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

NCT07460726 | Not Yet Recruiting

• 1 other identifier: 1219
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer (Adenocarcinoma); Erectile Abnormalities; Sexual Dysfunction Male

Keywords

Prostate cancer; sexual function; SBRT; ADT

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Proportion of patients with clinically significant (moderate to severe) erectile dysfunction

  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

  Baseline, 3, 9, 15, and 24 months

• Hormonal Domain Score of the Expanded Prostate Cancer Index Composite (EPIC-26)

  Baseline, 3, 9, 15, and 24 months

• Ejaculatory Function Score as Measured by the Male Sexual Health Questionnaire - Ejaculation Scale (MSHQ-ES-8)

  Baseline, 3, 9, 15, and 24 months

• Health-Related Quality of Life Score as Measured by EORTC QLQ-ELD14

  Baseline, 3, 9, 15, and 24 months (for patients >70 years)

Study Arms (1)

Observational

Prostate cancer patients receiving SBRT and ADT

Combination Product: SBRT combined with ADT

Interventions

SBRT combined with ADT COMBINATION_PRODUCT

SBRT combined with Zoladex

Observational

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Favorable and unfavorable intermediate risk prostate cancer patients

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• CancerCare Manitoba: lead
• TerSera Therapeutics LLC: collaborator

Study Sites (1)

Manitoba Prostate Centre

Winnipeg, Manitoba, R3E 0V9, Canada

Location

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MeSH Terms

Conditions

Prostatic Neoplasms; Adenocarcinoma; Erectile Dysfunction

Interventions

Androgen Antagonists

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Zoe Ignacio, RN, BN (BScN)

CONTACT

1-204-787-2955; ccmb_manitoba_prostate_centre_research@cancercare.mb.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 10, 2026
• Study Start: March 16, 2026
• Primary Completion (Estimated): March 16, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

CA (1)