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

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Atezolizumab

Hormones

Abiraterone Acetate

Prednisone

Glucocorticoids

Hormone Antagonists

Antineoplastic Agents, Hormonal

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Participants will have untreated metastatic (M1a/b/c) hormone-sensitive prostate cancer documented by positive bone scan or metastatic lesion on CT or MRI; untreated is defined as having never received surgical, radiotherapeutic, or systemic therapy for their prostate cancer.Group 1 and 2. The first 20 patients enrolled will be in Group 1 and the remaining patients (and those who are already on a GnRH analog) will be assigned to Group 2. All study participants will receive treatment with atezolizumab, abiraterone acetate, prednisone, GnRH analog, and SBRT, at the same doses.

Atezolizumab 1200 mg IV over 60 minutes every 3 weeks

Abiraterone

Any GnRH analog that is commercially available, injectable, and long acting analog of the native LHRH peptide and is administered to subjects via intramuscular injection. For this study, any GnRH analog can be used and thee manufacturer's instructions for dose and frequency should be followed.

GnRH analog

Intensity-modulated, image-guided, ultra-hypofractionated external beam radiotherapy (7.25-7.5 Gy x 5 to prostate and seminal vesicles QOD) will begin around 12 weeks (at Cycle 5 Day 1 (+/-5 days)

Stereotactic Body Radiotherapy (SBRT)

Enzalutamide

Subjects who discontinue study treatment for reasons other than progression will be followed every 6 months (+/- 4 weeks) until a documented progression event (i.e., PSA, radiographic, or clinical progression). After a documented progressionevent (whether on treatment or during follow up), subjects will continue to be followed every 6 months (+/- 4 weeks) for overall survival via chart review and/or telephone call.

Follow up

Dana Rathkopf, MD

This study is to find out whether adding the study drug atezolizumab and stereotactic body radiotherapy (SBRT) to standard treatment with abiraterone acetate, prednisone, and Lupron® (leuprolide) is a safe and effective way to treat previously untreated metastatic prostate cancer, and to see whether the study treatment works better than the standard treatment.

Study of Abiraterone Acetate or Enzalutamide, Atezolizumab, GnRH Analog and Radiation Therapy in Men With Newly Diagnosed Hormone-sensitive Prostate Cancer

SAABR: Single Arm Phase II Study of AR Targeted Therapy + Atezolizumab + GnRH Analog and Stereotactic Body Radiotherapy (SBRT) to the Prostate in Men With Newly Diagnosed Hormone-sensitive Metastatic Prostate Cancer

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Failure is defined as: biochemical failure, radiographic progression defined by PCWG3, or death from any cause.

Genentech, Inc.

Stand Up To Cancer

Memorial Sloan Kettering Cancer Center

Symptoms and General Pathology

Behaviors and Mental Disorders

Recurrence

Aggression

Reproductive Control Agents

Androgens

Leuprolide

Goserelin

Triptorelin Pamoate

Bicalutamide

Androgen Antagonists

Salvage RT will be given 66.0 - 70.2 Gy along with 24 months of a GnRH analog with or without 1-4 months of bicalutamide.

Salvage RT will be given 66.0 - 70.2 Gy along with 24 months of a GnRH analog + 24 months of enzalutamide.

Radiation Therapy

Edwin Posadas, MD

Hiram Gay, MD

Patients with post-prostatectomy PSA (Prostate Specific Antigen) recurrences with aggressive disease features will receive salvage radiation therapy and standard androgen deprivation therapy (ADT) or enhanced ADT to determine if there is any improvement in progression-free survival when enhanced ADT is used compared to standard ADT.

PRIMARY OBJECTIVE:

To determine whether, in men with post-prostatectomy PSA (prostate specific antigen) recurrences with aggressive disease features, salvage radiotherapy (SRT) with enhanced androgen deprivation therapy (ADT), consisting of enzalutamide (MDV3100) and a GnRH analog, will improve progression-free survival compared to SRT with standard GnRH analog -based ADT.

A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following Surgery

STEEL: A Randomized Phase II Trial of Salvage Radiotherapy With Standard vs Enhanced Androgen Deprivation Therapy (With Enzalutamide) in Patients With Post-Prostatectomy PSA Recurrences With Aggressive Disease Features

The time from the date of randomization to the date of progression, death from any cause or last known follow-up date.

Pfizer

Astellas Pharma Inc

RTOG Foundation, Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Abiraterone Acetate or Enzalutamide, Atezolizumab, GnRH Analog and Radiation Therapy in Men With Newly Diagnosed Hormone-sensitive Prostate Cancer	NCT04262154	Metastatic Pros...	Atezolizumab Abiraterone Prednisone GnRH analog Stereotactic Bo... Enzalutamide Follow up	18 Years -	Memorial Sloan Kettering Cancer Center
A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following Surgery	NCT03809000	Prostate Cancer	Radiation Thera... Enzalutamide Bicalutamide GnRH analog	18 Years -	RTOG Foundation, Inc.
Study of Abiraterone Acetate or Enzalutamide, Atezolizumab, GnRH Analog and Radiation Therapy in Men With Newly Diagnosed Hormone-sensitive Prostate Cancer	NCT04262154	Metastatic Pros...	Atezolizumab Abiraterone Prednisone GnRH analog Stereotactic Bo... Enzalutamide Follow up	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for gnrh analog

Every month we try and update this database with for gnrh analog 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 gnrh analog

Every month we try and update this database with for gnrh analog 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 gnrh analog 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.