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Prostate Cancer (Adenocarcinoma)Phase 2TALENTNCT06844383

A Study of Talazoparib With or Without Enzalutamide in People With Prostate Cancer Who Have Previously Received Abiraterone Acetate or Darolutamide

A Phase 2 study testing Talazoparib with enzalutamide and Talazoparib in people with Prostate Cancer (Adenocarcinoma) and mCRPC (Metastatic Castration-resistant Prostate Cancer), run by Prostate Cancer Clinical Trials Consortium at 8 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to find out whether talazoparib in combination with enzalutamide or talazoparib alone delays cancer progression in people with metastatic castration-resistant prostate cancer (mCRPC) who have homologous recombination repair (HRR) mutations and have previously received abiraterone acetate… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Talazoparib with enzalutamide and Talazoparib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
8 sitesUnited States
Study dates
4 May 2026to Mar 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willing and able to provide, or have a legally authorized representative provide, written informed consent and privacy authorization for the release of personal health information. A signed informed consent must be obtained before screening procedures are performed.
  • NOTE: Privacy authorization may be either included in the informed consent or obtained separately.
  • Participants ≥ 18 years of age.
  • Are willing to be randomized into either study arm and adhere to the study protocol.
  • Ability to swallow study capsules and/or tablets whole.
  • Are willing to remain on study treatment and to continue undergoing study imaging despite PSA progression unless clinically deteriorating.
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  • Histological or cytological proof of predominant adenocarcinoma of the prostate.
  • Presence of a pathogenic homologous recombination repair mutation in at least one of the following genes: BRCA1, BRCA2, ATM (limited to 15% of enrolled participants), CDK12, CHEK2, PALB2, MLH1, NBN, ATR, FANCA, MRE11A, RAD51C. Assessment of HRR mutation status by germline or somatic testing. All testing must be per Clinical Laboratory Improvement Amendments (CLIA)-certified assay and may have occurred at any time prior to or at screening (not required to be completed within the screening window).
  • Metastatic castration-resistant prostate cancer (mCRPC) as demonstrated by one or both of the following:
  • Metastatic disease documented by conventional imaging: computed tomography (CT)/magnetic resonance imaging (MRI) chest/abdomen/pelvis and bone scan are required to be performed, but metastases do not need to be seen on both modalities. Measurable disease is not required.
  • Unequivocal prostate-specific membrane antigen (PSMA) positron emission tomography (PET) only defined metastatic disease with negative conventional imaging. PSMA PET imaging is not required to be performed, but may be used to document metastases when relevant.
  • Progressed either via a minimum of 2 rising PSA levels with a minimun of a 1-week interval between each determination or via radiographic progression by any form of imaging while receiving either abiraterone acetate with prednisone for mHSPC or locally advanced disease, OR darolutamide for mHSPC, locally advanced disease, or non-metastatic castration-resistant disease.
  • Progressive disease at start of treatment and in the setting of medical or surgical castration as defined by 1 or more of the following 4 criteria:
  • PSA progression defined as 2 rising PSA levels, above an initial reference value, taken with a minimum of a 1-week interval. If PSA rise is the only indication of progression at start of study treatment, a minimum PSA of 1.0 ng/mL is required and all measured PSA values have to be considered to make a determination of progression.
  • Soft tissue disease progression as defined by RECIST 1.1.
  • Bone disease progression defined by PCWG3 with 2 or more new metastatic bone lesions on a whole-body radionuclide bone scan.
  • Appearance of newly identified, convincingly positive lesion(s) consistent with metastatic prostate cancer on PSMA PET.
  • Surgically or medically castrated, with testosterone levels of <50 ng/dL. If the participant is medically castrated, continuous dosing with a gonadotropin-releasing hormone agonist or antagonist must be demonstrated by testosterone level of <50 ng/dL and planned to continue throughout study participation.
  • Eastern Cooperative Oncology Group (ECOG) status of ≤2 (Appendix A: Performance Status Criteria).
  • Normal organ function with acceptable initial laboratory values within 35 days of treatment start:
  • Absolute neutrophil count ≥ 1,500/µl
  • Hemoglobin ≥ 9g/dl
  • Platelet count ≥ 100,000/µl
  • Creatinine ≤ 1.5 x the institutional upper limit of normal (ULN)
  • Potassium ≥ 3.5 mmol/L (within institutional normal range)
  • Bilirubin ≤ 1.3 x ULN (unless documented Gilbert's disease)
  • Serum glutamic oxaloacetic transaminase/aspartate transaminase (AST) ≤ 2.5 x ULN
  • Serum glutamic pyruvic transaminase/ alanine transaminase (ALT) ≤ 2.5 x ULN
  • Participants must agree to use a medically acceptable method of birth control (e.g., spermicide in conjunction with a barrier such as a condom) or sexual abstinence for the duration of the study, including 4 months after the last dose of study drug. Sperm donation is prohibited during the study and for 4 months after the last dose of study drug. Female partners must use hormonal or barrier contraception unless postmenopausal or abstinent.

