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PROSTATE-IQ: Apalutamide for Prostate Cancer After Surgery and Radiation

This study, PROSTATE-IQ, is looking at ways to improve quality of life for men with prostate cancer after they've had surgery (prostatectomy) and are receiving radiation therapy. It aims to see if apalutamide, a drug given by mouth, can help reduce fatigue and other side effects compared to standard treatment. You might be able to join if you are a man over 18 with prostate cancer that has returned after surgery (detectable PSA) and are a candidate for radiation and hormone therapy (Androgen Deprivation Therapy or ADT). The main goal is to measure fatigue using a special questionnaire (FACIT-Fatigue) over about one year to see if apalutamide-based treatment makes a difference. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 120 men. It compares different treatment approaches for prostate cancer.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Fatigue will be measured through study completion, which is an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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.

Recruiting
PHASE3Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~120 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:ApalutamideAndrogen Deprivation Therapy

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue)
Measured over Through study completion; an average of 1 year.

Conditions

Androgen Axis Suppression
Prostatectomy
Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

6 sites across 6 states
Arizona1
Illinois1
Kansas1
Massachusetts1
New York1
Texas1

Study leadership

  • Karen Hoffman, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Karen Hoffman, MD
[email protected]
(713) 563-2339
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year prior to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign CNS or meningeal disease which may require treatment with surgery or radiation therapy).
Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomization. Any condition that in the opinion of the investigator, would preclude participation in this study. 5. Current evidence of any of the following:
Uncontrolled hypertension (consistently \>160 systolic or \>100 diastolic)
Gastrointestinal disorder affecting absorption
Active infection (eg, human immunodeficiency virus \[HIV\] or viral hepatitis).
Any condition that in the opinion of the investigator, would preclude participation in this study. 6. Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

What this trial measures

  • Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue)Through study completion; an average of 1 year.

    Score scale ranges (0-4) 0 - Not at all 1. \- A little bit 2. \- Somewhat 3. \- Quite a bit 4. \- Very Much