Clinical trial · Observational
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
NCT07460726CI-TRIAL-00105102PRIAPUS-PCanot yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Erectile Abnormalities | — | UNRESOLVED | — |
| Prostate Cancer (Adenocarcinoma) | Malignant Prostate Neoplasm | CURATED_EXACT | 0.85 |
| Sexual Dysfunction Male | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SBRT combined with ADT | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational
- description
- Prostate cancer patients receiving SBRT and ADT
- interventionNames
- Combination Product: SBRT combined with ADT
Primary outcomes (1)
- measure
- 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
- description
- 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)
Secondary outcomes (5)
- measure
- Proportion of patients with clinically significant (moderate to severe) erectile dysfunction
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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).
References
Publications (45)
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- Alayed Y, Davidson M, Quon H, Cheung P, Chu W, Chung HT, Vesprini D, Ong A, Chowdhury A, Liu SK, Panjwani D, Helou J, Musunuru HB, Pang G, Korol R, Ravi A, McCurdy B, Zhang L, Mamedov A, Deabreu A, Commisso A, Commisso K, D'Alimonte L, Ho L, Bhounr Z, Loblaw A. Dosimetric predictors of toxicity and quality of life following prostate stereotactic ablative radiotherapy. Radiother Oncol. 2020 Mar;144:135-140. doi: 10.1016/j.radonc.2019.11.017. Epub 2019 Dec 3.