 months (Final Analysis cut-off date = 14-Dec-2023)
- secondary Outcomes
- description
- In the Main Study, "randomized treatment" refers to the investigational arm (AAA617+BSC/BSoC) and the control arm (BSC/BSoC). In the sub-study, "study treatment" refers to the investigational arm (AAA617+BSC/BSoC) without randomization: 1. A randomized treatment-emergent adverse event (TEAE) is any adverse event that occurs from the start of randomized treatment to 30 days after the last administration of randomized treatment or prior to the initiation of subsequent anticancer treatment. 2. A study treatment-emergent adverse event (TEAE) is any adverse event that occurs from the start of study treatment to 30 days after the last administration of study treatment or prior to the initiation of subsequent anticancer treatment. The distribution of randomized/study treatment-emergent adverse events (TEAEs) was done via the analysis of frequencies for TEAEs and Serious Adverse Event (TESAEs), through the monitoring of relevant clinical and laboratory safety parameters.
- measure
- Number of Participants With Randomized/Study Treatment-emergent Adverse Events (TEAE)
- time Frame
- From randomization till 30 days safety follow-up, assessed up to 66 months (Final Analysis cut-off date = 14-Dec-2023)
- description
- Overall Response Rate (ORR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). ORR was based on RECIST 1.1 response for patients with evaluable disease at baseline per central review assessment.
- measure
- Overall Response Rate (ORR)
- time Frame
- From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021)
- description
- Disease control rate (DCR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) according to RECIST v1.1 per central review assessment.
- measure
- Disease Control Rate (DCR)
- time Frame
- From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021)
- description
- Duration of Response (DOR) was defined as the duration between the date of first documented Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) and the date of first documented radiographic progression or death due to any cause as per central review assessment.
- measure
- Duration of Response (DOR)
- time Frame
- From first documented evidence of CR or PR (the response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021)
- description
- Time to first Symptomatic Skeletal Event (SSE) was defined as the time (in months) from the date of randomization to the date of the SSE or death from any cause. The SSE date was the date of first new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, requirement for radiation therapy to relieve bone pain, or death due to any cause, whichever occurred first. SSE data for this endpoint were collected up through EOT visit. The censoring date was date of the last study visit (on or before the EOT visit).
- measure
- Time to First Symptomatic Skeletal Event (SSE)
- time Frame
- From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021)
- description
- Progression-free survival (PFS) was defined as the time (in months) from the date of randomization to the date of first evidence of radiographic, clinical or PSA progression or death due to any cause, whichever occurred first.
- measure
- Progression-free Survival (PFS)
- time Frame
- From date of randomization until date of progression or date of death from any cause, whichever come first, assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021)
- description
- Best percentage change from baseline in PSA level was defined as the maximum percent decrease at any time post-baseline, including only patients with a baseline value and at least one non-missing post-baseline value (scheduled and unscheduled).
- measure
- Best Percentage Change From Baseline in Prostate-specific Antigen (PSA) Level
- time Frame
- From date of randomization till 30 days safety fup, assessed up to approximately 32 months (Primary Analysis cut-off date = 27-Jan-2021)
- description
- PSA response was defined as the proportion of patients who had a \>= 50% decrease in PSA from baseline confirmed by a PSA measurement \>= 4 weeks later.
- measure
- Percentage of Participants Achieving Prostate-specific Antigen (PSA) Response
- time Frame
- From date of randomization till 30 days safety fup, assessed up to approximately 32 months (Primary Analysis cut-off date = 27-Jan-2021)
- description
- PSA80 response was defined as the proportion of participants who had a \>= 80% decrease in PSA from baseline confirmed by a PSA measurement \>= 4 weeks later.
- measure
- Prostate-specific Antigen 80 (PSA80) Response
- time Frame
- From date of randomization till 30 days safety fup, assessed up to approximately 32 months (Primary Analysis cut-off date = 27-Jan-2021)
- description
- Duration of PSA response was defined as the duration between the date of first document PSA response (i.e. \>= 50% decrease in PSA from Baseline) and the earliest date of PSA progression, where date of PSA progression was defined as: 1) Where a decline from baseline was documented, date that a \>= 25% increase in PSA and an absolute increase of 2 ng/mL or more from the nadir was documented and confirmed by a second consecutive value obtained at least 3 weeks later. Rises in PSA within the first 12 weeks of the date of first dose of randomized treatment were ignored; 2) Where no decline from baseline was documented, PSA progression was defined as a \>= 25% increase from the baseline value along with an increase in absolute value of 2 ng/mL or more after 12 weeks from the date of first dose of randomized treatment (without confirmation) as specified in the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) guidelines.
