Enzalutamide Plus Talazoparib for the Treatment of Hormone Sensitive Prostate Cancer (ZZ-First)

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    54
  • sponsor
    MedSIR
Updated on 30 May 2021
ct scan
platelet count
MRI
gilbert's syndrome
metastasis
liver metastasis
bone scan
bone metastases
enzalutamide
adenocarcinoma
bisphosphonate
adenocarcinoma of prostate

Summary

This is a multicenter, open-label, randomized, two-arm, phase II clinical trial to evaluate the efficacy and safety of talazoparib (PF-06944076) in combination with enzalutamide in patients with metastatic hormone-nave prostate cancer (mHNPC)

Description

Men age 18 years with high-volume mHNPC that are not candidates for curative intent and have not received previous systemic treatment with any other agent for unresectable locally advanced or mHNPC.

After signing ICF and confirm eligibility, patients will start treatment with enzalutamide in addition to standard ADT. After 2 cycles of enzalutamide-containing regimen, patients will be randomized in a 1:2 ratio to:

Cohort A - Enzalutamide 160 mg orally daily continuously; Cohort B - Enzalutamide 160 mg in combination with talazoparib (PF-06944076) 0.5 mg, both orally daily and continuously in 28-day cycles.

In either arm, patients will be requested to continue ADT throughout trial participation (unless surgical castration).

Randomization will be stratified based on HR gene alterations (presence versus absence/unknown) detected in the baseline biopsy.

Patients will receive treatment until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason.

Patients discontinuing the study treatment period will enter a post-treatment follow-up period during which survival and at least the first two new anti-cancer therapies will be collected every six months ( 14 days) from the last dose of investigational product until the end of study (EoS).

Details
Condition Metastatic Prostate Cancer, Prostate Cancer Metastatic
Treatment Enzalutamide, Talazoparib
Clinical Study IdentifierNCT04332744
SponsorMedSIR
Last Modified on30 May 2021

Eligibility

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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