NCT03395197 · CITED IN SOURCE DOCUMENTS

Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC

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: ACTIVE NOT RECRUITING
Registry last update: 2026-09-08

This study compares rPFS in men with mCRPC treated with talazoparib plus enzalutamide vs. enzalutamide after confirmation of the starting dose of talazoparib in combination with enzalutamide.

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.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Occuring Within the First 66 Days of Dosing - Part 1

→

outcome · POSTED

Number of Participants With All-Causality Clustered Treatment-Emergent Cytopenias by Preferred Term (PT) and Max CTCAE Grade Occuring Within the First 66 Days of Dosing - Part 1

→

outcome · POSTED

Number of Participants With All-Causality TEAEs During the Overall Period of Part 1

→

outcome · POSTED

Number of Participants With Treatment-Related TEAEs During the Overall Period of Part 1

→

outcome · POSTED

Number of Participants With All-Causality Clustered Treatment-Emergent Cytopenias by PT and Max CTCAE Grade Occuring Anytime After Dosing - Part 1

→

outcome · POSTED

Number of Participants With Treatment-Related Clustered Treatment-Emergent Cytopenias by PT and Max CTCAE Grade in >=10% of Participants Occuring Anytime After Dosing - Part 1

→

outcome · POSTED

Blinded Independent Central Review (BICR) Assessed Radiographic Progression-Free Survival (rPFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for All-Comers - Part 2 Cohort 1

