PRIAPUS-PCa Study: Stereotactic Body Radiation Therapy (SBRT) and Androgen Deprivation Therapy (A… (NCT07460726) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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
Canada130 participantsStarted 2026-03-16
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexMALE
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Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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).
What they're measuring
1
Change in erectile dysfunction severity from baseline to 24 months, as measured by the change in International Index of Erectile Function 5-item version (IIEF-5) score.
Timeframe: Baseline, 3, 9, 15, and 24 months post-SBRT