Prostate Cancer study: Talazoparib
Official title A Study of Talazoparib With or Without Enzalutamide in People With Prostate Cancer Who Have Previously Received Abiraterone Acetate or Darolutamide
ClinicalTrials.gov ID: NCT06844383
What this study is testing
What is Talazoparib with enzalutamide?
An investigational oral combination being studied as a potential treatment for metastatic castration‑resistant prostate cancer with HRR mutations. It is designed to block DNA repair (talazoparib, a PARP inhibitor) and block androgen signaling (enzalutamide, an androgen‑receptor inhibitor).
Also referred to as Talzenna, Xtandi.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out whether talazoparib, either by itself or together with enzalutamide, can delay disease progression in men with metastatic castration‑resistant prostate cancer who have homologous recombination repair gene mutations.
- Who it's for
- Men with metastatic castration‑resistant prostate cancer who have HRR gene mutations and have already been treated with abiraterone acetate or darolutamide.
- What's involved
- Participants will take talazoparib, and some will also take enzalutamide, with regular clinic visits for safety checks, blood tests, and imaging to monitor the cancer.
- Time commitment
- The trial lasts several months, with visits typically every few weeks to a month for medication dispensing and assessments.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Willing and able to provide, or have a legally authorized representative provide, written informed consent and privacy authorization for the release...
- Participants ≥ 18 years of age.
- Are willing to be assigned by chance 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.
You likely can't join if
- 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...
- 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...
- Participants who received PLUVICTO® for castration-sensitive prostate cancer are still eligible provided treatment was completed ≥ 42 days prior to...
- Use of investigational agents for the treatment of prostate cancer ≤ 28 days of start of study treatment.
See the full eligibility criteria
Who can 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.
- Participants ≥ 18 years of age.
- Are willing to be assigned by chance 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.
- 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...
- 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...
- Unequivocal prostate-specific membrane antigen (PSMA) positron emission tomography (PET) only defined metastatic disease with negative conventional imaging.
- 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...
- PSA progression defined as 2 rising PSA levels, above an initial reference value, taken with a minimum of a 1-week interval.
- 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...
- Eastern Cooperative Oncology Group (ECOG) status of ≤2 (Appendix A: Performance Status Criteria).
- 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...
What rules you out
- 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...
- 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.
- 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...
- 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
- 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.
- 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...
- 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).
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Duarte, California, United States
- La Jolla, California, United States
- Boston, Massachusetts, United States
- Minneapolis, Minnesota, United States
- New York, New York, United States
- Philadelphia, Pennsylvania, United States
- Seattle, Washington, United States
- Madison, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Duarte, California, United States; La Jolla, California, United States; Boston, Massachusetts, United States; Minneapolis, Minnesota, United States; New York, New York, United States; Philadelphia, Pennsylvania, United States and 2 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.