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Antiandrogen

Apalutamide + Hormone Therapy for Prostate Cancer

Phase 3
Recruiting
Led By Karen Hoffman, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >18 at the time of consent
Histologically confirmed prostate cancer
Must not have
Use of post-prostatectomy testosterone suppression prior to registration
History of seizure or conditions predisposing to seizure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year.
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial aims to customize treatment for prostate cancer based on the aggressiveness of the disease. It will investigate whether using apalutamide-based treatment can reduce fatigue and other side effects in patients undergoing radiation

Who is the study for?
This trial is for men with detectable PSA levels after prostatectomy, indicating prostate cancer may still be present. Participants should be undergoing radiation therapy and hormone treatment for their condition.
What is being tested?
The study aims to personalize prostate cancer treatment by testing if apalutamide can reduce fatigue compared to standard therapy in patients receiving post-operative radiation and hormone therapy.
What are the potential side effects?
Apalutamide may cause side effects such as tiredness, high blood pressure, skin rash, falls or fractures, diarrhea, weight loss, joint pain and hot flushes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 18 years old.
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My prostate cancer diagnosis was confirmed through a tissue examination.
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My blood tests show my organs are functioning well.
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I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have used testosterone suppression therapy after prostate surgery.
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I have a history of seizures or conditions that could lead to seizures.
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I do not have high blood pressure, absorption issues, or active infections.
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My cancer has spread beyond the pelvic area or to the bones.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Arm 4Experimental Treatment2 Interventions
Participants will receive 6 months of ADT, apalutamide, and radiation therapy.
Group II: Arm 3Experimental Treatment1 Intervention
Participants will receive 24 months of standard-of-care androgen deprivation therapy (ADT) and radiation therapy.
Group III: Arm 2Experimental Treatment1 Intervention
Participants will receive 6 months of apalutamide and radiation therapy.
Group IV: Arm 1Experimental Treatment1 Intervention
Participants will receive 6 months of standard-of-care androgen deprivation therapy (ADT) and radiation therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apalutamide
2015
Completed Phase 2
~5710
Androgen Deprivation Therapy
2008
Completed Phase 2
~110

Find a Location

Who is running the clinical trial?

Janssen Scientific Affairs, LLCIndustry Sponsor
164 Previous Clinical Trials
579,853 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
3,065 Previous Clinical Trials
1,802,104 Total Patients Enrolled
Karen Hoffman, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
985 Total Patients Enrolled
~80 spots leftby Jun 2027
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