599 Participants Needed

Talazoparib + Enzalutamide for Metastatic Prostate Cancer

Recruiting at 364 trial locations
PC
Overseen ByPfizer CT.gov Call Center
Age: 18+
Sex: Male
Trial Phase: Phase 3
Sponsor: Pfizer
Must be taking: GnRH agonists/antagonists
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

The purpose of the study is to evaluate the safety and efficacy of talazoparib in combination with enzalutamide compared with placebo in combination with enzalutamide in participants with DDR-deficient mCSPC.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, ongoing ADT (androgen deprivation therapy) with a GnRH agonist or antagonist must continue throughout the study. It's best to discuss your specific medications with the study team.

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

Research shows that Talazoparib, when combined with Enzalutamide, has potential benefits for treating metastatic prostate cancer, especially in patients with specific genetic changes. Enzalutamide alone has already been proven to improve survival in men with metastatic hormone-sensitive prostate cancer.12345

Is the combination of Talazoparib and Enzalutamide safe for humans?

Talazoparib has shown a manageable safety profile in men with metastatic prostate cancer, and Enzalutamide is an FDA-approved drug for this condition, indicating it is generally considered safe for use in humans.12367

What makes the drug combination of talazoparib and enzalutamide unique for treating metastatic prostate cancer?

The combination of talazoparib and enzalutamide is unique because it pairs a PARP inhibitor (talazoparib) with an androgen receptor-targeted therapy (enzalutamide), which may improve treatment effectiveness for metastatic prostate cancer, especially in patients with specific genetic alterations related to DNA repair.12346

Research Team

PC

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

Men 18+ (varies by country) with metastatic prostate cancer and confirmed DDR gene mutation. They must have adequate organ function, no prior docetaxel treatment for mCSPC, and agree to contraception use. Exclusions include previous treatments with certain drugs, active COVID-19 infection, history of seizures or major surgery within the last month.

Inclusion Criteria

I have not been treated with docetaxel for my prostate cancer.
I am willing and able to follow all study requirements.
My organs are functioning well enough for treatment.
See 15 more

Exclusion Criteria

I have a history of MDS, AML, or another cancer, with some exceptions.
You have not participated in any experimental medical treatments for at least four weeks before the study.
I have a serious heart condition.
See 16 more

Timeline

Prescreening

Initial assessment to determine potential eligibility for the trial

2-4 weeks

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Double-blind Treatment

Participants receive either talazoparib with enzalutamide or placebo with enzalutamide

Up to 3 years

Safety Follow-up

Participants are monitored for safety after treatment

4 weeks

Long-term Follow-up

Participants are monitored for long-term outcomes and survival

Up to 4 years

Treatment Details

Interventions

  • Enzalutamide
  • Talazoparib
Trial OverviewThe trial is testing the effectiveness of talazoparib combined with enzalutamide versus a placebo plus enzalutamide in men with DDR-deficient metastatic prostate cancer. The goal is to see if talazoparib can improve outcomes when added to standard therapy.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1Experimental Treatment1 Intervention
Talazoparib plus enzalutamide
Group II: Arm 2Active Control1 Intervention
Placebo plus enzalutamide

Enzalutamide is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸
Approved in United States as Xtandi for:
  • Metastatic castration-resistant prostate cancer (mCRPC)
  • Non-metastatic castration-resistant prostate cancer (nmCRPC)
🇪🇺
Approved in European Union as Xtandi for:
  • Metastatic castration-resistant prostate cancer (mCRPC)
  • Non-metastatic castration-resistant prostate cancer (nmCRPC)
🇨🇦
Approved in Canada as Xtandi for:
  • Metastatic castration-resistant prostate cancer (mCRPC)
  • Non-metastatic castration-resistant prostate cancer (nmCRPC)
🇯🇵
Approved in Japan as Xtandi for:
  • Metastatic castration-resistant prostate cancer (mCRPC)
  • Non-metastatic castration-resistant prostate cancer (nmCRPC)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Pfizer

Lead 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

Astellas Pharma Inc

Industry Sponsor

Trials
700
Recruited
236,000+
Headquarters
Tokyo, Japan
Top Products
- Xtandi (enzalutamide) for prostate cancer, - Xospata (gilteritinib) for AML, - Padcev (enfortumab vedotin) for bladder cancer, - Prograf (tacrolimus) for organ rejection prevention
Tadaaki Taniguchi profile image

Tadaaki Taniguchi

Astellas Pharma Inc

Chief Medical Officer since 2023

MD, PhD

Naoki Okamura profile image

Naoki Okamura

Astellas Pharma Inc

Chief Executive Officer since 2023

University of Tokyo, Faculty of Pharmacy

Findings from Research

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]
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]
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]

References

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]
TALAPRO-3 clinical trial protocol: phase III study of talazoparib plus enzalutamide in metastatic castration-sensitive prostate cancer. [2023]
Patient-reported Outcomes in Men with Metastatic Castration-resistant Prostate Cancer Harboring DNA Damage Response Alterations Treated with Talazoparib: Results from TALAPRO-1. [2023]
Talazoparib plus enzalutamide in metastatic castration-resistant prostate cancer: TALAPRO-2 phase III study design. [2022]
Enzalutamide Bests Older NSAAs in mHSPC. [2021]
Talazoparib, a Poly(ADP-ribose) Polymerase Inhibitor, for Metastatic Castration-resistant Prostate Cancer and DNA Damage Response Alterations: TALAPRO-1 Safety Analyses. [2023]
Enzalutamide for patients with metastatic castration-resistant prostate cancer. [2020]