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Androgen Receptor Inhibitor

Apalutamide + Hormone Therapy for Prostate Cancer

Q: What is the conventional purpose of GnRH (agonist)?

GnRH (agonist) can be used to effectively treat <a href="https://www.withpower.com/clinical-trials/prostate-cancer">prostate cancer</a> non-metastatic, stage d2 prostatic carcinoma, and ovulation induction therapy.

Q: Is this a new procedure that has never been tried before?

There are a total of 118 ongoing clinical trials for GnRH (agonist) across the globe, in 1037 cities and 47 countries. The first trial was conducted in 2000 and completed its Phase 3 drug approval stage that same year. Since then, there have been a total of 179 clinical trials conducted.

Q: Has the FDA cleared GnRH (agonist) for use?

There is some evidence, from both this Phase 3 trial and other research supporting the safety of GnRH (agonist), so it received a score of 3.

Q: Are participants being recruited for this experiment at the current time?

The study detailed on clinicaltrials.gov is not enrolling patients at the moment, though this could change in the future. This particular trial was first posted on November 19th, 2015 and received its most recent update on October 25th, 2022. There are currently 1,402 other trials looking for participants.

Q: What have been the findings of other scientific investigations into GnRH (agonist)?

There are 118 ongoing trials studying GnRH (agonist), with 37 of those in Phase 3. Many of the studies for this treatment originate from Chicago, <a href="https://www.withpower.com/clinical-trials/illinois">Illinois</a>; however, there are 6706 locations running these sorts of trials.

Q: In how many hospitals is this study being conducted?

Currently, this trial is being conducted at 74 different sites. If you are considering participation, know that there may be a location near you as the centres are situated in San Antonio, Scarborough, Fort Myers and 71 other locations.

Q: How many trial participants are enrolled in this experiment?

Unfortunately, this particular clinical trial is no longer looking for patients. The study was created on 11/19/2015 and had its last update on 10/25/2022. However, there are other ongoing studies that might be of interest. For example, right now there are 1284 trials involving <a href="https://www.withpower.com/clinical-trials/prostate-cancer">prostate cancer</a> and 118 GnRH (agonist) studies currently enrolling patients.

Phase 3

Waitlist Available

Research Sponsored by Aragon Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) grade of 0 or 1

Age >= 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 108 months

Awards & highlights

Study Summary

This trial will test whether adding apalutamide to standard hormone therapy can help men with high-risk prostate cancer that has not spread live longer without the disease progressing.

Who is the study for?

Men over 18 with high-risk, localized or locally advanced prostate cancer who are set to receive primary radiation therapy. They must be in good health with a low Charlson index (<=3), able to swallow pills, and have normal liver function and adequate blood counts. Participants should not have had prior treatments for prostate cancer, no history of seizures or conditions that may cause them, and agree to use condoms.Check my eligibility

What is being tested?

The trial is testing if adding apalutamide plus GnRH agonist to the standard radiation treatment improves survival without metastasis in men with high-risk prostate cancer. It compares this combination against placebo versions while all participants receive radiation therapy.See study design

What are the potential side effects?

Apalutamide can cause fatigue, rash, joint pain, falls, fractures, hot flushes, diarrhea, nausea; it might also affect thyroid function. GnRH agonists typically lead to symptoms like hot flashes and reduced sexual interest due to lower testosterone levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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I am 18 years old or older.

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I can swallow pills without any difficulty.

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My prostate cancer is aggressive based on its Gleason score and PSA levels.

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I am scheduled for initial radiation therapy for prostate cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 108 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~108 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 108 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Metastasis-free survival

Secondary outcome measures

Event-free Survival

MFS by Conventional or Positron Emission Tomography (PET) Imaging

Overall Survival (OS)

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ApalutamideExperimental Treatment4 Interventions

Participants will receive apalutamide (240 mg), by mouth, once daily for overall 30 months, plus bicalutamide placebo, by mouth, once daily, for four months from randomization. All participants are treated with gonadotropin releasing hormone (GnRH) agonist for 30 months from randomization and radiation therapy to the prostate started at about 8 weeks after randomization.

Group II: Control groupActive Control4 Interventions

Participants will receive apalutamide placebo, by mouth, once daily for overall 30 months, plus bicalutamide (50 mg), by mouth, once daily, for four months from randomization. All participants are treated with gonadotropin releasing hormone (GnRH) agonist for 30 months from randomization and radiation therapy to the prostate started at about 8 weeks after randomization.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Apalutamide

2015

Completed Phase 2

~3310

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Aragon Pharmaceuticals, Inc.Lead Sponsor

16 Previous Clinical Trials

3,871 Total Patients Enrolled

5 Trials studying Prostate Cancer

1,284 Patients Enrolled for Prostate Cancer

Aragon Pharmaceuticals, Inc. Clinical TrialStudy DirectorAragon Pharmaceuticals, Inc.

3 Previous Clinical Trials

1,264 Total Patients Enrolled

Media Library

Apalutamide (Androgen Receptor Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02531516 — Phase 3

Prostate Cancer Research Study Groups: Apalutamide, Control group

Prostate Cancer Clinical Trial 2023: Apalutamide Highlights & Side Effects. Trial Name: NCT02531516 — Phase 3

Apalutamide (Androgen Receptor Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02531516 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the conventional purpose of GnRH (agonist)?

"GnRH (agonist) can be used to effectively treat prostate cancer non-metastatic, stage d2 prostatic carcinoma, and ovulation induction therapy."

Answered by AI

Is this a new procedure that has never been tried before?

"There are a total of 118 ongoing clinical trials for GnRH (agonist) across the globe, in 1037 cities and 47 countries. The first trial was conducted in 2000 and completed its Phase 3 drug approval stage that same year. Since then, there have been a total of 179 clinical trials conducted."

Answered by AI

Has the FDA cleared GnRH (agonist) for use?

"There is some evidence, from both this Phase 3 trial and other research supporting the safety of GnRH (agonist), so it received a score of 3."

Answered by AI

Are participants being recruited for this experiment at the current time?

"The study detailed on clinicaltrials.gov is not enrolling patients at the moment, though this could change in the future. This particular trial was first posted on November 19th, 2015 and received its most recent update on October 25th, 2022. There are currently 1,402 other trials looking for participants."

Answered by AI

What have been the findings of other scientific investigations into GnRH (agonist)?

"There are 118 ongoing trials studying GnRH (agonist), with 37 of those in Phase 3. Many of the studies for this treatment originate from Chicago, Illinois; however, there are 6706 locations running these sorts of trials."

Answered by AI

In how many hospitals is this study being conducted?

"Currently, this trial is being conducted at 74 different sites. If you are considering participation, know that there may be a location near you as the centres are situated in San Antonio, Scarborough, Fort Myers and 71 other locations."

Answered by AI

How many trial participants are enrolled in this experiment?

"Unfortunately, this particular clinical trial is no longer looking for patients. The study was created on 11/19/2015 and had its last update on 10/25/2022. However, there are other ongoing studies that might be of interest. For example, right now there are 1284 trials involving prostate cancer and 118 GnRH (agonist) studies currently enrolling patients."

Answered by AI