Who cannot join

  • Any other active malignancy at time of first dose of study treatment or diagnosis of another malignancy within 2 years prior to first dose of study treatment that requires active treatment, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer or superficial bladder cancer.
  • Prior treatment for metastatic CRPC with an ARPI for ≥ 12 weeks.
  • Prior treatment for non-metastatic CRPC with abiraterone acetate with prednisone, enzalutamide, or apalutamide for ≥ 12 weeks.
  • Participants who received chemotherapy for castration-sensitive prostate cancer are still eligible provided chemotherapy was completed ≥ 28 days prior to start of study treatment.
  • Participants who received PLUVICTO® for castration-sensitive prostate cancer are still eligible provided treatment was completed ≥ 42 days prior to start of study treatment.
  • Use of investigational agents for the treatment of prostate cancer ≤ 28 days of start of study treatment.
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  • Prior treatment with a PARP inhibitor.
  • Concurrent treatment with crizotinib.
  • Prior platinum-based chemotherapy for the treatment of prostate cancer.
  • Current or planned use of potent P-gp inhibitors within 7 days prior to randomization. The P-gp inhibitors include: amiodarone, carvedilol, clarithromycin, cobicistat, dronedarone, erythromycin, glecaprevir/pibrentasvir, indinavir, itraconazole, ketoconazole, lapatinib, lopinavir, propafenone, quinidine, ranolazine, ritonavir, saquinavir, sofosbuvir/velpatasvir/voxilaprevir, telaprevir, tipranavir, valspodar, and verapamil.
  • Participants treated within 7 days of randomization with any medication that may result in a drug-drug interaction with study treatment, including strong CYP2C8 inhibitors or inducers; strong or moderate CYP3A4 inducers or substrates of CYP3A4, CYP2C9, or CYP2C19 with a narrow therapeutic index unless considered medically necessary to treat a life-threatening condition. Examples include, but are not limited to, clopidogrel, gemfibrozil, rifampin, carbamazepine, phenobarbital, phenytoin, rifabutin, rifapentine, St. John's Wort, bosentan, efavirenz, etravirine, modafinil, nafcillin, alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus, warfarin, and S-mephenytoin.
  • Use of hormonal agents with known or potential anti-tumor activity against prostate cancer within 28 days prior to the start of study treatment is prohibited. This includes, but is not limited to, 5-alpha reductase inhibitors, androgens such as testosterone, cyproterone acetate, progestational agents, estrogens, and diethylstilbestrol.
  • Use of herbal products, nutritional supplements, or alternative therapies that may decrease PSA levels within 28 days prior to initiation of study treatment or plans to initiate treatment with these products/alternative therapies during the entire duration of the study. Examples include but are not limited to, saw palmetto, selenium supplements, and grape seed extract.
  • Participants receiving a blood transfusion within 14 days of randomization are not eligible.
  • History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke, significant brain trauma). Also, history of loss of consciousness or transient ischemic attack within 12 months of randomization.
  • Medical conditions such as uncontrolled hypertension as indicated by a resting systolic blood pressure > 160 mm Hg or diastolic blood pressure > 90 mm Hg at screening, uncontrolled diabetes mellitus, and cardiac disease that would preclude participation, as determined by the investigator.
  • Untreated known or suspected brain metastases or spinal cord compression or clinically significant malignant epidural disease.
  • Use of any prohibited concomitant medications (Appendix C: Medications with the Potential for Drug-Drug Interactions) within 28 days before first dose of study treatment unless otherwise specified as 7 days.
  • Grade >2 treatment-related toxicity from prior therapy except alopecia or peripheral neuropathy.
  • Known allergy to any of the compounds under investigation.
  • Any other condition which, in the opinion of the Investigator, would preclude participation in this trial.

