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Apalutamide + ADT for Prostate Cancer (PROTEUS Trial)

Phase 3

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

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

Must have

Histologically confirmed adenocarcinoma of the prostate.

High risk disease (Gleason Score of 7 or greater).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 4 years

Awards & highlights

PROTEUS Trial Summary

This trial will compare the effectiveness of apalutamide + ADT vs placebo + ADT in men with high-risk prostate cancer before and after surgery. The main outcome measures are pCR rate and MFS.

Who is the study for?

Men with high-risk, localized or locally advanced prostate cancer who are candidates for surgery to remove the prostate and pelvic lymph nodes. They must be willing to undergo 13 months of treatment, have a Gleason Score of at least 7, no distant metastasis (M0 stage), and not have had prior treatments for prostate cancer or certain cardiovascular events in the past year.Check my eligibility

What is being tested?

The trial is testing if adding apalutamide to standard hormone therapy before and after surgical removal of the prostate improves outcomes like complete response rate and survival without metastasis compared to placebo plus hormone therapy.See study design

What are the potential side effects?

Apalutamide can cause fatigue, rash, joint pain, falls, fractures, hot flushes, diarrhea, nausea. Androgen deprivation therapy may lead to sexual dysfunction, hot flashes, reduced bone density/muscle mass and changes in mood.

PROTEUS Trial Eligibility Criteria

Inclusion Criteria

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

Select...

My prostate cancer is confirmed by tissue analysis.

Select...

My prostate cancer is considered high risk.

Select...

I can take care of myself and am up and about more than half of my waking hours.

Select...

Men who are participating in the study and their female partners who can become pregnant need to use approved birth control methods according to local regulations for people participating in clinical trials.

Select...

I am willing to undergo 13 months of treatment and can continue hormone therapy if not surgically castrated.

PROTEUS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 4 years 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 (MFS)

Percentage of Participants with Pathologic complete response (pCR)

Secondary outcome measures

Event Free Survival (EFS)

MFS Based on Conventional Imaging

Number of Participants with Adverse Events

+7 more

Side effects data

From 2021 Phase 2 trial • 86 Patients • NCT03279250

74%

Hot flashes

71%

Fatigue

44%

Anemia

38%

Hyperglycemia

26%

AST increase

26%

Hypertension

26%

Lipase increase

24%

ALT increase

24%

Dry skin

21%

Rash

18%

ACTH increase

18%

Cholesterol high

15%

Amylase increase

15%

Dizziness

12%

Memory impairment

12%

White blood cell decrease

12%

Constipation

12%

Lymphocyte count decrease

Myalgia

Paresthesia

Weight loss

Arthralgia

Hypothyrodism

LDH increase

Personality change

Erectile dysfunction

Headache

Dysgeusia

Dyspnea

HbA1c increased

Hypertriglyceridemia

Insomnia

Irritability

Anxiety

Atrial fibrillation

Bruising

Anorexia

Hypercalcemia

Dehydration

TSH increased

100%

80%

60%

40%

20%

Study treatment Arm

Arm B (LHRHa, Apalutamide, Abiraterone Acetate)

Arm A (LHRHa, Apalutamide)

PROTEUS Trial Design

2Treatment groups

Experimental Treatment

Group I: Placebo + ADTExperimental Treatment2 Interventions

Participants will receive ADT with oral administration of matching placebo treatment daily in each cycle (each cycle of 28 days). Participants will receive six cycles of placebo treatment, followed by RP with pLND, followed by an additional six cycles of placebo treatment.

Group II: Apalutamide + ADTExperimental Treatment2 Interventions

Participants will receive androgen deprivation therapy (ADT) plus oral administration of apalutamide 240 milligram (mg) (4 tablets of 60 mg each) daily in each cycle (each cycle of 28 days). Participants will receive six cycles of treatment, followed by radical prostatectomy (RP) with pelvic lymph node dissection (pLND), followed by an additional six cycles of treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Apalutamide

2015

Completed Phase 2

~3310

Androgen Deprivation Therapy (ADT)

2005

Completed Phase 3

~530

Placebo

1995

Completed Phase 3

~2670

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

975 Previous Clinical Trials

6,381,791 Total Patients Enrolled

8 Trials studying Prostate Cancer

2,178 Patients Enrolled for Prostate Cancer

Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC

745 Previous Clinical Trials

3,957,388 Total Patients Enrolled

7 Trials studying Prostate Cancer

2,688 Patients Enrolled for Prostate Cancer

Media Library

Androgen Deprivation Therapy (ADT) Clinical Trial Eligibility Overview. Trial Name: NCT03767244 — Phase 3

Prostate Cancer Research Study Groups: Apalutamide + ADT, Placebo + ADT

Prostate Cancer Clinical Trial 2023: Androgen Deprivation Therapy (ADT) Highlights & Side Effects. Trial Name: NCT03767244 — Phase 3

Androgen Deprivation Therapy (ADT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03767244 — Phase 3

Frequently Asked Questions

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

What benefits could this clinical trial offer patients?

"The primary outcome measure for this trial, which will be tracked over the course of approximately 4 years, is Metastasis-Free Survival (MFS). Additionally, secondary outcomes including Time to Distant Metastasis (TTDM), Event Free Survival (EFS), and Prostate Specific Antigen (PSA)-Free Survival will also be monitored."

Answered by AI

Could you please explain the Apalutamide's side effects?

"Apalutamide's safety is estimated to be a 3. This rating comes from the fact that Apalutamide is in Phase 3 of clinical trials."

Answered by AI

What is the precedent for Apalutamide research?

"At the current moment, there are 46 global clinical trials for Apalutamide with 16 of them being in Phase 3. Most of these studies are based out of Marshfield, Wisconsin; however, there are 2752 locations running trials for Apalutamide worldwide."

Answered by AI

Can anyone participate in this research project at present?

"That is correct. The information available on clinicaltrials.gov suggests that this trial is still in the process of recruiting patients. This study was first posted on June 11th, 2019 and has since been edited October 25th, 2022. So far, 46 sites have enrolled 2500 patients total."

Answered by AI

Is this clinical trial testing a new medication?

"There are currently 46 ongoing trials for Apalutamide in 580 cities across 40 countries. The first trial was conducted in 2013 and completed its final stage of drug approval in Phase 3. A total of 18296 trials have been conducted since the original study."

Answered by AI

What is the uppermost limit for patients who can enroll in this clinical trial?

"In order to move forward with this research, 2500 willing and eligible patients must enroll. If you are based in Greensboro, North carolina or Los Angeles, California, know that there are multiple locations where you can take part in this study."

Answered by AI

In how many different medical sites is this study being conducted today?

"Presently, this clinical trial is running in 46 locations which include Greensboro, Los Angeles and Houston. To limit travel as a requirement of participation, make sure to select the clinic that is nearest to your location."

Answered by AI

Recent research and studies

Journal of UrologyJournal

Neoadjuvant Novel Hormonal Therapy Followed by Prostatectomy Versus Up-front Prostatectomy for High-risk Prostate Cancer: A Comparative Analysis

Ravi, Praful, Lucia Kwak, Wanling Xie, Kaitlin Kelleher, Andres M. Acosta, Rana R. McKay, Adam S. Kibel, and Mary-Ellen Taplin. 2022. “Neoadjuvant Novel Hormonal Therapy Followed by Prostatectomy Versus Up-front Prostatectomy for High-risk Prostate Cancer: A Comparative Analysis”. Journal of Urology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/ju.0000000000002803.

clinicaltrials.govStudy

A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy

2019. "A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03767244.

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