New Imaging-Guided radiation aims to better control High-Risk prostate cancer
NCT ID NCT07291557
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether using PSMA-PET scans to guide radiation therapy can improve cancer control in men with high-risk prostate cancer that hasn't spread to lymph nodes. About 250 participants will receive radiation to the prostate and nearby tissues, with or without whole pelvis radiation. The goal is to see if this approach reduces the chance of cancer returning over five years.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 250 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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May 2036
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.
- Ages
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18 years and older
- 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: PSMA-N0M0 patients who have a documented history of High Risk localized adenocarcinoma of the prostate are eligible to participate if they meet the following eligibility criteria: 1. Participants capable of giving written informed consent. 2. Male. 3. Age ≥18 years. 4. ECOG ≤2. 5. Patient has histologically proven adenocarcinoma of prostate gland with an assigned Gleason score and Gleason Grade Group. 6. ≥NCCN High-Risk localized disease as per standard imaging investigations including pelvic imaging (CT, MRI) and 99Tc bone scan. High Risk prostate cancer defined as any of the following: cT3-T4 disease OR PSA ≥20 ng/ml OR Gleason grade group 4 or 5. 7. No documentation of regional nodal (N1) or metastatic (M1) prostate cancer on standard imaging (CT, MRI, or 99Tc bone scan). 8. In the opinion of the treating oncologist, patient is fit to undergo radical external beam radiotherapy to the prostate. 9. Patient commits to androgen suppression treatment as per standard of care. 10. Patient is willing to complete symptom and patient reported outcome questionnaires. 11\. Patients of childbearing / reproductive potential should use highly effective birth control methods, as defined by the investigator, during the study treatment period and for a period of 6 months after the last dose of radiation therapy. A highly effective method of birth control is defined as those that result in low failure rate (i.e. less than 1% per year) when used consistently and correctly. Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard. Male patients should agree to not donate sperm during the study and for 6 months after completion of radiation therapy. Exclusion Criteria: 1. Inability to complete the investigational imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.). 2. Any additional medical condition, serious inter-current illness or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study performance, interpretation, or compliance with radiation 3. Patients who have initiated therapy (ADT, systemic therapy, or radiation) for their prostate cancer prior to PSMA-PET imaging. 4. History of inflammatory bowel disease, anal stenosis, colorectal surgery, or repeated endoscopic examinations/interventions related to anorectal diseases. 5. History of prostatectomy or previous pelvic radiotherapy. 6. Previous malignancy within the last five years, except BCC or SCC skin or a malignancy treated curatively with no evidence of disease for ≥5 years. 7. Bilateral hip prostheses will be ineligible for study
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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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Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Radioactive missile aims at prostate cancer that spread
- New PET tracer targets ACP3 to spot prostate cancer
- Can a One-Week radiation course match four weeks for prostate cancer?
- Can a new PET tracer spot hidden prostate cancer spread?
- Can a gel cushion shield the rectum during prostate radiation?
- A scanner in the operating room could show surgeons exactly where prostate cancer remains