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

talazoparib plus enzalutamide

Placebo plus enzalutamide

Pfizer CT.gov Call Center

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.

The study will have 5 periods: prescreening, screening, double-blind treatment, safety follow-up, and long-term follow-up.

Approximately 550 men with mCSPC will be randomized. Eligible participants will be randomly assigned to either of 2 treatment groups as follows:

* Talazoparib in combination with enzalutamide.
* Placebo capsules identical in appearance to talazoparib capsules in combination with enzalutamide.

Talazoparib or identical placebo treatment will be blinded. Enzalutamide (160 mg/day) will be open label. The dose of talazoparib/placebo to be given in combination with enzalutamide is 0.5 mg once daily. Participants with moderate renal impairment (eGFR 30-59 mL/min/1.73 m2 by the MDRD equation) at screening may be enrolled and the talazoparib/placebo dose will be 0.35 mg once daily.

Parallel: Participants are assigned to one of two or more groups in parallel for the duration of the study

Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC

TALAPRO-3: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, STUDY OF TALAZOPARIB WITH ENZALUTAMIDE VERSUS PLACEBO WITH ENZALUTAMIDE IN MEN WITH DDR GENE MUTATED METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

time from the date of randomization to first objective evidence of radiographic progression or death, whichever occurs first

time from randomization to death from any cause

proportion of patients with measurable soft tissue disease at baseline with objective response per RECIST 1.1

duration of responses in patients with measurable soft tissue disease at baseline per RECIST 1.1

proportion of patients with PSA response grater than or equal to 50%

Time from randomization to initiation of antineoplastic therapy

time from randomization to first symptomatic skeletal event (symptomatic fractures, spinal cord compression, surgery or radiation to the bone whichever is first)

time from randomization to opiate use for prostate cancer pain

AEs and SAEs incidence by type and severity (graded by NCI CTCAE version 4.03)

plasma concentrations of enzalutamide and its metabolite

change from baseline in patient-reported pain symptoms per Brief Pain Inventory Short Form (BPI-SF)

time to deterioration in patient-reported pain symptoms per Brief Pain Inventory Short Form (BPI-SF)

change from baseline in participant-reported general health status per EQ-5D-5L

change from baseline in patient-reported Global health status/QoL per EORTC QLQ-C30

time to definitive deterioration in patient-reported global health status/QoL per EORTC QLQ-C30

time to definitive deterioration in disease specific urinary symptoms per EORTC QLQ-PR25

Astellas Pharma Inc

Pfizer

Docetaxel

Patients with metachronous or de novo metastatic hormone/castration-sensitive PCa treated with ADT+ARSI or ADT+ARSI+docetaxel

Matteo Santoni

Matteo Santoni, MD, PhD

Study wants to explore real-world data in three distinct settings

* Patients with metachronous or de novo mCSPC treated with ADT+ARSI or ADT+ARSI+docetaxel _ARON-3S
* Patients receiving Lutetium-177 PSMA for mCRPC _ ARON-3Lu
* Patients treated with PARP inhibitors (alone or combined with ARSI) for CRPC _ ARON-3GEN

ARON-3 Study: International Multicentric Retrospective Study to Collect Global Experiences in the Treatment of Patients With Metastatic PCa

Statistical analysis of data obtained by medical charts related to disease metastatic sites, treatment performed and period of time from the start of treatment until the radiological progression disease

Statistical analysis of data obtained by medical charts related to lifestyle and concomitant medications

Hospital of Macerata

Medical Doctor, Principal Investigator

Abiraterone Acetate

Patients initiating novel hormonal therapy (abiraterone, apalutamide or enzalutamide) for mCSPC

Novel hormonal therapy

The purpose of this study is to learn about how long novel hormonal therapies are taken by men to treat mCSPC. Novel hormonal therapies in this study include study medicines abiraterone, apalutamide, and enzalutamide.

Prostate cancer is one of the most common cancers in men. The prostate is a gland in the male body that helps make semen. Metastatic cancer is a cancer that has spread to other parts of the body. Castration-sensitive prostate cancer means the cancer is being controlled by keeping the testosterone levels as low as would be expected if the testicles were removed by surgery.

This is a real-world study, not a clinical trial. This means that researchers will look at what happens when men receive the treatments prescribed by their own doctor as part of their usual healthcare treatment. In this study, researchers will use insurance claim information from Medicare claims data.

The study will include patients' information from the database for men who:

* Were identified to have mCSPC.
* Started treatment with novel hormonal therapy (index date) for mCSPC.
* Were 65 years of age or older one year before index date.

Men in this study will be taking novel hormonal therapy for treatment of their mCSPC. We will describe how long men take novel hormonal therapy. This study will use patient information from insurance claims. It will take information one year before start of novel hormonal treatment until the end of insurance period or until information is available.