- measure
- Duration of PSA Response
- time Frame
- From date of first documented PSA response till 30 days safety fup, assessed up to approximately 32 months (Primary Analysis cut-off date = 27-Jan-2021)
- description
- Best percentage change from baseline in alkaline phosphatase (ALP) level was defined as the maximum percent decrease at any time post-baseline, including only patients with a baseline value and at least one non-missing post-baseline value (scheduled and unscheduled).
- measure
- Best Percentage Change From Baseline in Alkaline Phosphatase (ALP) Level
- time Frame
- From date of randomization till 30 days safety fup, assessed up to approximately 32 months (Primary Analysis cut-off date = 27-Jan-2021)
- description
- Best percentage change from baseline in lactate dehydrogenase (LDH) level was defined as the maximum percent decrease at any time post-baseline, including only patients with a baseline value and at least one non-missing post-baseline value (scheduled and unscheduled).
- measure
- Best Percentage Change From Baseline in Lactate Dehydrogenase (LDH) Level
- time Frame
- From date of randomization till 30 days safety fup, assessed up to approximately 32 months (Primary Analysis cut-off date = 27-Jan-2021)
Full study description
- brief Summary
- The primary objective of this study was to compare the two alternate primary endpoints of radiographic progression-free survival (rPFS) and overall survival (OS) in patients with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who received 177Lu-PSMA-617 in addition to best supportive/best standard of care (BSC/BSoC) versus patients treated with best supportive/best standard of care alone.
- detailed Description
- The study for each participant consisted of a Screening period, a Treatment period and a Follow-up period. Sub-study A dosimetry, PK and ECG sub-study was conducted in a non-randomized cohort (AAA617+BSC/BSoC) of 30 patients at sites in Germany to provide a more complete assessment of the safety aspects of AAA617. Aside from additional assessments to collect data for dosimetry, PK, urinary metabolites and ECG, patients in the sub-study were screened for eligibility, treated and followed up similarly to the AAA617+BSC/BSoC (investigational arm) patients in the main study. Screening and randomization: During the screening period of up to 28 days before starting randomized treatment, each participant was assessed for PSMA positivity by gallium (68Ga) gozetotide imaging PET/scan per the pre-defined read rules, by the Sponsor's central reader. Only patients with PSMA-positive metastatic PC and meeting all other inclusion/exclusion criteria were randomized in a 2:1 ratio to receive either 177Lu-PSMA-617 plus BSC/BSoC or BSC/BSoC only. Randomized patients were stratified on the following factors: LDH level (=\< or \> 260 UI/L), presence of liver metastases (Yes or No), eastern cooperative oncology group (ECOG) score (0-1 or 2) and inclusion of NAAD in the BSC/BSoC (at time of randomization (Yes or No)). Protocol- specified BSC/BSoC for each patient was initiated by the investigating physician prior to patient randomization and maintained throughout the study. On-study changes to BSC/BSoC were allowed and at the discretion of the investigating physician. Randomized treatment: "Randomized treatment" in this study refers to AAA617+BSC/BSoC (investigational arm) and BSC/BSoC only (control arm). For the sub-study, "study treatment" refers to AAA617+BSC/BSoC (also referred to as the investigational arm), as no randomization occurred in the sub-study. When discussing aspects of the study which are applicable to both the main and sub-study, the term 'randomized treatment' will be used throughout this document. The term 'study treatment' will be used only when specifically referring to the sub-study. Patients randomized to the investigational arm began AAA617 dosing within 28 days of randomization. These patients received BSC/BSoC and 7.4 GBq (+/-10%) AAA617 once every 6 weeks (+/- 1 week) for a maximum of 6 cycles. After the Cycle 4 treatment and prior to Cycle 