Personalized Apalutamide Treatment for Prostate Cancer

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 Phase 3 Interventional Study
Androgen Axis Suppression Prostatectomy Prostate Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Male
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
120 (estimated)
Sponsor
M.D. Anderson Cancer Center · Other
Who this trial is looking for

This trial is looking for men who have prostate cancer and have detectable PSA levels after surgery. Participants will receive treatment with apalutamide to see if it helps reduce fatigue and side effects during radiation therapy.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with prostate cancer.
  • My PSA level is 0.1 or higher after surgery.
  • I am a candidate for radiation treatment and androgen deprivation therapy.
  • I am over 18 years old.
  • I can comply with study procedures.
  • I understand English or Spanish.
  • I can provide written informed consent.

You may not be able to join if

  • I have used testosterone suppression treatment before this study.
  • I have active bone disease or extrapelvic disease.
  • I have had a seizure or a condition that may cause seizures.
  • I have had severe heart problems in the past 6 months.
  • I have uncontrolled high blood pressure.
  • I have an active infection like HIV or viral hepatitis.
  • I am taking medications that lower the seizure threshold.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

Check Your Eligibility
About This Trial

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.

Trial Locations
Loading…

Loading trial locations…

Eligibility Criteria
Inclusion Criteria: 1. Histologically confirmed prostate cancer. 2. PSA ≥ 0.1 after radical prostatectomy. 3. Candidate for salvage radiation and ADT treatment, as determined by treating physician. 4. Age \>18 at the time of consent. 5. ECOG Performance Status ≤ 2. 6. Demonstrate adequate organ fun…
Contacts

Karen Hoffman, MD

(713) 563-2339

khoffman1@mdanderson.org

CONTACT