→

outcome · POSTED

BICR Assessed rPFS Per RECIST 1.1 in Patients With DDR Deficiencies - Part 2

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→

Who could take part

eligibility Criteria: Inclusion Criteria: Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell or signet cell features Asymptomatic or mildly symptomatic metastatic castration resistant prostate cancer (mCRPC) (score on BPI-SF Question #3 must be \< 4). For enrollment into Part 2 only (optional in Part 1): assessment of DDR mutation status Consent to a saliva sample collection for a germline comparator unless prohibited by local regulations or ethics committee decision (optional for patients in Part 1). Surgically or medically castrated, with serum testosterone ≤ 50 ng/dL (≤ 1.73 nmol/L) at screening. Metastatic disease in bone documented on bone scan or in soft tissue documented on CT/MRI scan. Progressive disease at study entry in the setting of medical or surgical castration as defined by 1 or more of the following 3 criteria: * Prostate specific antigen (PSA) progression defined by a minimum of 2 rising PSA values from 3 consecutive assessments with an interval of at least 7 days between assessments.. * Soft tissue disease progression as defined by RECIST 1.1. * Bone disease progression defined by Prostate Cancer Working Group 3 (PCWG3) with 2 or more new metastatic bone lesions on a whole body radionuclide bone scan. Ongoing bisphosphonate or denosumab use prior to Day 1 (Part 1) or randomization (Part 2) is allowed but not mandatory. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1. Life expectancy ≥ 12 months as assessed by the investigator. Able to swallow the study drug and have no known intolerance to study drugs or excipients. Must agree to use a condom when having sex with a partner from the time of the first dose of study drug through 4 months after last dose of study treatment. Must also agree for female partner of childbearing potential to use an additional highly effective form of contraception from the time of the first dose of study treatment through 4 months after last dose of study treatment when having sex with a non pregnant female partner of childbearing potential. Must agree not to donate sperm from the first dose of study drug to 4 months after the last dose of study drug. Evidence of a personally signed and dated informed consent document (and molecular prescreening consent if appropriate) indicating that the patient \[or a legally acceptable representative/legal guardian\] has been informed of all pertinent aspects of the study. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures Exclusion Criteria: Any prior systemic cancer treatment initiated in in the non metastatic CRPC and mCRPC disease state. Patients whose only evidence of metastasis is adenopathy below the aortic bifurcation. Prior treatment with second-generation androgen receptor inhibitors (enzalutamide, apalutamide, and darolutamide), a PARP inhibitor, cyclophosphamide, or mitoxantrone for prostate cancer. Prior treatment with platinum-based chemotherapy within 6 months (from the last dose) prior to Day 1 (Part 1) or randomization (Part 2), or any history of disease progression on platinum-based therapy within 6 months (from the last dose). Treatment with cytotoxic chemotherapy, biologic therapy including sipuleucel T, or radionuclide therapy received in the castration-sensitive prostate cancer is NOT exclusionary if discontinued in the 28 days prior to Day 1 (Part 1) or randomization (Part 2). Treatment with any investigational agent within 4 weeks before Day 1 (Part 1) or randomization (Part 2). Prior treatment with opioids for pain related to either primary prostate cancer or metastasis within 28 days prior to Day 1 (Part 1) or randomization (Part 2). Current use of potent P-gp inhibitors within 7 days prior to Day 1 (Part 1) or randomization (Part 2). Major surgery (as defined by the investigator) within 2 weeks before Day 1 (Part 1) or randomization (Part 2), or palliative localized radiation therapy within 3 weeks before randomization (Part 2). Clinically significant cardiovascular disease Significant renal dysfunction as defined by any of the following laboratory abnormalities: • Renal: eGFR \< 30 mL/min/1.73 m2 by the MDRD equation (available via www.mdrd.com). Patients enrolled in Part 1 only: Moderate renal impairment (eGFR 30-59 mL/min/1.73 m2) at screening. Significant hepatic dysfunction as defined by any of the following laboratory abnormalities on screening labs: * Total serum bilirubin \>1.5 times the upper limit of normal (ULN) (\>3 × ULN for patients with documented Gilbert syndrome or for whom indirect bilirubin concentrations suggest an extrahepatic source of elevation). * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2.5 times ULN (\>5 × ULN if liver function abnormalities are due to hepatic metastasis). * Albumin \<2.8 g/dL Absolute neutrophil count \< 1500/µL, platelets \< 100,000/µL, or hemoglobin \< 9 g/dL (may not have received growth factors or blood transfusions within 14 days before obtaining the hematology values at screening). Known or suspected brain metastasis or active leptomeningeal disease. Symptomatic or impending spinal cord compression or cauda equina syndrome. Any history of myelodysplastic syndrome, acute myeloid leukemia, or prior malignancy except any of the following: * Carcinoma in situ or non melanoma skin cancer * Any prior malignancies ≥3 years before randomization with no subsequent evidence of recurrence or progression regardless of the stage. * Stage 0 or Stage 1 cancer \<3 years before randomization that has a remote probability of recurrence or progression in the opinion of the investigator Gastrointestinal disorder affecting absorption. Fertile male subjects who are unwilling or unable to use highly effective methods of contraception for the duration of the study and for 4 months after the last dose of investigational product. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or patients who are Pfizer employees, including their family members, directly involved in the conduct of the study. Other acute or chronic medical (concurrent disease, infection, or comorbidity) or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that interferes with ability to participate in the study, may increase the risk associated with study participation or investigational product administration, or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study. History of seizure or any condition that may predispose to seizure (eg, prior cortical stroke, significant brain trauma). Also, history of loss of consciousness or transient ischemic attack within 12 months of randomization (Part 2).
gender Based: true
gender Description: Men at least 18 years of age. For Japan, at least 20 years of age.
healthy Volunteers: false
minimum Age: 18 Years
sex: MALE
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Talazoparib plus enzalutamide
intervention Names
Drug: Talazoparib with enzalutamide
label
Combination arm
type
EXPERIMENTAL
description
Ezalutamide plus placebo
intervention Names
Drug: Placebo with enzalutamide
label
Monotherapy arm
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
Combination arm
description
Talazoparib 0.5 mg/day plus enzalutamide 160mg/day
name
Talazoparib with enzalutamide
type
DRUG
arm Group Labels
Monotherapy arm
description
Placebo plus enzalutamide 160 mg/day
name
Placebo with enzalutamide
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

