Loading clinical trials...

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 | Clinical Trials | Clareo Health

NOT_YET_RECRUITING

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

NCT07460726•CancerCare Manitoba

View on ClinicalTrials.gov

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.

Detailed Description

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.

Eligibility

Age

18 - 80 years

Sex

MALE

Healthy Volunteers

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).

Locations (1)

Manitoba Prostate Centre

Winnipeg, Manitoba, Canada

Key Dates

Start Date

March 16, 2026

Primary Completion Date

March 16, 2028

Completion Date

December 31, 2029

Last Updated

March 10, 2026

Enrollment

130

ESTIMATED participants

Conditions

Prostate Cancer (Adenocarcinoma)Erectile AbnormalitiesSexual Dysfunction Male

Interventions

SBRT combined with ADT

COMBINATION_PRODUCT

Contacts

Zoe Ignacio, RN, BN (BScN)

CONTACT

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

Trial Targeting Gut Bacterial Androgen Production to Reverse Therapeutic Resistance to Abiraterone in Patients With Metastatic Prostate Cancer

NCT06616597

Prostate Cancer (Adenocarcinoma)Metastatic Prostate Cancer

View study

RECRUITINGNA

PSMA PET for Surveillance After Focal Therapy

NCT07115914

Prostate Cancer (Adenocarcinoma)Prostate Cancer (Diagnosis)+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 10, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Trial Targeting Gut Bacterial Androgen Production to Reverse Therapeutic Resistance to Abiraterone in Patients With Metastatic Prostate Cancer

PSMA PET for Surveillance After Focal Therapy

Dose De-escalation in Prostate Radiotherapy Using an MR-Linac in Two Fractions

Flotufolastat F 18 PET in Men With Very Low PSA Recurrence

68Ga-AAZTA-NI-093 PET/CT: First-in-human Study

Umbilical Cord-Derived Mesenchymal Stem Cell (VCELL 1) for Male Patients With Sexual Deficiency