A Study to Learn About Novel Hormonal Therapies in People With Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

Novel Hormonal Therapies (NHTs) for the Treatment of Metastatic Castration-sensitive Prostate Cancer (mCSPC) in the Medicare Population

Treatment duration will be defined as the time from the initiation of novel hormonal therapy (abiraterone, apalutamide, or enzalutamide) to the discontinuation date. Discontinuation will be defined as the earliest of 1) death, 2) last observed pharmacy claim plus days of supply associated with last claim, 3) day before the start of next line of therapy, or 4) end of data availability.

Anti-Inflammatory Agents

Reproductive Control Agents

Antiemetics

Neuroprotective Agents

Gastrointestinal Agents

Prednisone

Prednisolone

Leuprolide

Relugolix

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Tubulin Modulators

Antimitotic Agents

Glucocorticoids

Hormone Antagonists

Antineoplastic Agents, Hormonal

Protective Agents

Androgens

Androgen Antagonists

Participants will receive relugolix in combination with abiraterone plus a corticosteroid for 12 weeks during the study treatment period.

Participants will receive relugolix in combination with apalutamide for 12 weeks during the study treatment period.

Participants will receive relugolix in combination with docetaxel with or without prednisone for 12 weeks during the study treatment period.

(Part 1 and Part 3) Relugolix will be administered orally as a single 360-milligram (mg) loading dose of 3 x 120-mg tablets, followed by a 120-mg dose (1 x 120-mg tablets), taken once daily at approximately the same time each day.

(Part 2) Relugolix will be administered orally as a single 360-milligram (mg) loading dose of 3 x 120-mg tablets, followed by a 240-mg dose (2 x 120-mg tablets), taken once daily at approximately the same time each day.

Abiraterone acetate (1000 mg \[2 x 500-mg tablets\]) or fine-particle abiraterone acetate (500 mg \[4 x 125-mg tablets\]) will be administered orally once daily.

Abiraterone

(Part 1 only) For participants with mCSPC, a 5-mg dose of prednisone will be administered orally once daily, and for participants with mCRPC, a 5-mg dose of prednisone will be administered orally twice daily.

(Part 3 only) Prednisone 5 mg can be administered orally twice daily but is not required.

For participants with mCRPC taking fine-particle abiraterone acetate, methylprednisolone 4 mg will be administered orally twice daily.

Apalutamide 240 mg (4 x 60-mg tablets) will be administered orally once daily.

Apalutamide

Docetaxel 75 mg/m2 dose will be administered every 3 weeks as a 1-hour intravenous infusion.

Mike Ufer

This study is being conducted to assess the safety and tolerability of relugolix with other agents approved for use in combination with androgen deprivation therapy (ADT) for a 12-week treatment period and an additional 40-week safety extension period in men with prostate cancer, either metastatic castration-sensitive prostate cancer (mCSPC) or non-metastatic or metastatic castration-resistant prostate cancer (nmCRPC or mCRPC).

This is a three-part, open-label, parallel-cohort study to assess the safety and tolerability of relugolix as the ADT component in combination treatment with abiraterone acetate plus a corticosteroid in patients with mCSPC or mCRPC (Part 1), apalutamide in patients with mCSPC or nmCRPC (Part 2), or docetaxel with or without prednisone in patients with mCSPC or mCRPC (Part 3).

The study will consist of a 45-day screening period followed by a 12-week treatment period with one of the three combination treatments (Parts 1, 2, or 3). All participants are required to be currently or previously treated with a GnRH receptor antagonist (analog), leuprolide acetate or triptorelin, or a GnRH receptor antagonist, degarelix or relugolix, in combination with either abiraterone plus prednisone (Part 1), apalutamide (Part 2), or docetaxel (Part 3). The study consists of a 12-week primary study treatment period in which safety and tolerability, including assessment of vital sign measurements, ECGs, clinical laboratory tests and reporting of adverse events every 2 to 4 weeks, followed by a 40-week safety extension treatment period during which adverse events and changes to concomitant medications will be reported. The total treatment duration is 52 weeks.

Study of Relugolix in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer

A Phase 1, Three-Part, Open-Label, Parallel-Cohort Safety and Tolerability Study of Relugolix in Combination With Abiraterone Acetate Plus a Corticosteroid, Apalutamide, or Docetaxel With or Without Prednisone in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer

Sumitomo Pharma Switzerland GmbH

Carcinoma

Olaparib

Cytochrome P-450 Enzyme Inhibitors

Subjects will receive a regimen of Olaparib tablets 300 mg twice daily in combination with Abiraterone acetate 1000 mg plus Prednisone 5mg once daily until radiographic disease progression (assessed by the investigator according to RECIST1.1 and PCWG3) or intolerable adverse events (assessed by the investigator according to the actual clinical situation).

Lynparza (Olaparib tablets) 300 mg should be taken orally twice daily.

Olaparib tablet

Qingkeshu (Abiraterone acetate tablets) 1000 mg should be taken orally once daily.

Abiraterone acetate

Prednisone Tablets should be taken 5 mg once daily.

