RecruitingPhase 3NCT06274047

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.


Sponsor

M.D. Anderson Cancer Center

Enrollment

120 participants

Start Date

Sep 10, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

1. Personalize treatment for prostate cancer based on how aggressive the disease is and 2. Learn if apalutamide-based treatment can help to reduce fatigue and other side effects of treatment in participants who are being treated with radiation therapy for prostate cancer, as compared to standard therapy.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether apalutamide — a hormone-blocking drug used for prostate cancer — can improve cancer control and quality of life when added to salvage radiation therapy and standard hormone therapy in men whose PSA has risen after having their prostate surgically removed. **You may be eligible if...** - You have been diagnosed with prostate cancer confirmed by biopsy - Your PSA level has risen to 0.1 or above after prostate removal surgery - Your doctor has recommended salvage radiation and hormone therapy - You are 18 or older - Your general health is good (ECOG performance status 0–2) **You may NOT be eligible if...** - Your organ function or blood counts are below required thresholds - You have serious liver, kidney, or heart conditions that would make treatment unsafe - You are on medications that interact with apalutamide Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGApalutamide

Given by PO

DRUGAndrogen Deprivation Therapy

Given by PO


Locations(3)

University of Kansas Medical Center

Kansas City, Kansas, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

MD Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06274047


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