(UroToday.com) The 2024 American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago, IL between May 31st and June 4th, 2024 was host to a prostate, testicular, and penile cancers trials in progress poster session. Dr. Karen Hoffman presented the PROSTATE-IQ randomized trial to reduce androgen deprivation therapy (ADT) treatment burden for patients with biochemical recurrence after a radical prostatectomy.
Men with a PSA recurrence following radical prostatectomy often receive ADT plus salvage radiation therapy to the prostate resection bed. Traditional ADT improves cancer control; however, it also causes fatigue, sexual dysfunction, hot flashes, cognitive changes, metabolic dysregulation, body composition changes and negatively impacts men’s quality of life. Two randomized trials have demonstrated the benefit from increasing the ADT given with salvage radiation therapy:
- In the RADICALS-HD trial, lengthening ADT duration to 24 months improved metastasis-free survival (MFS) compared to 6 months of ADT1
- In the FORMULA 509 trial, 6 months of an intensified ADT regimen (Apalutamide, Abiraterone, Prednisone, and GnRH agonist) improved MFS compared to 6 months of traditional ADT (GnRH agonist and bicalutamide)2
The PROSTATE-IQ trial (NCT06274047) is a randomized multi-center clinical trial that is:
- Using the ArteraAI Post-RP Test and cancer characteristics to tailor the intensity of androgen axis treatment by identifying “Artera Low” and “Higher Risk” patients.
- Investigating apalutamide-based therapies as an alternative to traditional ADT
- The investigators hypothesize that apalutamide-based therapies will reduce the adverse effects of androgen axis treatment.
The “Artera Low” cohort will be randomized between 6 months of apalutamide monotherapy and 6 months of traditional ADT. The “Higher Risk” cohort is randomized between 6 months of ADT plus apalutamide (“winning approach” of FORMULA-509) and 24 months of ADT (“winning arm” of RADICALS-HD).
The primary study outcome is patient-reported fatigue, as measured by FACIT-fatigue, a 13-item validated questionnaire. Scores range from 0 to 52. A change of three is considered statistically significant. Secondary outcomes evaluating the impact of treatment include:
- Patient-reported quality of life (FACT-P, EPIC-26)
- Activity and sleep assessment (activity tracking wearables and questionnaires)
- Cognitive assessment
- Body composition changes
- Testosterone kinetics
- Cardiovascular events.
Secondary outcomes evaluating cancer control include progression-free survival and metastasis-free survival.
Statistical considerations are as follows:
- 100 analyzable patients in each group will have 80% power to detect an effect size of 0.4 standard deviations at a two-sided significance level.
- This will permit the detection of a clinically meaningful difference in fatigue.
- The investigators assumed a ten percent attrition rate. They will randomize 440 patients, 220 patients to each group (Artera Low and Higher Risk).
Presented by: Karen E. Hoffman, MD, MHSc, MPH, Professor, Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX
Written by: Rashid Sayyid, MD, MSc – Society of Urologic Oncology (SUO) Clinical Fellow at The University of Toronto, @rksayyid on Twitter during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, Chicago, IL, May 31st – June 4th, 2024
Related content: PROSTATE-IQ Trial: Reducing ADT Burden in Salvage Radiotherapy - Karen Hoffman
- Parker CC, Kynaston H, Cook AD, et al. Duration of androgen deprivation therapy with postoperative radiotherapy for prostate cancer: a comparison of long-course versus short-course androgen deprivation therapy in the RADICALS-HD randomised trial. Lancet. 2024: S0140-6736(24)00549-X.
- Nguyen PL, Kollmeier M, Rathkopf DE, et al. FORMULA-509: A multicenter randomized trial of post-operative salvage radiotherapy (SRT) and 6 months of GnRH agonist with or without abiraterone acetate/prednisone (AAP) and apalutamide (Apa) post-radical prostatectomy (RP). J Clin Oncol. 2023;41:6_suppl.