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Led by M.D. Anderson Cancer Center · Updated on 2026-07-22
120
Participants Needed
6
Research Sites
104 weeks
Total Duration
Researchers are investigating personalized treatments for prostate cancer patients who have detectable PSA after prostatectomy. This study is comparing fatigue and quality of life outcomes between different durations and combinations of apalutamide and androgen deprivation therapy ADT along with radiation therapy. The goal is to understand if apalutamide-based treatments can reduce fatigue and side effects compared to standard therapy, focusing on both less aggressive and more aggressive disease groups. Participants are randomly assigned to one of four groups six months of ADT with radiation, six months of apalutamide with radiation, 24 months of ADT with radiation, or six months of combined ADT and apalutamide with radiation. The study involves different treatment durations depending on disease aggressiveness. Apalutamide and ADT are given orally, and radiation therapy is part of all treatment arms. The study is designed as a phase III, multi-center trial evaluating personalized androgen axis suppression. During the study, participants will complete questionnaires assessing fatigue, quality of life, cognitive function, and mental health. Physical activity, sleep, body composition, blood tests, and physician-reported toxicities will be monitored. Researchers will also evaluate time to testosterone recovery, progression-free survival, and cardiovascular risks. Optional genetic and biomarker studies are included. The study may last several years with assessments up to 24 months for some outcomes, ensuring comprehensive monitoring of treatment impact and safety.
CONDITIONS
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.
K
Karen Hoffman, MD
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M.D. Anderson Cancer Center
Lead Sponsor
Janssen Scientific Affairs, LLC
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Apalutamide + ADT (lower‑risk cohort) | ADT (lower‑risk cohort) | Apalutamide + ADT (higher‑risk cohort) | ADT (higher‑risk cohort) | Standard salvage radiation + ADT |
|---|---|---|---|---|---|
| What it is | Apalutamide added to ADT plus postoperative radiation in lower‑risk cohort | Standard ADT plus postoperative radiation in lower‑risk cohort | Apalutamide added to ADT plus postoperative radiation in higher‑risk cohort | Standard ADT plus postoperative radiation in higher‑risk cohort | Salvage radiation therapy combined with ADT is the current standard of care for men with detectable PSA after prostatectomy |
| Role in trial | Experimental treatment arm | Control arm receiving standard ADT + radiation | Experimental treatment arm | Control arm receiving standard ADT + radiation | Current guideline‑based treatment outside the trial |
| Primary purpose | To test whether adding apalutamide reduces fatigue and improves quality of life while treating PSA recurrence (lower‑risk cohort) | To serve as comparator for fatigue and quality‑of‑life outcomes (lower‑risk cohort) | To test whether adding apalutamide impacts fatigue and quality of life over longer duration in higher‑risk cohort | To serve as comparator for fatigue and quality‑of‑life outcomes (higher‑risk cohort) | Represents typical salvage therapy aimed at controlling PSA recurrence |
| How it is given | Apalutamide plus ADT given orally alongside postoperative radiation | ADT given orally with postoperative radiation | Apalutamide plus ADT given orally alongside postoperative radiation | ADT given orally with postoperative radiation | ADT plus salvage radiation delivered per standard clinical practice |
| Evidence status | Effect on fatigue and quality of life is being evaluated; no outcomes reported yet | Standard regimen has known PSA control benefit but may impair quality of life | Effect on fatigue and quality of life over extended period being assessed; outcomes unknown | Standard regimen expected to control PSA recurrence in high‑risk patients, per guidelines | Salvage RT plus ADT is recommended to delay progression in PSA recurrence |
| Important risks | Risks associated with apalutamide plus ADT plus radiation are not yet established | ADT plus radiation can cause common side effects like fatigue, urinary, bowel, and sexual function impacts | Risks of prolonged apalutamide plus ADT plus radiation are under study | Standard ADT plus radiation known to carry risks to urinary, bowel, and sexual health | Salvage RT plus ADT carries recognized side effect risks to urinary control, bowel, and sexual health |
| Important limitations | No published data yet on fatigue, QoL, or oncologic outcomes | Potential quality‑of‑life impacts from ADT and radiation may affect fatigue outcomes | Outcomes for higher‑risk cohort not yet available, including long‑term toxicity and benefit | Extended duration of ADT may increase side effects and delay recovery | ADT plus salvage radiation delays progression but may cause fatigue and reduce quality of life |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 to 24 months depending on treatment group
Participants receive one of four treatments: six months of androgen deprivation therapy with radiation, six months of apalutamide with radiation, 24 months of androgen deprivation therapy with radiation, or six months of combined androgen deprivation therapy and apalutamide with radiation.
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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Constantinos Zamboglou, William De Doncker, Andreas Thomas Christoforou...
https://pubmed.ncbi.nlm.nih.gov/40645505/M.D. Anderson Cancer Center
Lead Sponsor
Janssen Scientific Affairs, LLC
Collaborating Sponsor
