PRIAPUS-PCa Study: Stereotactic Body Radiation Therapy (SBRT) and Androgen Deprivation Therapy (ADT) Impact on Sexual Function on Men With Unfavorable Intermediate Risk Prostate Cancer

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-80
SponsorCancerCare Manitoba

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

130 Participants
are divided into 1 treatment group

Sponsors and collaborators

CancerCare Manitoba

Lead sponsor

TerSera Therapeutics LLC

Collaborator