Trial locations and contacts

8 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sarah Wise contact

215-380-9051

wises@mskcc.org

8 sites in 1 country

United States8 sites, 8 recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

    Alicia Morgans, MD, 857-215-1605, aliciak_morgans@dfci.harvard.edu

    Recruiting

  • City of Hope

    Duarte, California, 91010

    Erin Morones, 626-218-9708, emorones@coh.org

    Recruiting

  • UCSD Moores Cancer Center

    La Jolla, California, 92037

    Rana McKay, MD, 858-822-6185, rmckay@health.ucsd.edu

    Rana McKay, MD

    Recruiting

  • University of Wisconsin Carbone Cancer Center-Madison

    Madison, Wisconsin, 53705

    UWCCC Clinical Trials Navigation Team, 608-262-0439, clinicaltrials@cancer.wisc.edu

    Recruiting

  • Masonic Cancer Center

    Minneapolis, Minnesota, 55455

    Masonic Cancer Nurse Line, ccinfo@umn.edu

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Karen Autio, MD, 646-422-4632, autiok@mskcc.org

    Recruiting

  • Abramson Cancer Center of the University of Pennsylvania, Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Alex Torres, 267-496-7621, alexandra.torres@pennmedicine.upenn.edu

    Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

    Steven Blinka, MD, sblinka@fredhutch.org

    Lara Wahid, lwahid@fredhutch.org

    Recruiting

Other trials in United States

About this study

Official title: A Randomized Open-label Phase 2 Study of TALazoparib With or Without ENzaluTamide in Patients With Metastatic Castration-Resistant Prostate Cancer and HRR Mutations After Progression on Abiraterone Acetate or Darolutamide

The purpose of this study is to find out whether talazoparib in combination with enzalutamide or talazoparib alone delays cancer progression in people with metastatic castration-resistant prostate cancer (mCRPC) who have homologous recombination repair (HRR) mutations and have previously received abiraterone acetate or darolutamide

Being tested
Talazoparib with enzalutamide, Talazoparib
Keywords
talazoparib, enzalutamide, PARP inhibitor, TALENT, androgen receptor signaling inhibitor (ARSI), Prostate Cancer Clinical Trials Consortium, LLC (PCCTC), c24-349
Medical subject headings
Prostatic Neoplasms, Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Talazoparib with enzalutamideDrug

    Also called Talzenna, Xtandi

    Talazoparib (0.5 mg PO QD) and enzalutamide (160 mg PO QD) will be administered in continuous 28-day cycles.

  • TalazoparibDrug

    Also called Talzenna

    Talazoparib (1 mg PO QD) will be administered in continuous 28-day cycles.

Study groups in NCT06844383
Study groupRoleWhat they receive
Arm AActive comparatorTalazoparib (0.5 mg PO QD) and enzalutamide (160 mg PO QD) will be administered in continuous 28-day cycles.
Receives: Drug: Talazoparib with enzalutamide
Arm BExperimentalTalazoparib (1 mg PO QD) will be administered in continuous 28-day cycles.
Receives: Drug: Talazoparib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. radiographic progression free survival (rPFS)

    To compare the efficacy of talazoparib + enzalutamide to talazoparib alone as measured by rPFS as assessed by the Investigator.

