Prostate cancer recurrence study pulled before it even started
NCT ID NCT04645810
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aimed to test a focused radiation treatment (HDR brachytherapy) for men whose prostate cancer returned only in the prostate gland after earlier radiation therapy. It planned to enroll adults with biopsy-confirmed recurrence seen on a special PET scan. However, the study was withdrawn before any participants were enrolled, so no results are available.
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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.
- Started
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Oct 2021
- Finished
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Aug 2025
- 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: History of histologically confirmed, clinically localized adenocarcinoma of the prostate treated with external beam radiation, brachytherapy, or combination of external beam radiation and brachytherapy, with curative intent completed at least 24 months ago F-18 fluciclovine (AXUMIN) PET scan within 90 days prior to registration demonstrating recurrent lesion within the prostate gland Biopsy confirmation of disease recurrence within the prostate gland Age ≥ 18 KPS ≥ 70% Suitable candidate for brachytherapy based on established criteria IPSS score \<16 No pelvic arch interference No Rectal fistula/fissure Fit for general or spinal anesthesia No history of urethral stricture Ability to understand, and willingness to sign the written informed consent Exclusion Criteria: Evidence of metastatic or nodal disease outside of the prostate gland on AXUMIN PET scan within 90 days prior to enrollment Patient unable to have MRI Patients with neuroendocrine or small cell carcinoma of the prostate TURP within 6 months prior to enrollment History of Crohn's disease, ulcerative colitis, or known radiation proctitis Inability to understand spoken and written English
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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 Rochester
Rochester, New York, 14642, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- 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