126 Participants Needed

Talazoparib ± Enzalutamide for Prostate Cancer

(TALENT Trial)

Recruiting at 1 trial location
SW
Overseen BySarah Wise
Age: 18+
Sex: Male
Trial Phase: Phase 2
Sponsor: Prostate Cancer Clinical Trials Consortium
Must be taking: Gonadotropin-releasing hormone
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires stopping certain medications before participation. You must not use potent P-gp inhibitors, strong CYP2C8 inhibitors, strong CYP3A4 inducers, or certain hormonal agents within specified periods before starting the study. Check with the trial team to see if your current medications are on the list.

What data supports the effectiveness of the drug combination Talazoparib and Enzalutamide for prostate cancer?

Research shows that Talazoparib, when used with Enzalutamide, has potential benefits for men with metastatic castration-resistant prostate cancer, especially those with specific genetic changes related to DNA repair. This combination has shown promise in improving the time patients live without their cancer getting worse.12345

Is Talazoparib plus Enzalutamide safe for humans?

Talazoparib has shown a manageable safety profile in men with metastatic castration-resistant prostate cancer, and studies are ongoing to evaluate the safety of combining it with Enzalutamide.12456

How is the drug Talazoparib different from other prostate cancer treatments?

Talazoparib is unique because it is a PARP inhibitor that targets cancer cells with specific DNA repair gene alterations, and when combined with enzalutamide, it may enhance treatment effectiveness for prostate cancer that has spread and is resistant to standard hormone therapy.12345

Research Team

AM

Alicia Morgans, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

Men over 18 with advanced prostate cancer that's resistant to castration and has specific genetic mutations. They must have had prior treatment with abiraterone, be able to swallow pills, have good performance status (ECOG ≤1), normal organ function, and agree to contraception. Excluded are those with allergies to the drugs tested, other active cancers needing treatment within 3 years, seizure history or risks, certain medical conditions or treatments that could interfere.

Inclusion Criteria

I can swallow pills whole.
I am fully active and can carry on all pre-disease activities without restriction.
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. Privacy authorization may be either included in the informed consent or obtained separately.
See 10 more

Exclusion Criteria

Known allergy to any of the compounds under investigation.
I don't have any other active cancers or any diagnosed in the last 3 years needing treatment.
Use of investigational agents for the treatment of prostate cancer within 4 weeks of the start of study treatment.
See 15 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive talazoparib with or without enzalutamide in continuous 28-day cycles

42 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

  • Enzalutamide
  • Talazoparib
Trial Overview The trial is testing whether talazoparib alone or combined with enzalutamide can slow down cancer growth in men whose prostate cancer has spread and is not responding to hormone therapy anymore. These patients also have genetic changes making their cancer potentially more sensitive to these drugs.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm BExperimental Treatment1 Intervention
Talazoparib (1 mg PO QD) will be administered in continuous 28-day cycles.
Group II: Arm AActive Control1 Intervention
Talazoparib (0.5 mg PO QD) and enzalutamide (160 mg PO QD) will be administered in continuous 28-day cycles.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Prostate Cancer Clinical Trials Consortium

Lead Sponsor

Trials
12
Recruited
7,400+

Pfizer

Industry Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Dana-Farber Cancer Institute

Collaborator

Trials
1,128
Recruited
382,000+

Memorial Sloan Kettering Cancer Center

Collaborator

Trials
1,998
Recruited
602,000+

Findings from Research

In the TALAPRO-1 study involving 97 men with metastatic castration-resistant prostate cancer (mCRPC), talazoparib significantly improved health-related quality of life (HRQoL) and reduced pain levels, particularly in patients with BRCA1/2 mutations.
The study found that 84% of all patients and 83% of those with BRCA1/2 mutations did not experience a deterioration in worst pain after 12 months of treatment, indicating a high probability of maintaining pain relief while receiving talazoparib.
Patient-reported Outcomes in Men with Metastatic Castration-resistant Prostate Cancer Harboring DNA Damage Response Alterations Treated with Talazoparib: Results from TALAPRO-1.Saad, F., de Bono, J., Barthélémy, P., et al.[2023]
The TALAPRO-3 study is a phase III clinical trial designed to evaluate the effectiveness of combining talazoparib, a poly(ADP-ribose) polymerase inhibitor, with enzalutamide in patients with metastatic castration-sensitive prostate cancer (mCSPC) who have homologous recombination repair (HRR) gene alterations.
The primary goal of the study is to determine if this combination therapy can improve radiographic progression-free survival (rPFS) compared to enzalutamide alone, potentially offering a new treatment strategy for patients with specific genetic profiles.
TALAPRO-3 clinical trial protocol: phase III study of talazoparib plus enzalutamide in metastatic castration-sensitive prostate cancer.Agarwal, N., Saad, F., Azad, AA., et al.[2023]
The TALAPRO-2 trial is an ongoing study involving 1037 men with metastatic castration-resistant prostate cancer, testing the combination of talazoparib and enzalutamide to see if it improves survival without cancer progression compared to enzalutamide plus a placebo.
This trial aims to assess not only the efficacy of the drug combination but also the side effects experienced by participants, while also analyzing tumor DNA for faulty repair genes, which could provide insights into treatment responses.
Plain language summary of the design of the TALAPRO-2 study comparing talazoparib and enzalutamide versus enzalutamide and placebo in men with metastatic castration-resistant prostate cancer.Agarwal, N., Azad, A., Shore, ND., et al.[2022]

References

Patient-reported Outcomes in Men with Metastatic Castration-resistant Prostate Cancer Harboring DNA Damage Response Alterations Treated with Talazoparib: Results from TALAPRO-1. [2023]
TALAPRO-3 clinical trial protocol: phase III study of talazoparib plus enzalutamide in metastatic castration-sensitive prostate cancer. [2023]
Plain language summary of the design of the TALAPRO-2 study comparing talazoparib and enzalutamide versus enzalutamide and placebo in men with metastatic castration-resistant prostate cancer. [2022]
Talazoparib plus enzalutamide in metastatic castration-resistant prostate cancer: TALAPRO-2 phase III study design. [2022]
Talazoparib plus enzalutamide in men with first-line metastatic castration-resistant prostate cancer (TALAPRO-2): a randomised, placebo-controlled, phase 3 trial. [2023]
Talazoparib, a Poly(ADP-ribose) Polymerase Inhibitor, for Metastatic Castration-resistant Prostate Cancer and DNA Damage Response Alterations: TALAPRO-1 Safety Analyses. [2023]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security