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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 up to 4 years
Awards & highlights
Pivotal Trial

Summary

This trial is testing if using apalutamide and hormone therapy around the time of surgery can help men with high-risk prostate cancer by reducing the hormones that help the cancer grow.

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.
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.
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.

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Metastasis-Free Survival (MFS)
Percentage of Participants with Pathologic complete response (pCR)
Secondary study objectives
Event Free Survival (EFS)
MFS Based on Conventional Imaging
Number of Participants with Laboratory Abnormalities as a Measure of Safety and Tolerability
+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%
Dizziness
15%
Amylase increase
12%
Memory impairment
12%
White blood cell decrease
12%
Constipation
12%
Lymphocyte count decrease
9%
Myalgia
9%
Paresthesia
9%
Weight loss
9%
Arthralgia
9%
Hypothyrodism
9%
LDH increase
6%
Erectile dysfunction
6%
Headache
6%
Personality change
6%
Dysgeusia
6%
Dyspnea
6%
HbA1c increased
6%
Hypertriglyceridemia
6%
Insomnia
6%
Irritability
3%
Anorexia
3%
Atrial fibrillation
3%
Anxiety
3%
Bruising
3%
Hypercalcemia
3%
Dehydration
3%
TSH increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (LHRHa, Apalutamide, Abiraterone Acetate)
Arm A (LHRHa, Apalutamide)

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
Androgen Deprivation Therapy (ADT)
2005
Completed Phase 3
~610
Placebo
1995
Completed Phase 3
~2670
Apalutamide
2015
Completed Phase 2
~5660

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Prostate cancer treatments often target the androgen receptor pathway, which is crucial for the growth and survival of prostate cancer cells. Androgen deprivation therapy (ADT) reduces androgen levels, thereby limiting cancer cell growth. Androgen receptor inhibitors like apalutamide and enzalutamide block the androgen receptor, preventing androgens from stimulating cancer cells. Abiraterone inhibits androgen production by blocking the enzyme CYP17. These treatments are vital as they effectively slow disease progression and improve survival rates in prostate cancer patients by disrupting the hormonal signals that drive cancer growth.

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
991 Previous Clinical Trials
6,384,334 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
757 Previous Clinical Trials
3,960,134 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
~478 spots leftby Feb 2026
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