Prostate cancer Treatment's hidden cost: study tracks sexual side effects
NCT ID NCT07460726
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study follows 130 men with unfavorable intermediate-risk prostate cancer to see how a combination of targeted radiation (SBRT) and 6 months of hormone therapy (ADT) impacts their sexual function. Researchers measure erectile function before treatment and again after 24 months using a standard questionnaire. The goal is to better understand and manage sexual side effects, helping men make informed treatment decisions.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 130 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Favorable and unfavorable intermediate risk prostate cancer patients
- Ages
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18 to 80 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Manitoba Prostate Centre
Winnipeg, Manitoba, R3E 0V9, Canada
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Other studies related to the condition(s) this trial covers.
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