intervention Model Description

To assess radiographic PFS in men with mCRPC (with no systemic treatments initiated after documentation of mCRCP) treated with talazoparib and enzalutamide vs. placebo plus enzalutamide

masking Info

masking: QUADRUPLE
masking Description: Double-blind
who Masked: PARTICIPANT
CARE_PROVIDER
INVESTIGATOR
OUTCOMES_ASSESSOR

primary Purpose

TREATMENT

Enrollment

count: 1054
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
An adverse event (AE) was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. TEAEs are defined as newly occurring AEs or those worsening after first dose. As per Common Terminology Criteria for Adverse Events (CTCAE) version 4, Grade 1= mild AE; Grade 2= moderate AE; Grade 3= severe AE; Grade 4= life-threatening or disabling AE; Grade 5= death related to an AE. Serious TEAE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. SAEs were determined according to the investigator's assessment. Results as of 16 Aug 2022 are reported.
measure
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Occuring Within the First 66 Days of Dosing - Part 1
time Frame
Post dose on Day 1 up to Day 66 in Part 1
description
An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. TEAEs are defined as newly occurring AEs or those worsening after first dose. As per CTCAE version 4, Grade 1=mild AE; Grade 2=moderate AE; Grade 3=severe AE; Grade 4=life-threatening or disabling AE; Grade 5=death related to an AE. Medical Dictionary for Regulatory Activities (MedDRA) v25.0 coding dictionary applied. PTs for the cluster terms are: ANEMIA, including Anemia, Hematocrit decreased, Hemoglobin decreased, and Red blood cell count decreased; THROMBOCYTOPENIA, including, Thrombocytopenia and Platelet count decreased; NEUTROPENIA, including Febrile neutropenia, Neutropenia and Neutrophil count decreased; LEUKOPENIA, including Leukopenia, White blood cell count decreased. Events in any grade with at least 1 occurrence in participants are reported for this outcome measure. Results as of 16 Aug 2022 are reported.
measure
Number of Participants With All-Causality Clustered Treatment-Emergent Cytopenias by Preferred Term (PT) and Max CTCAE Grade Occuring Within the First 66 Days of Dosing - Part 1
time Frame
Post dose on Day 1 up to Day 66 in Part 1
description
An adverse event (AE) was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. TEAEs are defined as newly occurring AEs or those worsening after first dose. As per CTCAE version 4, Grade 1= mild AE; Grade 2= moderate AE; Grade 3= severe AE; Grade 4= life-threatening or disabling AE; Grade 5= death related to an AE. Serious TEAE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. SAEs were determined according to the investigator's assessment. Results as of 16 Aug 2022 are reported.
measure
Number of Participants With All-Causality TEAEs During the Overall Period of Part 1
time Frame
Post dose on Day 1 up to 28 days after the last dose of study intervention, or before new systemic antineoplastic therapy, whichever occurred first (maximum of 235.14 weeks)
description
An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. TEAEs are defined as newly occurring AEs or those worsening after first dose. Treatment-related AE was any untoward medical occurrence attributed to study intervention in a participant who received study intervention. As per CTCAE version 4, Grade 1= mild AE; Grade 2= moderate AE; Grade 3= severe AE; Grade 4= life-threatening or disabling AE; Grade 5= death related to an AE. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. SAEs were determined according to the investigator's assessment. Results as of 16 Aug 2022 are reported.
measure
Number of Participants With Treatment-Related TEAEs During the Overall Period of Part 1
time Frame
Post dose on Day 1 up to 28 days after the last dose of study intervention, or before new systemic antineoplastic therapy, whichever occurred first (maximum of 235.14 weeks)
