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
Starting soon
Conditions studied: Prostate Cancer (Adenocarcinoma), Erectile Abnormalities, Sexual Dysfunction Male
In brief
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.
Key facts
- Study ID
- NCT07460726
- Run by
- CancerCare Manitoba
- People needed
- 130
- Starts
- 2026-03-16
- Expected to finish
- 2029-12-31
- Last updated by the study team
- 2026-03-10
Who can join
Age: 18 and older, up to 80. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- Written informed consent to participate.
You may not qualify if…
- 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
- Metastatic disease, second malignancy, or previous malignancies.
- Benign or malignant penile diseases.
- Use of medications altering ejaculation (e.g., 5-alpha reductase inhibitors)
- Psychiatric conditions affecting questionnaire completion or QoL assessment
- Severe comorbidities affecting QoL assessments (e.g., advanced cardiovascular disease).
Where it is running
- Manitoba Prostate Centre — Winnipeg, Manitoba, Canada
Full record on ClinicalTrials.gov
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