Precision radiation offers new hope for recurrent prostate cancer
NCT ID NCT03312972
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests a focused radiation technique called HDR brachytherapy for men whose prostate cancer has come back after earlier radiation treatment. The radiation is placed directly into the cancerous area and removed after a short time, aiming to spare healthy tissue. The trial will enroll 50 participants to check how safe and effective this approach is.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HDR brachytherapy (high-dose-rate radiation implant)
- What this could lead to
- If successful, this could offer a targeted, less invasive treatment option for men whose prostate cancer has come back after initial radiation therapy.
- What could go wrong
- This is an early-phase trial with only 50 participants, so results may not apply to everyone. There is a risk of side effects from radiation, and the treatment may not control the cancer long-term.
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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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2017
- Expected to finish
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Jul 2026
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: * Biopsy proven locally recurrent adenocarcinoma of the prostate after the completion of definitive radiation therapy for initially diagnosed prostate cancer. * Biopsy must be performed within 182 days of trial registration * Biopsy should be a standard sextant biopsy AND either a targeted MR/ultrasound guided biopsy or saturation biopsy or both. * Initial cancer diagnosis that fits these specific criteria: * Stages T1-T3a * Nx or N0 * Mx or M0 * Eligible initial definitive radiotherapy modalities include: * External beam radiotherapy, with photon or proton beam therapy * Conventional or moderately hypofractionated radiotherapy * Extremely hypofractionated external beam radiotherapy (Stereotactic body radiation therapy) * Definitive Brachytherapy: * Low-dose rate * High-dose rate * Locally recurrent disease confined to the prostate +/- seminal vesicles and immediately adjacent tissue, as evaluated by the following: * History/Physical examination * Radiographically node negative disease (N0), as defined by CT or MR of pelvis +/- abdomen within 6 months of registration. * No evidence of bone metastases (M0) on bone scan within 6 months of registration. * Fluciclovine-PET is encouraged, but not required * Patients receiving ADT are eligible as long as they meet the other eligibility criteria. However, the duration of all ADT must be documented. * Current ECOG Performance status Scale 0-2 * Current International Prostate Symptom Score (IPSS) \< 20 * The patient must be medically suitable to receive general anesthesia. * The patient must be able and willing to sign a study-specific written informed consent form before study entry. Exclusion Criteria: * Preregistration GI or GU toxicity (for any reason) grade ≥ 3 as defined in CTCAE version 4.03. That is, grade ≥ 3 GU or GI toxicity after first course of radiotherapy * Patients receiving any other investigational agents. * Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, severely symptomatic congestive heart failure, cardiac arrhythmia, recent myocardial infarction in last 6 months, or psychiatric illness/social situations that could limit compliance with study requirements. * Patients who have received chemotherapy or immunotherapy within one month prior to study enrollment, other than ADT
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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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Loyola University Medical Center
Maywood, Illinois, 60153, United States
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University of Virginia School of Medicine
Charlottesville, Virginia, 22908, United States
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