Study Summary
This triallooks at if adding a drug to radiation and hormone therapy can delay the spread of cancer in the body.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 7 Secondary · Reporting Duration: Up to 7 years
Trial Safety
Safety Progress
Trial Design
4 Treatment Groups
Observational Cohort(Group3) PSMA-PET Negative Particitpans
1 of 4
Interventional Cohort (Group 1): RT+ LHRHa
1 of 4
Observational Cohort(Group3) PSMA-PET Negative Participants
1 of 4
Interventional Cohort (Group 2): RT+LHRHa + Apalutamide
1 of 4
Active Control
Experimental Treatment
412 Total Participants · 4 Treatment Groups
Primary Treatment: Interventional Cohort (Group 2): RT+LHRHa + Apalutamide · No Placebo Group · Phase 3
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · Male Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
What makes this clinical trial unique?
"There are 46 active clinical trials for Interventional Cohort (Group 2): RT+LHRHa + Apalutamide across 580 cities and 40 countries. Data suggests that the first trial was completed in 2013 by Aragon Pharmaceuticals, Inc. 1207 participants were involved and the study reached Phase 3 drug approval stage. In the 7 years since, 160 similar trials have been conducted." - Anonymous Online Contributor
Are there other similar studies to Interventional Cohort (Group 2): RT+LHRHa + Apalutamide?
"Currently, there are 46 clinical trials underway for Interventional Cohort (Group 2): RT+LHRHa + Apalutamide. Of these, 16 are in Phase 3. Although many of the studies for Interventional Cohort (Group 2): RT+LHRHa + Apalutamide are based in Marshfield, Wisconsin, there are a total of 2752 locations across the world where these trials are taking place." - Anonymous Online Contributor
Are new patients being recruited for this study?
"That is correct. The clinicaltrials.gov website indicates that this research project, which was first advertised on November 12th 2020, is looking for 412 individuals at a single site." - Anonymous Online Contributor
Has the FDA approved a course of treatment that includes Interventional Cohort (Group 2): RT+LHRHa + Apalutamide?
"There is some evidence to support the efficacy of Interventional Cohort (Group 2): RT+LHRHa + Apalutamide, as this is a Phase 3 trial. Furthermore, there are multiple rounds of data that suggest it is safe, so it received a score of 3." - Anonymous Online Contributor
How many people are part of this clinical trial at most?
"That is correct. As of 10/25/2022, the clinical trial indicated on clinicaltrials.gov was still recruiting patients. The posting dates for this study are 11/12/2020-10/25/2022 and it is seeking a total of 412 participants from 1 site location." - Anonymous Online Contributor