About this trial
This study looks at how combined radiation and hormone therapy affects sexual function in men with a specific type of prostate cancer, before and after treatment.
Eligibility criteria
Qualifiers
Men aged 18-80 years with biopsy-proven UIR-PCa (National Comprehensive Cancer Network [NCCN] criteria: Gleason score 7 (4+3), PSA 10-20 ng/mL, or clinical stage T2b-T2c)
Planned treatment with SBRT (36.25-37.5 Gy in 5 fractions) and ADT (6 months)
Baseline sexual function assessment available (International Index of Erectile Function [IIEF-5, also known as SHIM] score ≥ 12 or pre-selection erection status score of 1-3: erection insufficient for intercourse, sufficient but not optimal, or normal)
Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Disqualifiers
Prior pelvic radiotherapy, prostate surgery, ADT, or chemotherapy
Pre-existing severe sexual dysfunction (IIEF-5 score < 12 or pre-selection erection status score of 0: no erection)
Hypogonadism at presentation (baseline testosterone below normal range)
Contraindications to SBRT or ADT
Trial design
Treatments tested in this trial
- SBRT combined with ADT
Treatment groups
Sponsors and collaborators
CancerCare Manitoba
Lead sponsor
TerSera Therapeutics LLC
Collaborator