1054 Participants Needed

Talazoparib + Enzalutamide for Prostate Cancer

(TALAPRO-2 Trial)

Recruiting at 412 trial locations
PC
Overseen ByPfizer CT.gov Call Center
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

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot use potent P-gp inhibitors within 7 days before starting the trial. It's best to discuss your current medications with the trial team.

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

Research shows that combining Talazoparib, a PARP inhibitor, with Enzalutamide, an androgen receptor blocker, may improve treatment outcomes for men with metastatic castration-resistant prostate cancer. This combination has shown potential in delaying disease progression compared to using Enzalutamide alone.12345

Is the combination of Talazoparib and Enzalutamide safe for humans?

Enzalutamide, used for prostate cancer, has been generally well-tolerated in clinical trials, but some patients have experienced side effects like severe thrombocytopenia (low platelet count) and seizures. In Japanese patients, certain side effects may occur more frequently due to higher drug concentrations in the blood.678910

How is the drug combination of talazoparib and enzalutamide unique for prostate cancer treatment?

The combination of talazoparib and enzalutamide is unique because it targets prostate cancer by combining a PARP inhibitor (talazoparib) with an androgen receptor inhibitor (enzalutamide), potentially improving outcomes for patients with specific genetic alterations related to DNA repair.123411

What is the purpose of this trial?

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.

Research Team

PC

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

Men with advanced prostate cancer that's resistant to hormone therapy (mCRPC), not severely symptomatic, and have a life expectancy of at least 12 months. Participants must have rising PSA levels, be able to swallow pills, consent to genetic testing, and use effective contraception. Excluded are those who've had seizures, significant heart disease, recent opioid treatment for cancer pain or certain prior cancer treatments.

Inclusion Criteria

I have undergone treatment to lower my testosterone levels below 50 ng/dL.
Agree to specific contraception measures during and after the study treatment
Life expectancy ≥ 12 months as assessed by the investigator
See 11 more

Exclusion Criteria

I have started treatment for prostate cancer before it spread.
I have a serious heart condition.
My cancer spread is limited to lymph nodes below where my aorta splits.
See 17 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety and PK Run-in

Open-label, non-randomized study to confirm the starting dose of talazoparib in combination with enzalutamide through assessment of target safety events and pharmacokinetics

66 days

Treatment

Randomized, double-blind, placebo-controlled study comparing talazoparib plus enzalutamide vs. placebo plus enzalutamide

Up to 42 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 days after the last dose

Treatment Details

Interventions

  • Enzalutamide
  • Talazoparib
Trial Overview The trial is examining if adding Talazoparib (a PARP inhibitor) to Enzalutamide (an anti-androgen drug) improves outcomes compared to using Enzalutamide alone in men with mCRPC. The study measures how long patients live without the disease getting worse.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Combination armExperimental Treatment1 Intervention
Talazoparib plus enzalutamide
Group II: Monotherapy armActive Control1 Intervention
Ezalutamide plus placebo

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]
Talazoparib plus enzalutamide in men with first-line metastatic castration-resistant prostate cancer (TALAPRO-2): a randomised, placebo-controlled, phase 3 trial. [2023]
Efficacy and Safety of Enzalutamide in a Real-World Cohort of Japanese Patients With Castration-resistant Prostate Cancer. [2021]
Enzalutamide-induced severe thrombocytopenia complicated by a seizure in a 76-year-old man with castration-resistant prostate cancer. [2022]
Managing lines of therapy in castration-resistant prostate cancer: real-life snapshot from a multicenter cohort. [2021]
Enzalutamide: a novel anti-androgen with prolonged survival rate in CRPC patients. [2021]
Molecular characterization of enzalutamide-treated bone metastatic castration-resistant prostate cancer. [2022]
Talazoparib, a Poly(ADP-ribose) Polymerase Inhibitor, for Metastatic Castration-resistant Prostate Cancer and DNA Damage Response Alterations: TALAPRO-1 Safety Analyses. [2023]
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