Precision radiation combo aims to tame High-Risk prostate cancer
NCT ID NCT04465500
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests a combination of hormone therapy, external beam radiation, and MRI-guided internal radiation implants for men with unfavorable-intermediate to very high-risk prostate cancer. The goal is to see if this precise approach causes fewer urinary side effects than standard treatments. Sixty participants will be followed for outcomes like cancer control, quality of life, and survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Combination of external beam radiation therapy (EBRT), MRI-guided high dose-rate (HDR) brachytherapy, and androgen deprivation therapy (ADT)
- What this could lead to
- If successful, this approach could offer a more precise radiation treatment for high-risk prostate cancer with fewer severe side effects.
- What could go wrong
- This is a small, single-center phase 2 trial with only 60 participants, so results may not apply broadly. The combination therapy also carries risks of urinary, bowel, and sexual side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Jan 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.
- 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: 1. Provision of signed and dated informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Male, aged 18 or above. 4. Histologic proven diagnosis of cancer of the prostate up to one year before registration. 5. Unfavorable-intermediate risk, high risk, or very high-risk prostate cancer as determined by the NCCN Guidelines Version 4.2019 (Section 12.4). 6. History and physical exam completed up to 6 months before registration. 7. PSA value \< 50 ng/mL prior to androgen deprivation therapy and up to 12 months before registration. Subjects who do not meet this criteria's timeframe due to extenuating circumstances (i.e. COVID-19 quarantine, changes to their treatment plan, etc) but meet all other eligibility criteria may still be eligible. The PI will review each case and decide 8. ECOG performance status 0 or 1. 9. Pelvic MRI obtained up to 12 months before registration. 10. Candidate for receiving the combination of HDR brachytherapy and EBRT, with or without ADT. The ADT may have begun prior to study enrollment. Exclusion Criteria: 1. Evidence of bone metastases. 2. Diagnosis of a prior invasive malignancy (except for non-melanoma skin cancer), unless the participant has been disease-free for at least 3 years. 3. Patient has had previous radical surgery (prostatectomy) or cryosurgery for prostate cancer. 4. Patient has had previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy. 5. Patient has had prior radiotherapy, including brachytherapy, to the region of this study cancer that would result in overlap of radiation therapy fields. 6. Patient has had previous or concurrent cytotoxic chemotherapy for prostate cancer (prior chemotherapy for different cancer is allowed). 7. Patient has MRI incompatible metallic implant(s) that cannot be removed. 8. The patient has severe or active co-morbidities as defined by the following: * Unstable angina and/or congestive heart failure requiring hospitalization up to 6 months (180 days) before registration * Transmural myocardial infarction up to 6 months (180 days) before registration * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration * Hepatic insufficiency resulting in clinical jaundice and/or coagulation effects or severe liver dysfunction. * Acquired immune deficiency syndrome (AIDS) based upon current CDC definition. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be slightly immunosuppressive. Protocol- specific requirements may also exclude immuno-compromised patients.
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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.
Contacts and locations
Locations
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University of Virginia
Charlottesville, Virginia, 22908, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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