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| Name | Class |
|---|---|
| TerSera Therapeutics LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | Prostate cancer patients receiving SBRT and ADT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBRT combined with ADT | Combination Product | SBRT combined with Zoladex |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline, 3, 9, 15, and 24 months post-SBRT |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Favorable and unfavorable intermediate risk prostate cancer patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zoe Ignacio, RN, BN (BScN) | Contact | 1-204-787-2955 | ccmb_manitoba_prostate_centre_research@cancercare.mb.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manitoba Prostate Centre | Winnipeg | Manitoba | R3E 0V9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
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Measurement Tool: EPIC-26 Questionnaire - Sexual Domain Unit of Measure: Standardized domain score (0-100 scale; higher scores indicate better sexual function) |
| 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) | 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) | 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) | Baseline, 3, 9, 15, and 24 months (for patients >70 years) |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D000230 | Adenocarcinoma |
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D012735 | Sexual Dysfunction, Physiological |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000726 | Androgen Antagonists |
| ID | Term |
|---|---|
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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