This phase II trial tests whether a shorter course of hormone therapy (androgen deprivation therapy [ADT]) in combination with radiation (hypofractionated pelvic radiation and brachytherapy) works in treating high-risk prostate cancer. High-risk prostate cancer means that the tumor has not spread outside the prostate region, the Gleason score is 8-10, and/or the prostate-specific antigen (PSA) level is over 20. Androgens (male hormones), including testosterone, can cause the growth of prostate cancer cells. Bicalutamide blocks the use of androgens by the tumor cells. Leuprolide lowers the amount of testosterone made by the body. This may help stop the growth of tumor cells that need testosterone to grow. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving a shorter course of ADT in combination with hypofractionated pelvic radiation and brachytherapy may be a safe and effective way to prevent high-risk prostate cancer from coming back and/or spreading to other parts of the body.
Additional locations may be listed on ClinicalTrials.gov for NCT05100472.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. 3-year metastasis-free rate will be used to evaluate efficacy of 6 months of ADT, hypofractionated pelvic external beam radiation therapy (EBRT), and a high-dose-rate (HDR) prostate brachytherapy boost in National Comprehensive Cancer Network (NCCN) high-risk prostate cancer patients with Decipher scores =< 0.6.
SECONDARY OBJECTIVES:
I. Evaluate 2-year post-treatment positive biopsy rate.
II. Evaluate 3-year cumulative incidence of biochemical failure.
III. Evaluate 3-year rate of salvage therapy.
IV. Evaluate 3-year cumulative incidence of prostate cancer specific death.
V. Evaluate 3-year overall survival rate.
VI. Evaluate acute and late physician-scored toxicity using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.
VII. Evaluate patient-reported quality of life outcomes using International Prostate Symptom Score (IPSS), International Index of Erectile Function-6 (IIEF-6), Expanded Prostate Cancer Index Composite-26 (EPIC-26), and Comprehensive Score for Financial Toxicity (COST) questionnaires.
OUTLINE:
Patients receive ADT consisting of bicalutamide orally (PO) once daily (QD), and beginning 1-2 weeks later, leuprolide subcutaneously (SC) every 3 months. ADT continues for 6 months in the absence of disease progression or unacceptable toxicity. Three months after the start of ADT, patients undergo a standard HDR prostate brachytherapy procedure, followed 4 weeks later by EBRT QD for 5 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 3, 6, 12, 24, and 36 months.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorDaniel Gorovets
