Actively Recruiting

Phase 3
Age: 18Years +
MALE
NCT06274047

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.

Led by M.D. Anderson Cancer Center · Updated on 2026-04-24

120

Participants Needed

3

Research Sites

250 weeks

Total Duration

On this page

Sponsors

M

M.D. Anderson Cancer Center

Lead Sponsor

J

Janssen Scientific Affairs, LLC

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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.

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed prostate cancer.
  • PSA  0.1 after radical prostatectomy.
  • Candidate for salvage radiation and ADT treatment as determined by treating physician.
  • Age greater than 18 years at time of consent.
  • ECOG Performance Status of 2 or less.
  • Adequate organ function with platelet count  100,000/bcl, hemoglobin  9 g/dL, eGFR  30 mL/min, bilirubin  1.5 x ULN, AST and ALT  2.5 x ULN, serum albumin  3.0 g/dL, and potassium  3.5 mmol/L.
  • Ability to understand and comply with study procedures.
  • Ability to understand English or Spanish.
  • Written informed consent and HIPAA authorization prior to registration.
Not Eligible

You will not qualify if you...

  • Use of post-prostatectomy testosterone suppression prior to registration (except with testosterone recovery >190 ng/dL).
  • History of seizure or conditions predisposing to seizure, recent stroke, brain or meningeal diseases requiring treatment.
  • Severe or unstable angina, recent myocardial infarction, symptomatic heart failure, thromboembolic events, or significant arrhythmias within 6 months.
  • Current uncontrolled hypertension (systolic >160 or diastolic >100).
  • Gastrointestinal disorders affecting absorption.
  • Active infection including HIV or viral hepatitis.
  • Any condition that would preclude study participation per investigator judgment.
  • Confirmed extrapelvic or bone disease.
  • Use of medications lowering seizure threshold must be stopped or changed 4 weeks before treatment if receiving apalutamide.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

University of Kansas Medical Center

Kansas City, Kansas, United States, 66103

Actively Recruiting

2

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Actively Recruiting

3

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

K

Karen Hoffman, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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