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Antiandrogen

Talazoparib + Enzalutamide for Prostate Cancer (TALAPRO-2 Trial)

Q: Has the FDA okayed Talazoparib in conjunction with enzalutamide?

<p>Talazoparib with <a href="https://www.withpower.com/clinical-trials/enzalutamide">enzalutamide</a>'s safety has been backed by multiple rounds of clinical data, giving it a score of 3.</p>

Phase 3

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Surgically or medically castrated, with serum testosterone ≤ 50 ng/dL (≤ 1.73 nmol/L) at screening

Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 47 months

Awards & highlights

TALAPRO-2 Trial Summary

This trial looks at whether adding the drug talazoparib to the drug enzalutamide improves progression-free survival in men with metastatic castration-resistant prostate cancer.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Talazoparib may cause blood cell count changes leading to anemia or infection risk increase; fatigue; nausea; digestive issues; and rare but serious effects on the lungs or kidneys. Enzalutamide can cause fatigue, hot flashes, high blood pressure and rarely seizures.

TALAPRO-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have undergone treatment to lower my testosterone levels below 50 ng/dL.

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I am fully active or can carry out light work.

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My prostate cancer is confirmed without specific aggressive features.

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I can swallow pills and have no allergies to medications I'm aware of.

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My cancer has worsened despite hormone therapy.

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My prostate cancer has spread, but I have little to no pain.

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My cancer has spread to my bones or soft tissues, confirmed by scans.

TALAPRO-2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 47 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 47 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 47 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

BICR Assessed rPFS Per RECIST 1.1 in Patients With DDR Deficiencies - Part 2

Blinded Independent Central Review (BICR) Assessed Radiographic Progression-Free Survival (rPFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for All-Comers - Part 2 Cohort 1

Number of Participants With All-Causality Clustered Treatment-Emergent Cytopenias by PT and Max CTCAE Grade Occuring Anytime After Dosing - Part 1

+5 more

Secondary outcome measures

Duration of soft tissue response (part 2) in unselected patients and in patients harboring DDR deficiencies

Incidence of adverse events (part 1 and 2)

Objective response in measurable soft tissue disease (part 2) in unselected patients and in patients harboring DDR deficiencies

+17 more

TALAPRO-2 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Combination armExperimental Treatment1 Intervention

Talazoparib plus enzalutamide

Group II: Monotherapy armActive Control1 Intervention

Ezalutamide plus placebo

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Astellas Pharma IncIndustry Sponsor

690 Previous Clinical Trials

230,985 Total Patients Enrolled

36 Trials studying Prostate Cancer

8,642 Patients Enrolled for Prostate Cancer

PfizerLead Sponsor

4,567 Previous Clinical Trials

10,910,819 Total Patients Enrolled

42 Trials studying Prostate Cancer

12,369 Patients Enrolled for Prostate Cancer

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,474 Previous Clinical Trials

8,091,987 Total Patients Enrolled

8 Trials studying Prostate Cancer

3,418 Patients Enrolled for Prostate Cancer

Media Library

Enzalutamide (Antiandrogen) Clinical Trial Eligibility Overview. Trial Name: NCT03395197 — Phase 3

Prostate Cancer Research Study Groups: Combination arm, Monotherapy arm

Prostate Cancer Clinical Trial 2023: Enzalutamide Highlights & Side Effects. Trial Name: NCT03395197 — Phase 3

Enzalutamide (Antiandrogen) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03395197 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial being run in more than one state?

"Eligible patients can enrol at 100 different trial sites, some of which include Piedmont Cancer Institute in Fayetteville, Rio Grande Urology, P.A. in El Paso, and University of Utah, Huntsman Cancer Institute in Salt Lake City."

Answered by AI

Are people currently being signed up for this experiment?

"Unfortunately, this study is not currently seeking new participants. Though, it's worth noting that there are 9 other clinical trials testing treatments for mcrpc and 160 studies involving Talazoparib with enzalutamide that are open to enrolling patients."

Answered by AI

Has the FDA okayed Talazoparib in conjunction with enzalutamide?

"Talazoparib with enzalutamide's safety has been backed by multiple rounds of clinical data, giving it a score of 3."

Answered by AI

Could you please disclose how many people are participating in this experiment?

"This clinical trial is no longer recruiting patients. Originally posted on December 18th, 2017 and last updated on October 7th, 2022; individuals looking for other studies may be interested to know that there are 9 clinical trials actively enrolling participants with mcrpc and 160 studies for Talazoparib with enzalutamide currently searching for patients."

Answered by AI

Is Talazoparib with enzalutamide a common treatment combination?

"Currently, there are a total of 160 ongoing trials studying the efficacy of Talazoparib with enzalutamide. This includes 31 Phase 3 clinical trials. The majority of these studies taking place in Singapore and Oregon; however, there are 7338 locations running trials for Talazoparib with enzalutamide across the globe."

Answered by AI

What are the goals that this clinical trial is hoping to achieve?

"The goal of this medical trial is to assess radiographic PFS in unselected patients and in patients with DDR deficiencies. Secondary objectives include time to first symptomatic skeletal event (in unselected patients and in patients with DDR deficiencies), pharmacokinetic assessment of enzalutamide, and incidence of adverse events."

Answered by AI

Recent research and studies

Future OncologyJournal

Talazoparib Plus Enzalutamide in Metastatic Castration-resistant Prostate Cancer: TALAPRO-2 Phase III Study Design

Agarwal, Neeraj, Arun Azad, Neal D Shore, Joan Carles, Andre P Fay, Curtis Dunshee, Lawrence Ivan Karsh, et al.. 2022. “Talazoparib Plus Enzalutamide in Metastatic Castration-resistant Prostate Cancer: TALAPRO-2 Phase III Study Design”. Future Oncology. Future Medicine Ltd. doi:10.2217/fon-2021-0811.

clinicaltrials.govStudy

Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC

2017. "Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03395197.

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