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Antiandrogen

Arm 1 for Prostatectomy

Phase 3

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year.

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year.

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

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

Primary outcome measures

Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue)

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

~3310

Androgen Deprivation Therapy

2008

Completed Phase 2

~110

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Scientific Affairs, LLCIndustry Sponsor

159 Previous Clinical Trials

580,398 Total Patients Enrolled

M.D. Anderson Cancer CenterLead Sponsor

2,966 Previous Clinical Trials

1,804,661 Total Patients Enrolled

Karen Hoffman, MDPrincipal InvestigatorM.D. Anderson Cancer Center

1 Previous Clinical Trials

985 Total Patients Enrolled

Frequently Asked Questions

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

What level of risk does treatment Arm 1 pose to patients?

"Our research team at Power has assessed the safety of Arm 1 to be at a level 3 on our scale. This rating is influenced by the trial being in its Phase 3 stage, indicating existing evidence supporting both effectiveness and repeated affirmations of safety."

Answered by AI

Is the enrollment process still open for individuals interested in participating in this trial?

"The research listed on clinicaltrials.gov is not currently open for participant recruitment. Originally uploaded on August 31, 2024, the most recent revision took place on February 16, 2024. Despite this trial being inactive in terms of patient enrollment, there are a total of 1400 ongoing trials actively seeking participants presently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PROSTATE-IQ: Parallel RandOmized STudy of Personalized Apalutamide Treatment and Evaluation to Improve Quality of Life in Post-Operative Radiation With Androgen Axis Suppression. A Phase III Multi-center Study for Men With Detectable PSA After Prostatectomy for Prostate Cancer.

2024. "PROSTATE-IQ: Parallel RandOmized STudy of Personalized Apalutamide Treatment and Evaluation to Improve Quality of Life in Post-Operative Radiation With Androgen Axis Suppression. A Phase III Multi-center Study for Men With Detectable PSA After Prostatectomy for Prostate Cancer.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06274047.