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.
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.
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
Favorable and unfavorable intermediate risk prostate cancer patients
Cohort
Prospective
SBRT combined with ADT
Combination productSBRT combined with Zoladex
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.
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)
Proportion of patients with clinically significant (moderate to severe) erectile dysfunction
Measurement Tool: IIEF-5 (SHIM) Unit of Measure: Percentage (%) of patients with IIEF-5 score ≤ 11
Change in sexual function, as measured by the Expanded Prostate Cancer Index Composite 26-item version (EPIC-26) sexual domain score
Measurement Tool: EPIC-26 Questionnaire - Sexual Domain Unit of Measure: Standardized domain score (0-100 scale; higher scores indicate better sexual function)
Hormonal Domain Score of the Expanded Prostate Cancer Index Composite (EPIC-26)
Measurement Tool: EPIC-26 Questionnaire - Hormonal Domain Unit of Measure: Standardized domain score (0-100 scale; higher scores indicate better hormonal function)
Ejaculatory Function Score as Measured by the Male Sexual Health Questionnaire - Ejaculation Scale (MSHQ-ES-8)
Measurement Tool: Male Sexual Health Questionnaire - Ejaculation Scale (ES-8) Unit of Measure: Total ES-8 score (range 3-40; higher scores indicate worse ejaculatory function)
Click on the lead sponsor to view all of their trials.
CancerCare Manitoba
Lead sponsor
TerSera Therapeutics LLC
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
