TriangleNCT04689828 · STUDY IN CONTEXT
177Lu-PSMA-617 vs. Androgen Receptor-Directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
rPFS is defined as the time to radiographic progression by Prostate cancer working Group 3 (PCWG3)-modified RECIST v1.1 as assessed by Blinded independent central (BICR) review or death.
OS is defined as time to death for any cause.
rPFS2 by BICR is defined as time from the date of crossover (ARDT to 177Lu-PSMA-617) to the date of radiographic disease progression by BICR or death from any cause for participants who crossover from ARDT arm to Lu-PSMA treatment.
PFS is defined as time from date of randomization to the first documented progression by investigator's assessment (radiographic, clinical, or PSA progression) or death from any cause, whichever occurs first
PFS2 defined as time from date of randomization to the first documented progression by investigator's assessment (radiographic progression, clinical progression, PSA progression) or death from any cause, whichever occurs first, on next-line of therapy. Next-line therapy was defined as the first new (systemic) anti-neoplastic therapy initiated after discontinuation of study treatment regardless of end of treatment (EoT) reason.
PSA50 response was defined as the percentage of participants who achieved a ≥ 50% decrease from baseline that is confirmed by a second Prostate specific antigen (PSA) measurement ≥ 4 weeks.
Reported safety
Quality of life and patient-reported measures
EQ-5D · European Quality of Life (EuroQol) - 5 Domain 5 Level Scale (EQ-5D- 5L)
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT04689828
- qol key
- qol-0009
- source section id
- NCT04689828-om-0009
- source outcome index
- 9
- instrument
- EQ-5D
- instrument basis
- matched 'eq-5d' in the study's own wording
- scale title
- European Quality of Life (EuroQol) - 5 Domain 5 Level Scale (EQ-5D- 5L)
- measure definition
- EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Higher scores indicated greater levels of problems across each of the five dimensions.
- time frame
- From randomization up till 30 day safety Follow-up or week 48 of long term Follow-up for patients prematurely discontinued, assessed up to 43 months
- analysis role
- secondary
- reporting status
- NOT_POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
FACT · Functional Assessment of Cancer Therapy - Prostate (FACT-P) Questionnaire
Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT04689828
- qol key
- qol-0010
- source section id
- NCT04689828-om-0010
- source outcome index
- 10
- instrument
- FACT
- instrument basis
- matched 'fact-p' in the study's own wording
- scale title
- Functional Assessment of Cancer Therapy - Prostate (FACT-P) Questionnaire
- measure definition
- The FACT-P total score determines the level of prostate cancer specific health related quality of life (HRQoL). The higher the FACT-P score, the better the QoL. FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment. It is a combination of the FACT- General + the Prostate Cancer Subscale (PCS). The FACTGeneral (FACT-G) is a 27 item Quality of Life (QoL) measure that provides a total score as well as subscale scores: Physical (0-28), Functional (0-28), Social (0-28), and Emotional Well-being (0-24). The total score range is between 1-108, higher scores indicates better for total score and subscale scores. PCS is a 12-item prostate cancer subscale that asks about symptoms and problems specific to prostate cancer (Range 0-48, higher scores better). The FACT-P total score is the sum of all 5 subscale scores of the FACT-P questionnaire and ranges from 0-156. Higher scores indicate higher degree of functioning and better quality of life.
- time frame
- From randomization up till 30 day safety Follow-up or week 48 of long term Follow-up for patients prematurely discontinued, assessed up to 43 months
- analysis role
- secondary
- reporting status
- NOT_POSTED
- higher is better
- 1
- direction quote
- higher the FACT-P score, the better
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Brief Pain Inventory · Brief Pain Inventory - Short Form (BPI-SF) Questionnaire
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT04689828
- qol key
- qol-0011
- source section id
- NCT04689828-om-0011
- source outcome index
- 11
- instrument
- Brief Pain Inventory
- instrument basis
- matched 'brief pain inventory' in the study's own wording
- scale title
- Brief Pain Inventory - Short Form (BPI-SF) Questionnaire
- measure definition
- The BPI-SF is a publicly available instrument to assess the pain and includes severity and interference scores. BPI-SF is an 11-item selfreport questionnaire that is designed to assess the severity and impact of pain on daily functions of a participant. Pain severity score is a mean value for BPI-SF questions 3, 4, 5 and 6 (questions inquiring about the extent of pain, where the extent is ranked from 0 \[no pain\] to 10 \[pain as bad as you can imagine\]). Pain severity progression is defined as an increase in score of 30% or greater from baseline without decrease in analgesic use.