5 treatment, the Investigator had to determine if: * The patient showed evidence of response (i.e. radiological, PSA, clinical benefit) * The patient had signs of residual disease on CT with contrast/MRI or bone scan * The patient had shown good tolerance to the AAA617 treatment If the patient met all of the criteria above and agreed to continue with additional treatment of AAA617 the investigator could administer a further 2 cycles. A maximum of 6 cycles of radioligand therapy was allowed. If the patient did not meet any of the criteria or did not agree to additional AAA617 treatment, then no additional doses of AAA617 were administered after Cycle 4. After the last cycle of AAA617, patients continued BSC/BSoC alone, as long as the investigator felt they were clinically benefiting or until they required a treatment regimen not allowed in this study. For both treatment arms, the cycle duration for Cycle 1-6 was 6 weeks and for Cycle 7 and beyond, 12 weeks. From Cycle 7 onwards, all patients from both treatment arms only received BSC/BSoC. End of treatment: An End of Treatment (EOT) visit was scheduled approximately 30 days after the last dose of AAA617 or the date of the BSC/BSoC end of treatment decision (whichever occurred later), but before the initiation of subsequent anti-cancer treatment, outside of what was allowed on study. Once a patient discontinued the randomized treatment part of the study for any reason, an EOT visit was scheduled. Long-term follow-up: Patients on the active part of the study at the time of the final analysis of OS had an EOT visit at the next planned visit after implementation of V5.0/5.1 of the protocol and moved into long-term follow-up, unless they specifically withdrew consent from long-term follow-up of the study. Patients who consented to be followed for long-term status updates, entered the long-term follow-up period after the EOT visit. The long-term follow-up period included the collection of rPFS (if the patient discontinued for reasons other than radiographic progression), OS, information about new treatments along with the patient's response to these treatments, AE assessment, and results of hematology and chemistry testing. During the follow-up, patients were contacted every 3 months (+/-1 month) via phone, email, or letter until a long-term follow-up study became available, until death or until withdrawal of consent, whichever occurred first.
Source references
- references
- citation
- Iravani A, Violet J, Azad A, Hofman MS. Lutetium-177 prostate-specific membrane antigen (PSMA) theranostics: practical nuances and intricacies. Prostate Cancer Prostatic Dis. 2020 Mar;23(1):38-52. doi: 10.1038/s41391-019-0174-x. Epub 2019 Oct 8.
- pmid
- 31595044
- type
- RESULT
- citation
- Chi KN, Yip SM, Bauman G, Probst S, Emmenegger U, Kollmannsberger CK, Martineau P, Niazi T, Pouliot F, Rendon R, Hotte SJ, Laidley DT, Saad F. 177Lu-PSMA-617 in Metastatic Castration-Resistant Prostate Cancer: A Review of the Evidence and Implications for Canadian Clinical Practice. Curr Oncol. 2024 Mar 7;31(3):1400-1415. doi: 10.3390/curroncol31030106.
- pmid
- 38534939
- type
- RESULT
- citation
- Fizazi K, Herrmann K, Krause BJ, Rahbar K, Chi KN, Morris MJ, Sartor O, Tagawa ST, Kendi AT, Vogelzang N, Calais J, Nagarajah J, Wei XX, Koshkin VS, Beauregard JM, Chang B, Ghouse R, DeSilvio M, Messmann RA, de Bono J. Health-related quality of life and pain outcomes with [177Lu]Lu-PSMA-617 plus standard of care versus standard of care in patients with metastatic castration-resistant prostate cancer (VISION): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2023 Jun;24(6):597-610. doi: 10.1016/S1470-2045(23)00158-4.
- pmid
- 37269841
- type
- RESULT
- citation
- Herrmann K, Rahbar K, Eiber M, Sparks R, Baca N, Krause BJ, Lassmann M, Jentzen W, Tang J, Chicco D, Klein P, Blumenstein L, Basque JR, Kurth J. Renal and Multiorgan Safety of 177Lu-PSMA-617 in Patients with Metastatic Castration-Resistant Prostate Cancer in the VISION Dosimetry Substudy. J Nucl Med. 2024 Jan 2;65(1):71-78. doi: 10.2967/jnumed.123.265448.
