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
Prostate Cancer (Adenocarcinoma)Erectile AbnormalitiesSexual Dysfunction Male
Investigational drug(s) / intervention(s)
SBRT combined with ADT
SBRT combined with ADT: SBRT combined with Zoladex
Study 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.
Eligibility
Sex
MALE
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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).
Primary outcome measure(s)
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. — Baseline, 3, 9, 15, and 24 months post-SBRT Outcome Measure Title:
Change in Erectile Function Score as Measured by the International Index of Erectile Function-5 (IIEF-5 / SHIM)
Measurement Tool:
International Index of Erectile Function-5 (IIEF-5, also known as SHIM)
Unit of Measure:
Total IIEF-5 score (range 1-25; higher scores indicate better erectile function)
Derived Unit:
Change in IIEF-5 score from baseline to 24 months (continuous variable, points)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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