- time frame
- From screening up till 30 day safety Follow-up or week 48 of long term Follow-up for patients prematurely discontinued, assessed up to 43 months (estimated final OS analysis)
- analysis role
- secondary
- reporting status
- NOT_POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT04689828
- trial label
- 177Lu-PSMA-617 vs. Androgen Receptor-Directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 2
- qol Count
- 3
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT04689828
- outcome key
- om-0000
- source section id
- NCT04689828-om-0000
- source outcome index
- 0
- endpoint
- Radiographic Progression Free Survival (rPFS)
- endpoint definition
- rPFS is defined as the time to radiographic progression by Prostate cancer working Group 3 (PCWG3)-modified RECIST v1.1 as assessed by Blinded independent central (BICR) review or death.
- time origin
- median FU (randomization to event or censoring) 3.65 months (range 0-12.3)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The Full Analysis Set (FAS) comprised all participants to whom study treatment was assigned by randomization.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT04689828
- outcome key
- om-0001
- source section id
- NCT04689828-om-0001
- source outcome index
- 1
- endpoint
- Overall Survival (OS) (Key Secondary Endpoint)
- endpoint definition
- OS is defined as time to death for any cause.
- time origin
- approx. 26.9 months from randomization to cut-off
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- FAS comprised all participants to whom study treatment was assigned by randomization.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT04689828
- outcome key
- om-0002
- source section id
- NCT04689828-om-0002
- source outcome index
- 2
- endpoint
- Radiographic Progression Free Survival 2 (rPFS2) by Blinded Independent Central Review (BICR)
- endpoint definition
- rPFS2 by BICR is defined as time from the date of crossover (ARDT to 177Lu-PSMA-617) to the date of radiographic disease progression by BICR or death from any cause for participants who crossover from ARDT arm to Lu-PSMA treatment.
- time origin
- From date of crossover until second radiographic progression or death, whichever comes first, assessed up to approx. 32 months
- analysis role
- secondary
- reporting status
- NOT_POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT04689828
- outcome key
- om-0003
- source section id
- NCT04689828-om-0003
- source outcome index
- 3
- endpoint
- Progression Free Survival (PFS) by Investigator's Assessment
- endpoint definition
- PFS is defined as time from date of randomization to the first documented progression by investigator's assessment (radiographic, clinical, or PSA progression) or death from any cause, whichever occurs first
- time origin
- From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed upFrom date of randomization until date of death from any cause, assessed up to approx. 32 months
- analysis role
- secondary
- reporting status
- NOT_POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT04689828
- outcome key
- om-0004
- source section id
- NCT04689828-om-0004
- source outcome index
- 4
- endpoint
- Second Progression Free Survival (PFS2) by Investigator's Assessment
- endpoint definition
- PFS2 defined as time from date of randomization to the first documented progression by investigator's assessment (radiographic progression, clinical progression, PSA progression) or death from any cause, whichever occurs first, on next-line of therapy. Next-line therapy was defined as the first new (systemic) anti-neoplastic therapy initiated after discontinuation of study treatment regardless of end of treatment (EoT) reason.
- time origin
- From date of randomization until date of second progression or date of death from any cause, whichever comes first, assessed up to approx. 32 months
- analysis role
- secondary
- reporting status
- NOT_POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT04689828
- outcome key
- om-0005
- source section id
- NCT04689828-om-0005
- source outcome index
- 5
- endpoint
- PSA50 Response
- endpoint definition
- PSA50 response was defined as the percentage of participants who achieved a ≥ 50% decrease from baseline that is confirmed by a second Prostate specific antigen (PSA) measurement ≥ 4 weeks.
- time origin
- Weeks 12, 24, 48 and anytime during randomized phase
- analysis role
- secondary
- reporting status
- NOT_POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT04689828
- outcome key
- om-0000
- arm key
- OG000
- arm label
- 177Lu-PSMA-617 (AAA617)
- regimen
- Participants received 7.4 GBq (200 mCi) +/- 10% 177Lu-PSMA-617 once every 6 weeks for 6 cycles. Best supportive care, including ADT could be used.
- analyzed count
- 233
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04689828-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT04689828
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Androgen Receptor-directed Therapy (ARDT)
- regimen
- For participants randomized to the ARDT arm, the change of ARDT treatment was administered per the physician's orders. Best supportive care, including ADT could be used.