Prednisone tablet

Junlong Zhuang, MD

This is a single-center, single-arm, prospective study to assess the efficacy and safety of Olaparib combined with Abiraterone plus Prednisone in subjects with metastatic hormone sensitive prostate cancer (mHSPC) who carry deleterious germline or homologous recombination repair (HRR) mutations.

Olaparib is an oral, highly selective poly (ADP-ribose) polymerase (PARP) inhibitor that potently inhibits the activity of deoxyribonucleic acid repair polymerases. Abiraterone acetate (AA) is a prodrug of abiraterone that potently inhibits cytochrome P450c17, a key enzyme in androgen biosynthesis.

A total of 30 mHSPC subjects with HRR gene mutations that meet the criteria will be included in the study. Eligible subjects will receive oral Olaparib tablets 300 mg BID, combined with Abiraterone acetate 1000 mg QD plus Prednisone 5 mg, and the study will end when the primary endpoint radiographic progression-free survival (rPFS) data maturity reaches 60%. During the treatment and follow-up periods, all subjects will have regular visits to assess the efficacy and safety of Olaparib in combination with abiraterone acetate plus prednisone. Radiographic progression-free survival (rPFS), prostate-specific antigen response (PSA response rate), prostate-specific antigen progression-free survival (PSA-PFS), radiological objective response rate (ORR) and other indicators will be assessed and calculated.

The Study of Olaparib Combined With Abiraterone and Prednisone in mHSPC Patients With HRR Gene Mutation

A Single-center, Single-arm, Prospective Study to Investigate the Efficacy and Safety of Olaparib Combined With Abiraterone and Prednisone in mHSPC Patients With HRR Gene Mutation

An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment

Time from the start of study drug to radiographic progression, or death due to any cause, whichever occurs first.

PSA response is defined as a ≥ 50% decline in PSA from baseline PSA value. This PSA decline must be confirmed as sustained by a second PSA value obtained ≥ 3 weeks later.

PSA-PFS is defined as the time from the start of study drug to the first PSA progression or death due to any cause without progression. PSA progression is defined as a first PSA increase greater than or equal to 25% of baseline and ≥ 2 ng/ml and confirmed a second time after 3 or more weeks.

ORR is the percentage of patients with at least one visit response of Complete response (CR) or Partial response (PR), in their soft tissue disease assessed by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), in the absence of progression on bone scan assessed by Prostate Cancer Working Group 3 (PCWG3)). Per RECIST v1.1, CR=Disappearance of all target lesions; PR = \>=30% decrease in the sum of diameters of target lesions; For each treatment group, ORR is the number of patients with a CR and PR.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC	NCT04821622	Prostate Cancer	talazoparib plu... Placebo plus en...	18 Years -	Pfizer
ARON-3 Study: International Multicentric Retrospective Study to Collect Global Experiences in the Treatment of Patients With Metastatic PCa	NCT06200558	Prostate Cancer		18 Years -	Hospital of Macerata
ARON-3 Study: International Multicentric Retrospective Study to Collect Global Experiences in the Treatment of Patients With Metastatic PCa	NCT06200558	Prostate Cancer		18 Years -	Hospital of Macerata
A Study to Learn About Novel Hormonal Therapies in People With Metastatic Castration-Sensitive Prostate Cancer (mCSPC)	NCT06072196	Prostatic Neopl...	Novel hormonal ...	65 Years -	Pfizer
Study of Relugolix in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer	NCT04666129	Metastatic Cast... Metastatic Cast... Non-Metastatic ...	Relugolix Abiraterone Prednisone Methylprednisol... Apalutamide Docetaxel	18 Years -	Sumitomo Pharma Switzerland GmbH
The Study of Olaparib Combined With Abiraterone and Prednisone in mHSPC Patients With HRR Gene Mutation	NCT05167175	Prostate Cancer Prostate Carcin... Metastatic Pros...	Olaparib tablet Abiraterone ace... Prednisone tabl...	18 Years -	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study of Relugolix in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer	NCT04666129	Metastatic Cast... Metastatic Cast... Non-Metastatic ...	Relugolix Abiraterone Prednisone Methylprednisol... Apalutamide Docetaxel	18 Years -	Sumitomo Pharma Switzerland GmbH
Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC	NCT04821622	Prostate Cancer	talazoparib plu... Placebo plus en...	18 Years -	Pfizer
The Study of Olaparib Combined With Abiraterone and Prednisone in mHSPC Patients With HRR Gene Mutation	NCT05167175	Prostate Cancer Prostate Carcin... Metastatic Pros...	Olaparib tablet Abiraterone ace... Prednisone tabl...	18 Years -	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
A Study to Learn About Novel Hormonal Therapies in People With Metastatic Castration-Sensitive Prostate Cancer (mCSPC)	NCT06072196	Prostatic Neopl...	Novel hormonal ...	65 Years -	Pfizer

Spots Global Cancer Trial Database for mcspc

Every month we try and update this database with for mcspc 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 mcspc

Every month we try and update this database with for mcspc 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 mcspc 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.