description
An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. TEAEs are defined as newly occurring AEs or those worsening after first dose. As per CTCAE version 4, Grade 1=mild AE; Grade 2=moderate AE; Grade 3=severe AE; Grade 4=life-threatening or disabling AE; Grade 5=death related to an AE. MedDRA v25.0 coding dictionary applied. PTs for the cluster terms are: ANEMIA, including Anemia, Hematocrit decreased, Hemoglobin decreased, and Red blood cell count decreased; THROMBOCYTOPENIA, including, Thrombocytopenia and Platelet count decreased; NEUTROPENIA, including Febrile neutropenia, Neutropenia and Neutrophil count decreased; LEUKOPENIA, including Leukopenia, White blood cell count decreased. Events in any grade with at least 1 occurrence in participants are reported for this outcome measure. Results as of 16 Aug 2022 are reported.
measure
Number of Participants With All-Causality Clustered Treatment-Emergent Cytopenias by PT and Max CTCAE Grade Occuring Anytime After Dosing - Part 1
time Frame
Post dose on Day 1 up to 28 days after the last dose of study intervention, or before new systemic antineoplastic therapy, whichever occurred first (maximum of 235.14 weeks)
description
An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. TEAEs are newly occurring AEs or those worsening after first dose. Treatment-related AE was any AE attributed to study intervention in a participant who received study intervention. As per CTCAE version 4, Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening or disabling; Grade 5=death related to an AE. MedDRA v25.0 coding dictionary applied. PTs for the cluster terms are: ANEMIA, including Anemia, Hematocrit decreased, Hemoglobin decreased, and Red blood cell count decreased; THROMBOCYTOPENIA, including, Thrombocytopenia and Platelet count decreased; NEUTROPENIA, including Febrile neutropenia, Neutropenia and Neutrophil count decreased; LEUKOPENIA, including Leukopenia, White blood cell count decreased. Events in any grade with incidence in \>=10% of participants are reported. Results as of 16 Aug 2022 are reported.
measure
Number of Participants With Treatment-Related Clustered Treatment-Emergent Cytopenias by PT and Max CTCAE Grade in >=10% of Participants Occuring Anytime After Dosing - Part 1
time Frame
Post dose on Day 1 up to 28 days after the last dose of study intervention, or before new systemic antineoplastic therapy, whichever occurred first (maximum of 235.14 weeks)
description
rPFS is defined as the time from the date of randomization to first objective evidence of radiographic progression as assessed in soft tissue per RECIST 1.1, or death, whichever occurs first. Soft tissue disease status was assessed at regular intervals during the course of the study by computed tomography (CT) of chest and CT or magnetic resonance imaging (MRI) of abdomen and pelvis. Progression is defined using RECIST 1.1 as a \>=20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Results as of 16 Aug 2022 are reported for this outcome measure.
measure
Blinded Independent Central Review (BICR) Assessed Radiographic Progression-Free Survival (rPFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for All-Comers - Part 2 Cohort 1
time Frame
From the start of treatment to the time of first documented progression, or death (maximum up to 42 months)
description
rPFS is defined as the time from the date of randomization to first objective evidence of radiographic progression as assessed in soft tissue per RECIST 1.1, or death, whichever occurs first. Soft tissue disease status was assessed at regular intervals during the course of the study by CT of chest and CT or MRI of abdomen and pelvis. Results as of 03 Oct 2022 are reported for this outcome measure.
measure
BICR Assessed rPFS Per RECIST 1.1 in Patients With DDR Deficiencies - Part 2
time Frame
From the start of treatment to the time of first documented progression, or death (maximum up to 38 months)

