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Randomized Phase II Study of Salvage XRT + ADT +/- Abiraterone and Apalutamide for Rising PSA After RP (FORMULA-509)

NCT03141671 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 345

Last updated 2024-05-14

No results posted yet for this study

Summary

This research study is comparing two different combinations of androgen deprivation therapy (ADT) used together with radiation as a treatment for rising PSA after radical prostatectomy (prostate cancer).

Conditions

Interventions

DRUG

GnRH

-blocks the function of hormones including testosterone which prostate cancer uses to grow and spread

DRUG

Bicalutamide

-blocks the function of hormones including testosterone which prostate cancer uses to grow and spread

RADIATION

Salvage radiation

Radiation

DRUG

Abiraterone

-blocks the function of hormones including testosterone which prostate cancer uses to grow and spread

DRUG

Prednisone

Prednisone is a corticosteroid. It prevents the release of substances in the body that cause inflammation. It also suppresses the immune system.

DRUG

Apalutamide

-blocks the function of hormones including testosterone which prostate cancer uses to grow and spread

Sponsors & Collaborators

Principal Investigators

  • Paul Nguyen, MD · Dana-Farber/Brigham and Women's Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-24
Primary Completion
2025-04-05
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03141671 on ClinicalTrials.gov