Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Immune System Diseases

Prostatic Neoplasms

Hypersensitivity

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Antineoplastic Agents

Hormones

Talazoparib

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Patients will receive enzalutamide capsules orally once daily continuously (160 mg) in addition to standard ADT (unless surgical castration).

Patients will receive enzalutamide capsules 160 mg in combination with talazoparib (PF-06944076) capsules 0.5 mg, both orally daily and continuously in 28-day cycle, in addition to standard ADT (unless surgical castration).

Enzalutamide capsules orally once daily and continuously (160 mg) in 28-day cycles (every four weeks)

Enzalutamide

Talazoparib capsules orally once daily and continuously (0.5 mg) in 28-day cycles (every four weeks)

Joaquin Mateo

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-naïve prostate cancer (mHNPC)

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).

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

A Randomized Phase II Trial to Evaluate the Antitumor Activity of Enzalutamide and Talazoparib (PF-06944076) for the Treatment of Metastatic Hormone-naïve Prostate Cancer

The primary efficacy endpoint for the study is the PSA-CR. The PSA-CR is defined as the percentage of patients with PSA \< 0.2 ng/mL divided by the number of patients in the analysis set.

PSA-CR is defined as the number of patients with PSA \<0.2 ng/mL from randomization to Cycle 7 Day 1 therapy divided by the number of patients in the analysis set.

PSA response is defined as the number of patients with PSA \<0.4 ng/mL from randomization to 7- or 12-months therapy divided by the number of patients in the analysis set

TCP is defined as the time from randomization to clinical progression, based on progression in bone as per 2+2 rule, progression per RECIST criteria v1.1. or clinical deterioration due to cancer per investigator's opinion.

PSA-PD in accordance with PCWG3 criteria, is defined as the time from randomization to PSA progression.

PSA-PFS in accordance with based on Prostate Cancer Working Group 3 (PCWG3) criteria (PSA ≥ 25% and ≥ 2 ng/mL from nadir confirmed by a second value obtained 3 or more weeks later).

PFS is defined as the time from randomization to radiological progression based on progression in bone as per 2+2 rule or progression per RECIST criteria v1.1.

TTCR prostate cancer is defined as the time from randomization to PSA progression in accordance with PCWG3 criteria or clinical progression, whichever occurred first.

OS is defined as the time from randomizatiom date to date of death due to any cause or the last date the patient was known to be alive.

Incidence of prespecified AEs as per National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) v.5.0, change from baseline in targeted vital signs, and change from baseline in targeted clinical laboratory test results.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Enzalutamide Plus Talazoparib for the Treatment of Hormone Sensitive Prostate Cancer (ZZ-First)	NCT04332744	Metastatic Pros...	Enzalutamide Talazoparib	18 Years -	MedSIR
Enzalutamide Plus Talazoparib for the Treatment of Hormone Sensitive Prostate Cancer (ZZ-First)	NCT04332744	Metastatic Pros...	Enzalutamide Talazoparib	18 Years -	MedSIR

Spots Global Cancer Trial Database for mhnpc

Every month we try and update this database with for mhnpc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for mhnpc

Every month we try and update this database with for mhnpc cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for mhnpc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.