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.
This study examines how two standard combination treatment for prostate cancer - a highly targeted form of radiation called Stereotactic Body Radiation Therapy (SBRT) and a hormone-blocking treatment called Androgen Deprivation Therapy (ADT) - impact sexual function in men with unfavorable intermediate risk prostate cancer. Participants will complete study questionnaires before treatment or Baseline, and after treatment, on Month 3, 9, 15, and 24.
Study Type
OBSERVATIONAL
Enrollment
130
SBRT combined with Zoladex
Manitoba Prostate Centre
Winnipeg, Manitoba, Canada
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)
Time frame: Baseline, 3, 9, 15, and 24 months post-SBRT
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
Time frame: Baseline, 3, 9, 15, and 24 months
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)
Time frame: Baseline, 3, 9, 15, and 24 months
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)
Time frame: Baseline, 3, 9, 15, and 24 months
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)
Zoe Ignacio, RN, BN (BScN)
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Time frame: Baseline, 3, 9, 15, and 24 months
Health-Related Quality of Life Score as Measured by EORTC QLQ-ELD14
Measurement Tool: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Elderly Module (EORTC QLQ-ELD14) Unit of Measure: Standardized subscale scores (0-100 scale): Functional scales (higher = better functioning) Symptom scales (higher = greater symptom burden)
Time frame: Baseline, 3, 9, 15, and 24 months (for patients >70 years)