New combo treatment targets returned prostate cancer
NCT ID NCT03553602
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a treatment for prostate cancer that came back after previous radiation. It combined temporary radioactive implants placed in the prostate, daily external radiation to the pelvis for 5 weeks, and 6 months of hormone therapy. The goal was to see if this approach could control the cancer and what side effects might occur. Only 3 people took part before the study was stopped early.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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3 people
The number who actually took part.
- Started
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Dec 2017
- Finished
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Jul 2024
- 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 to 99 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 * Biopsy proven locally recurrent adenocarcinoma of the prostate after the completion of definitive radiation therapy for initially diagnosed prostate cancer. * Initial cancer diagnosis that fits these specific criteria: * Stages cT1-T3a * Nx or N0 * Mx or M0 * Eligible initial definitive radiotherapy modalities include: * External beam radiotherapy, with photon or proton beam therapy * Definitive Brachytherapy * Stereotactic Body Radiotherapy * Fluciclovine-positive pelvic nodes (as determined by an interpreting radiologist or nuclear medicine physician) in the pelvic nodal region (defined as the pelvic nodal regions up to the common iliac nodal region) without any evidence of lymph node involvement outside of this area or distant metastases * Candidate for hormonal therapy. * Current ECOG Performance status Scale 0-2 (Appendix D) * Current International Prostate Symptom Score (IPSS) \< 20 (Appendix B) * Age \>18 * The patient must be medically suitable to receive general or spinal anesthesia. * AST, ALT, and alkaline phosphatase \< 2 x upper institutional limit within 3 months of registration. * The patient must be able and willing to sign a study-specific written informed consent form before study entry. Exclusion Criteria * Preregistration radiation-related 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 * Treatment to a "whole pelvis" field with initial radiotherapy * Patients with distant metastases (such as to the bone, visceral organs, and lymph nodes other than the pelvic nodes including the common iliac nodes). * 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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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