- pmid
- 38050121
- type
- RESULT
- citation
- Kuo PH, Yoo DC, Avery R, Seltzer M, Calais J, Nagarajah J, Weber WA, Fendler WP, Hofman MS, Krause BJ, Brackman M, Kpamegan E, Ghebremariam S, Benson T, Catafau AM, Kendi AT. A VISION Substudy of Reader Agreement on 68Ga-PSMA-11 PET/CT Scan Interpretation to Determine Patient Eligibility for 177Lu-PSMA-617 Radioligand Therapy. J Nucl Med. 2023 Aug;64(8):1259-1265. doi: 10.2967/jnumed.122.265077. Epub 2023 May 25.
- pmid
- 37230533
- type
- RESULT
- citation
- Sartor O, de Bono J, Chi KN, Fizazi K, Herrmann K, Rahbar K, Tagawa ST, Nordquist LT, Vaishampayan N, El-Haddad G, Park CH, Beer TM, Armour A, Perez-Contreras WJ, DeSilvio M, Kpamegan E, Gericke G, Messmann RA, Morris MJ, Krause BJ; VISION Investigators. Lutetium-177-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer. N Engl J Med. 2021 Sep 16;385(12):1091-1103. doi: 10.1056/NEJMoa2107322. Epub 2021 Jun 23.
- pmid
- 34161051
- type
- RESULT
- citation
- Armstrong AJ, Sartor O, de Bono J, Chi K, Fizazi K, Krause BJ, Herrmann K, Rahbar K, Tagawa ST, Saad F, Beer TM, Wu J, Mirante O, Morris MJ. Association of Declining Prostate-specific Antigen Levels with Clinical Outcomes in Patients with Metastatic Castration-resistant Prostate Cancer Receiving [177Lu]Lu-PSMA-617 in the Phase 3 VISION Trial. Eur Urol. 2024 Dec;86(6):552-562. doi: 10.1016/j.eururo.2024.08.021. Epub 2024 Sep 5.
- pmid
- 39242323
- type
- RESULT
- citation
- Chi KN, Armstrong AJ, Krause BJ, Herrmann K, Rahbar K, de Bono JS, Adra N, Garje R, Michalski JM, Kempel MM, Fizazi K, Morris MJ, Sartor O, Brackman M, DeSilvio M, Wilke C, Holder G, Tagawa ST. Safety Analyses of the Phase 3 VISION Trial of [177Lu]Lu-PSMA-617 in Patients with Metastatic Castration-resistant Prostate Cancer. Eur Urol. 2024 Apr;85(4):382-391. doi: 10.1016/j.eururo.2023.12.004. Epub 2024 Jan 6.
- pmid
- 38185538
- type
- RESULT
- citation
- Herrmann K, Gafita A, de Bono JS, Sartor O, Chi KN, Krause BJ, Rahbar K, Tagawa ST, Czernin J, El-Haddad G, Wong CC, Zhang Z, Wilke C, Mirante O, Morris MJ, Fizazi K. Multivariable models of outcomes with [177Lu]Lu-PSMA-617: analysis of the phase 3 VISION trial. EClinicalMedicine. 2024 Oct 4;77:102862. doi: 10.1016/j.eclinm.2024.102862. eCollection 2024 Nov.
- pmid
- 39430616
- type
- RESULT
- citation
- Kuo PH, Morris MJ, Hesterman J, Kendi AT, Rahbar K, Wei XX, Fang B, Adra N, Garje R, Michalski JM, Chi K, de Bono J, Fizazi K, Krause B, Sartor O, Tagawa ST, Ghebremariam S, Brackman M, Wong CC, Catafau AM, Benson T, Armstrong AJ, Herrmann K. Quantitative 68Ga-PSMA-11 PET and Clinical Outcomes in Metastatic Castration-resistant Prostate Cancer Following 177Lu-PSMA-617 (VISION Trial). Radiology. 2024 Aug;312(2):e233460. doi: 10.1148/radiol.233460.
- pmid
- 39162634
- type
- RESULT
- citation
- Morris MJ, de Bono J, Nagarajah J, Sartor O, Wei XX, Nordquist LT, Koshkin VS, Chi KN, Krause BJ, Herrmann K, Rahbar K, Vickers A, Mirante O, Ghouse R, Fizazi K, Tagawa ST. Correlation analyses of radiographic progression-free survival with clinical and health-related quality of life outcomes in metastatic castration-resistant prostate cancer: Analysis of the phase 3 VISION trial. Cancer. 2024 Oct 15;130(20):3426-3435. doi: 10.1002/cncr.35438. Epub 2024 Jun 21.