Full study description

brief Summary: This study compares rPFS in men with mCRPC treated with talazoparib plus enzalutamide vs. enzalutamide after confirmation of the starting dose of talazoparib in combination with enzalutamide.
detailed Description: Part 1 is an open-label, non-randomized, safety and PK run-in study designed to confirm the starting dose of talazoparib in combination with enzalutamide through assessment of target safety events and PK at select sites. Part 2 is a randomized, double-blind, placebo-controlled, multinational study comparing talazoparib plus enzalutamide vs. placebo plus enzalutamide in patients with mCRPC.

Source references

references

citation
Yajima S, Yoshida S, Chen W, Fukushima H, Tanaka H, Sato H, Hirakawa A, Masuda H, Fujii Y. Exploratory Time-Dependent Patterns in Estimated Treatment Effect of Talazoparib Plus Enzalutamide in HRR Non-Deficient or Unknown Metastatic Castration-Resistant Prostate Cancer: A Post Hoc Analysis of the TALAPRO-2 Trial. Int J Urol. 2026 Jul;33(7):e70582. doi: 10.1111/iju.70582.
pmid
42502892
type
DERIVED
citation
Agarwal N, Azad AA, Carles J, Fay AP, Matsubara N, Szczylik C, De Giorgi U, Joung JY, Fong PCC, Voog E, Jones RJ, Shore ND, Saad F, Dunshee C, Zschabitz S, Oldenburg J, Lin X, Healy CG, Kalac M, Kennedy D, Fizazi K. A plain language summary of the final overall survival results from the TALAPRO-2 study comparing talazoparib plus enzalutamide with placebo plus enzalutamide for patients with advanced prostate cancer. Future Oncol. 2026 Jun;22(14):1687-1702. doi: 10.1080/14796694.2026.2668552. Epub 2026 Jun 9.
pmid
42261883
type
DERIVED
citation
Fizazi K, Azad AA, Matsubara N, Carles J, Fay AP, De Giorgi U, Joung JY, Fong PCC, Voog E, Jones RJ, Shore ND, Dunshee C, Zschabitz S, Oldenburg J, Ye D, Lin X, Kalac M, Laird AD, Kennedy D, Agarwal N. A plain language summary of the final overall survival results from the TALAPRO-2 study comparing talazoparib plus enzalutamide versus placebo plus enzalutamide for patients with advanced prostate cancer and changes in specific DNA repair genes. Future Oncol. 2026 Jun;22(14):1669-1685. doi: 10.1080/14796694.2026.2661093. Epub 2026 Jun 4.
pmid
42237765
type
DERIVED
citation
Agarwal N, Azad AA, Carles J, Fay AP, Matsubara N, Szczylik C, De Giorgi U, Young Joung J, Fong PCC, Voog E, Jones RJ, Shore ND, Saad F, Dunshee C, Zschabitz S, Oldenburg J, Lin X, Healy CG, Kalac M, Kennedy D, Fizazi K. Talazoparib plus enzalutamide in men with metastatic castration-resistant prostate cancer: final overall survival results from the randomised, placebo-controlled, phase 3 TALAPRO-2 trial. Lancet. 2025 Aug 2;406(10502):447-460. doi: 10.1016/S0140-6736(25)00684-1. Epub 2025 Jul 16.
pmid
40683290
type
DERIVED
citation
Fizazi K, Azad AA, Matsubara N, Carles J, Fay AP, De Giorgi U, Young Joung J, Fong PCC, Voog E, Jones RJ, Shore ND, Dunshee C, Zschabitz S, Oldenburg J, Ye D, Lin X, Kalac M, Douglas Laird A, Kennedy D, Agarwal N. Talazoparib plus enzalutamide in men with HRR-deficient metastatic castration-resistant prostate cancer: final overall survival results from the randomised, placebo-controlled, phase 3 TALAPRO-2 trial. Lancet. 2025 Aug 2;406(10502):461-474. doi: 10.1016/S0140-6736(25)00683-X. Epub 2025 Jul 16.
pmid
40683287
type
DERIVED
citation