    Measured: From treatment initiation until documented disease progression, death, lost to follow-up, withdrawal, administrative censoring at the time of final analysis, assessed at approximately 42 months from the start of enrollment.

Secondary outcomes (7)

  1. Time to PSA50

    To compare the efficacy of talazoparib + enzalutamide to talazoparib alone as measured by time to prostate specific antigen (PSA) ≥ 50% decline, summarized using median time-to-event and landmark response rates at 9 and 12 months.

    Measured: Time from treatment initiation until observed PSA50, assessed at approximately 42 months from the start of enrollment.

  2. Time to PSA Progression

    To compare the efficacy of talazoparib + enzalutamide to talazoparib alone as measured by time to PSA progression.

    Measured: From treatment initiation until documented PSA progression, assessed at approximately 42 months from the start of enrollment.

  3. Quality of Life (QoL) by Functional Assessment of Cancer Therapy-Prostate (FACT-P)

    Overall QoL measured by FACT-P. Scales: FACT-P Total score (range 0-156), FACT-General (G) Total score (range 0-108), FACT-P Trial Outcome Index (TOI) score (range 0-104). The higher the score, the better the QOL.

    Measured: From prior to treatment initiation (screening) until treatment discontinuation, assessed at approximately 42 months from the start of enrollment.

  4. Quality of Life (QoL) by Functional Assessment of Cancer Intervention Therapy-Fatigue Scale (FACIT-Fatigue)

    Fatigue measured by FACIT-Fatigue. Scales: FACIT-F Total score (range 0-160), FACT-General (G) Total score (range 0-108), FACIT-F Trial Outcome Index (TOI) score (range 0-108). The higher the score, the better the QOL.

    Measured: From prior to treatment initiation (screening) until treatment discontinuation, assessed at approximately 42 months from the start of enrollment.

  5. Quality of Life (QoL) by Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)

    Cognitive function measured by FACT-Cog. Subscales: Perceived Cognitive Impairments (CogPCI) score (range 0-72), Impact of Perceived Cognitive Impairments on Quality of Life (CogQOL) score (range 0-16), Comments from Others (CogOth) score (range 0-16), Perceived Cognitive Abilities (CogPCA) score (range 0-28). The higher the score, the better the QOL.

    Measured: From prior to treatment initiation (screening) until treatment discontinuation, assessed at approximately 42 months from the start of enrollment.

  6. Adverse Events (AE)

    Evaluate AE occurrence according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 to confirm safety.

    Measured: From treatment initiation through follow up, up to 12 months from end of treatment, assessed at approximately 42 months from the start of enrollment.

  7. Overall Survival (OS)

    To compare the efficacy of talazoparib + enzalutamide to talazoparib alone as measured by OS.

    Measured: From treatment initiation until death, lost to follow-up, withdrawal, administrative censoring at the time of final analysis, assessed at approximately 42 months from the start of enrollment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2025
  2. Study start4 May 2026
  3. Primary completionMar 2029 (estimated)
  4. Study completionMar 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
126 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06844383
Sponsor's protocol ID
c24-349
Acronym
TALENT
Status last verified
Aug 2026
First submitted
7 Feb 2025
Last updated
21 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The Prostate Cancer Clinical Trials Consortium, LLC supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: pcctc@mskcc.org.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Talazoparib with enzalutamide and Talazoparib in people with Prostate Cancer (Adenocarcinoma) and mCRPC (Metastatic Castration-resistant Prostate Cancer), run by Prostate Cancer Clinical Trials Consortium at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sarah Wise (215-380-9051, wises@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

radiographic progression free survival (rPFS) (time frame: From treatment initiation until documented disease progression, death, lost to follow-up, withdrawal, administrative censoring at the time of final analysis, assessed at approximately 42 months from the start of enrollment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06844383.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.

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