- pmid
- 39031642
- type
- RESULT
- citation
- Al-Khanaty A, Chen D, Walbaum J, Hennes D, Delgado C, Dinneen E, Eapen R, Hofman MS, Azad AA, Murphy DG, Lawrentschuk N, Perera M. Guideline of guidelines: lutetium-177 PSMA radioligand therapy in advanced prostate cancer. BJU Int. 2026 Sep;138(3):359-369. doi: 10.1111/bju.70283. Epub 2026 Apr 14.
- pmid
- 41979224
- type
- DERIVED
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-7ad944f6deaf1f5cd6122126
- edge id
- nct-edge-871200a89581f7b5df90
- requested nct id
- NCT03511664
- primary nct id
- NCT03511664
- source kind
- nci_explicit_reference_or_link
- source record id
- Source null
- source file sha256
- 89c3cbcb10a3e14c5ee4b607046c929e5902a798e71e758f8a712b0ae71413cf
- payload sha256
- 418d205bc01e7b5f8174d7f04337c408b21e709ff1947e3c85d4a2cd4cc339b3
- payload
- clinical indication matching status
- not_inferred
- end exclusive
- true
- id
- nct-edge-871200a89581f7b5df90
- link basis
- explicit_NCT_identifier_in_acquired_source
- nct id
- NCT03511664
- occurrences
- context exact
- ce (beta emitter radiation): </p> <div class="pdq-content-list"><ol id="_3264"><li> The phase III, international, open label <a href="/clinicaltrials/NCT03511664">VISION</a> study (NCT03511664) enrolled 831 patients with mCRPC previously treated with androgen receptor-directed therapy as well as taxane-based chemotherap
- end
- 599532
- exact text
- NCT03511664
- start
- 599521
- context exact
- p> <div class="pdq-content-list"><ol id="_3264"><li> The phase III, international, open label <a href="/clinicaltrials/NCT03511664">VISION</a> study (NCT03511664) enrolled 831 patients with mCRPC previously treated with androgen receptor-directed therapy as well as taxane-based chemotherapy. Eligible patients were requi
- end
- 599563
- exact text
- NCT03511664
- start
- 599552
- offset unit
- unicode_code_points
- source file
- /tmp/cancer-full-research/nci/raw/48a3f061dd2bbd22e8.html
- source file sha256
- 89c3cbcb10a3e14c5ee4b607046c929e5902a798e71e758f8a712b0ae71413cf
- source json pointer
- Source null
- source kind
- nci_explicit_reference_or_link
- source record id
- Source null
- source retrieved at
- 2026-09-09T23:22:14.334045+00:00
- source string basis
- UTF-8_text_with_universal_newline_translation
- source string sha256
- 351f45145a6c8591cdadd072763243033f8e1fa33cafecd55e4bac86e2b9edf3
- source title
- Prostate Cancer Treatment (PDQ®)–Health Professional Version
- source update dates
- context
- Updated: May 14, 2025
- datetime
- 2025-05-14T12:00:00Z
- display
- May 14, 2025
- release id
- ctgov-registry-7ad944f6deaf1f5cd6122126
- edge id
- nct-edge-a4ec12c3ab4f1f8e3f12
- requested nct id
- NCT03511664
- primary nct id
- NCT03511664
- source kind
- fda_spl_label
- source record id
- ade5aa80-b303-470f-8e79-7edea0c4a1bc
- source file sha256
- a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
- payload sha256
- a7e8d42bea3d2c430bda6b7cf5d487c712aa9713da187917daf1373a2185b90f
- payload
- application numbers
- NDA215833
- clinical indication matching status
- not_inferred
- end exclusive
- true
- id
- nct-edge-a4ec12c3ab4f1f8e3f12
- link basis
- explicit_NCT_identifier_in_acquired_source
- nct id
- NCT03511664
- occurrences
- context exact
- e Survival in PSMAfore VISION for Patients Previously Treated With ARPI Therapy and Taxane-Based Chemotherapy The efficacy of PLUVICTO was evaluated in VISION (NCT03511664), a randomized (2:1), multicenter, open-label trial of PLUVICTO plus BSoC (N = 551) versus BSoC alone (N = 280) in patients with progressive, PSMA-positive mAP
- end
- 7594
- exact text
- NCT03511664
- start
- 7583
- offset unit
- unicode_code_points
- source file