- analyzed count
- 234
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04689828-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT04689828
- outcome key
- om-0001
- arm key
- OG000
- arm label
- 177Lu-PSMA-617 (AAA617)
- regimen
- Participants received 7.4 GBq (200 mCi) +/- 10% 177Lu-PSMA-617 once every 6 weeks for 6 cycles. Best supportive care, including ADT could be used.
- analyzed count
- 234
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04689828-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT04689828
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Androgen Receptor-directed Therapy (ARDT)
- regimen
- For participants randomized to the ARDT arm, the change of ARDT treatment was administered per the physician's orders. Best supportive care, including ADT could be used.
- analyzed count
- 234
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04689828-om-0001#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT04689828
- harm key
- EG000
- source section id
- NCT04689828-ae
- event group key
- EG000
- event group label
- 177Lu-PSMA-617
- serious affected
- 46
- serious at risk
- 227
- other affected
- 217
- other at risk
- 227
- frequency threshold
- 5
- collection period
- From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization.
- event definition
- Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT04689828
- harm key
- EG001
- source section id
- NCT04689828-ae
- event group key
- EG001
- event group label
- Androgen Receptor-directed Therapy (ARDT)
- serious affected
- 76
- serious at risk
- 232
- other affected
- 208
- other at risk
- 232
- frequency threshold
- 5
- collection period
- From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization.
- event definition
- Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT04689828
- qol key
- qol-0009
- source section id
- NCT04689828-om-0009
- source outcome index
- 9
- instrument
- EQ-5D
- instrument basis
- matched 'eq-5d' in the study's own wording
- scale title
- European Quality of Life (EuroQol) - 5 Domain 5 Level Scale (EQ-5D- 5L)
- measure definition
- EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Higher scores indicated greater levels of problems across each of the five dimensions.
- time frame
- From randomization up till 30 day safety Follow-up or week 48 of long term Follow-up for patients prematurely discontinued, assessed up to 43 months
- analysis role
- secondary
- reporting status
- NOT_POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT04689828
- qol key
- qol-0010
- source section id
- NCT04689828-om-0010
- source outcome index
- 10
- instrument
- FACT
- instrument basis
- matched 'fact-p' in the study's own wording
- scale title
- Functional Assessment of Cancer Therapy - Prostate (FACT-P) Questionnaire
- measure definition
- The FACT-P total score determines the level of prostate cancer specific health related quality of life (HRQoL). The higher the FACT-P score, the better the QoL. FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment. It is a combination of the FACT- General + the Prostate Cancer Subscale (PCS). The FACTGeneral (FACT-G) is a 27 item Quality of Life (QoL) measure that provides a total score as well as subscale scores: Physical (0-28), Functional (0-28), Social (0-28), and Emotional Well-being (0-24). The total score range is between 1-108, higher scores indicates better for total score and subscale scores. PCS is a 12-item prostate cancer subscale that asks about symptoms and problems specific to prostate cancer (Range 0-48, higher scores better). The FACT-P total score is the sum of all 5 subscale scores of the FACT-P questionnaire and ranges from 0-156. Higher scores indicate higher degree of functioning and better quality of life.
- time frame
- From randomization up till 30 day safety Follow-up or week 48 of long term Follow-up for patients prematurely discontinued, assessed up to 43 months
- analysis role
- secondary
- reporting status
- NOT_POSTED
- higher is better
- 1
- direction quote
- higher the FACT-P score, the better
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT04689828
- qol key
- qol-0011
- source section id
- NCT04689828-om-0011
- source outcome index
- 11
- instrument
- Brief Pain Inventory
- instrument basis
- matched 'brief pain inventory' in the study's own wording
- scale title
- Brief Pain Inventory - Short Form (BPI-SF) Questionnaire
- measure definition
- The BPI-SF is a publicly available instrument to assess the pain and includes severity and interference scores. BPI-SF is an 11-item selfreport questionnaire that is designed to assess the severity and impact of pain on daily functions of a participant. Pain severity score is a mean value for BPI-SF questions 3, 4, 5 and 6 (questions inquiring about the extent of pain, where the extent is ranked from 0 \[no pain\] to 10 \[pain as bad as you can imagine\]). Pain severity progression is defined as an increase in score of 30% or greater from baseline without decrease in analgesic use.
- time frame
- From screening up till 30 day safety Follow-up or week 48 of long term Follow-up for patients prematurely discontinued, assessed up to 43 months (estimated final OS analysis)
- analysis role
- secondary
- reporting status
- NOT_POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- setting source links
Preserved source evidence · Not medical advice