Fay AP, Fizazi K, Matsubara N, Azad AA, Saad F, De Giorgi U, Joung JY, Fong PCC, Jones RJ, Zschabitz S, Oldenburg J, Shore ND, Dunshee C, Carles J, Cislo P, Chang J, Healy CG, Niyazov A, Agarwal N. First-line talazoparib plus enzalutamide versus placebo plus enzalutamide in men with metastatic castration-resistant prostate cancer and homologous recombination repair gene alterations: patient-reported outcomes from the randomised, double-blind, placebo-controlled, phase 3 TALAPRO-2 trial. Lancet Oncol. 2025 Apr;26(4):481-490. doi: 10.1016/S1470-2045(25)00031-2.
pmid
40179907
type
DERIVED
citation
Matsubara N, Azad AA, Agarwal N, Saad F, De Giorgi U, Joung JY, Fong PCC, Jones RJ, Zschabitz S, Oldenburg J, Shore ND, Dunshee C, Carles J, Fay AP, Cislo P, Chang J, Healy CG, Niyazov A, Fizazi K. First-line talazoparib plus enzalutamide versus placebo plus enzalutamide for metastatic castration-resistant prostate cancer: patient-reported outcomes from the randomised, double-blind, placebo-controlled, phase 3 TALAPRO-2 trial. Lancet Oncol. 2025 Apr;26(4):470-480. doi: 10.1016/S1470-2045(25)00030-0.
pmid
40179906
type
DERIVED
citation
Matsubara N, Miyake H, Uemura H, Mizokami A, Kikukawa H, Kosaka T, Nishimura K, Nakamura M, Kobayashi K, Komaru A, Mori Y, Toyoizumi S, Hori N, Umeyama Y, Uemura H. Phase 3 Study of Talazoparib Plus Enzalutamide Versus Placebo Plus Enzalutamide as First-Line Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer: TALAPRO-2 Japanese Subgroup Analysis. Cancer Med. 2025 Jan;14(1):e70333. doi: 10.1002/cam4.70333.
pmid
39737542
type
DERIVED
citation
Azad AA, Fizazi K, Matsubara N, Saad F, De Giorgi U, Joung JY, Fong PCC, Jones RJ, Zschabitz S, Oldenburg J, Shore ND, Dunshee C, Carles J, Fay AP, Lin X, DeAnnuntis L, Di Santo N, Zielinski MA, Agarwal N. Talazoparib plus enzalutamide in metastatic castration-resistant prostate cancer: Safety analyses from the randomized, placebo-controlled, phase III TALAPRO-2 study. Eur J Cancer. 2024 Dec;213:115078. doi: 10.1016/j.ejca.2024.115078. Epub 2024 Oct 20.
pmid
39486165
type
DERIVED
citation
Agarwal N, Saad F, Azad AA, Mateo J, Matsubara N, Shore ND, Chakrabarti J, Chen HC, Lanzalone S, Niyazov A, Fizazi K. The TALAPRO-3 study design: a plain language summary. Future Oncol. 2024;20(30):2225-2231. doi: 10.1080/14796694.2024.2363131. Epub 2024 Jul 24.
pmid
39451095
type
DERIVED
citation
Agarwal N, Azad AA, Carles J, Fay AP, Matsubara N, Heinrich D, Szczylik C, De Giorgi U, Joung JY, Fong PCC, Voog E, Jones RJ, Shore ND, Dunshee C, Zschabitz S, Oldenburg J, Lin X, Healy CG, Di Santo N, Zohren F, Fizazi K. Plain language summary of the results from the TALAPRO-2 study: Talazoparib plus enzalutamide versus placebo plus enzalutamide for patients with advanced prostate cancer. Future Oncol. 2024;20(29):2123-2135. doi: 10.1080/14796694.2024.2362108. Epub 2024 Jul 12.
pmid
38995237
type
DERIVED
citation
Heiss BL, Chang E, Gao X, Truong T, Brave MH, Bloomquist E, Shah A, Hamed S, Kraft J, Chiu HJ, Ricks TK, Tilley A, Pierce WF, Tang L, Abukhdeir A, Kalavar S, Philip R, Tang S, Pazdur R, Amiri-Kordestani L, Kluetz PG, Suzman DL. US Food and Drug Administration Approval Summary: Talazoparib in Combination With Enzalutamide for Treatment of Patients With Homologous Recombination Repair Gene-Mutated Metastatic Castration-Resistant Prostate Cancer. J Clin Oncol. 2024 May 20;42(15):1851-1860. doi: 10.1200/JCO.23.02182. Epub 2024 Mar 7.
pmid
38452327
type
DERIVED