- /tmp/cancer-full-research/indications/raw/labels-00600.json
- source file sha256
- a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
- source json pointer
- /results/0/clinical_studies/0
- source kind
- fda_spl_label
- source record id
- ade5aa80-b303-470f-8e79-7edea0c4a1bc
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- 5b5f051ca5e41c25c49dfa7babddb319b0157aab02b5a559046cd33ffc59fc75
- spl effective time
- 20260812
- spl set id
- 14908037-2892-4d98-a053-253ce35afb1a
- release id
- ctgov-registry-7ad944f6deaf1f5cd6122126
- edge id
- nct-edge-c371e25fb47f1bebd9c1
- requested nct id
- NCT03511664
- primary nct id
- NCT03511664
- source kind
- fda_spl_label
- source record id
- 56f3be9c-a86f-4ce5-9e52-e9e57fb95464
- source file sha256
- bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
- payload sha256
- 397281828c45ac42f8c3418f1f825dc91c1621ac5a1bcea82eb7a240709ee7ac
- payload
- application numbers
- NDA214032
- clinical indication matching status
- not_inferred
- end exclusive
- true
- id
- nct-edge-c371e25fb47f1bebd9c1
- link basis
- explicit_NCT_identifier_in_acquired_source
- nct id
- NCT03511664
- occurrences
- context exact
- commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of <1%. In a randomized, multicenter, open-label clinical study (NCT03511664, referred to as Study 3) in which gallium Ga 68 gozetotide was used to identify PSMA-positive patients on PET imaging to determine eligibility for PSMA-directe
- end
- 1269
- exact text
- NCT03511664
- start
- 1258
- offset unit
- unicode_code_points
- source file
- /tmp/cancer-full-research/indications/raw/labels-00300.json
- source file sha256
- bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
- source json pointer
- /results/60/adverse_reactions/0
- source kind
- fda_spl_label
- source record id
- 56f3be9c-a86f-4ce5-9e52-e9e57fb95464
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- bcfd11b8cc1a8be9594db783f10a6cdd04ea5ea372e56d7c037a7187f7196e85
- spl effective time
- 20260615
- spl set id
- d4643b31-9b4f-673f-e053-2a95a90a559d
- release id
- ctgov-registry-7ad944f6deaf1f5cd6122126
- edge id
- nct-edge-d6e1e274fa001d12fb4a
- requested nct id
- NCT03511664
- primary nct id
- NCT03511664
- source kind
- fda_spl_label
- source record id
- 8683b06e-4901-4526-89ad-23a8fe2d1331
- source file sha256
- a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
- payload sha256
- 003310afc725e2b0b31e5cf9ad5ef4ba22785f20597e4e3741ce47d220737819
- payload
- application numbers
- NDA215841
- clinical indication matching status
- not_inferred
- end exclusive
- true
- id
- nct-edge-d6e1e274fa001d12fb4a
- link basis
- explicit_NCT_identifier_in_acquired_source
- nct id
- NCT03511664
- occurrences
- context exact
- commonly reported adverse reactions were nausea, diarrhea and dizziness, occurring at a rate of < 1%. In a randomized, multicenter, open-label clinical study (NCT03511664, referred to as Study 3) in which gallium Ga 68 gozetotide was used to identify PSMA-positive patients on PET imaging to determine eligibility for PSMA-directe
- end
- 1244
- exact text
- NCT03511664
- start
- 1233
- offset unit
- unicode_code_points
- source file
- /tmp/cancer-full-research/indications/raw/labels-00400.json
- source file sha256
- a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
- source json pointer
- /results/99/adverse_reactions/0
- source kind
- fda_spl_label
- source record id
- 8683b06e-4901-4526-89ad-23a8fe2d1331
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- fdb05126e84b6c6b83b885ea77dd1b3c8821ad692a36b3ec7457867df719814b
- spl effective time
- 20260115
- spl set id
- 8683b06e-4901-4526-89ad-23a8fe2d1331
Preserved source evidence · Not medical advice