NCT07460726Not yet recruiting
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
A Single Arm Prospective Study to Investigate the Impact of Stereotactic Body Radiation Therapy (SBRT) and Androgen Deprivation Therapy (ADT) on Sexual Dysfunction in Unfavorable Intermediate Risk Prostate Cancer
Source: ClinicalTrials.gov · Last updated 10 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 130 (estimated)
- First submitted
- 25 Feb 2026
- Start date
- 16 Mar 2026
- Primary completion date
- 16 Mar 2028
- Lead sponsor
- CancerCare Manitoba
- Diseases
- Prostate cancer
- NCT number
- NCT07460726
What you commit to
- Study type: Observational
- Planned participants: 130
- From 16 Mar 2026 to the primary completion date, 16 Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior pelvic radiotherapy, prostate surgery, ADT, or chemotherapy
- Use of medications altering ejaculation (e.g., 5-alpha reductase inhibitors)
Other illness
- Metastatic disease, second malignancy, or previous malignancies.
- Benign or malignant penile diseases.
- Psychiatric conditions affecting questionnaire completion or QoL assessment
- Severe comorbidities affecting QoL assessments (e.g., advanced cardiovascular disease).
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Manitoba Prostate Centre Coordinator of this site? Confirm its status | Winnipeg | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.