New Scan-Guided therapy could delay hormone therapy for prostate cancer patients
NCT ID NCT04175431
First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times
Summary
This study is for men with prostate cancer that has returned after surgery and radiation, but only shows up in a few places on a special PET scan. The goal is to treat those specific spots with targeted therapy, which may help control the cancer and delay the need for long-term hormone therapy. About 100 participants will be followed to see if their PSA levels drop below 0.2 ng/mL after treatment.
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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 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2020
- Expected to finish
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Jul 2037
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: * Patient must have histologically or cytologically documented evidence of prostate adenocarcinoma * Patient must previously have undergone radical prostatectomy * Patient must previously have undergone either adjuvant or salvage radiation therapy to the prostatic fossa +/- whole pelvis * Patient must have a prostate specific antigen (PSA) \>= 0.2 and \< 10 ng/mL. If there is only one PSA value that has risen to \>= 0.2 with this biochemical recurrence, a second PSA value must be confirmed to be within \>= 0.2 and \< 10 ng/mL at least 2 weeks from the first value and within 28 days of enrollment * PSA doubling time must be calculated utilizing either all PSA measurements \> 0.1 ng/mL from most recent biochemically-recurred (BCR) or the most recent 3 PSA measurements \> 0.1 ng/mL (if the latter, all 3 PSA measurements must be \> 2 weeks apart to be used in the calculation). PSA doubling time must be \> 3 months and \< 18 months. The Memorial Sloan Kettering PSA doubling time calculator should be used * Patient must have no previous evidence of radiographically detectable metastatic prostate cancer by conventional CT and bone scan imaging * Patient must have total testosterone level \> 120 ng/dL demonstrated within 42 days of enrollment * Patient must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Absolute neutrophil count (ANC) \>= 1.0 X 10\^9/L * Platelet count \>= 100 X 10\^9/L * Hemoglobin \>= 9 g/dL * Potassium \>= 3.5 * Serum bilirubin =\< 1.5 X upper limit of normal (ULN) or =\< 3 X ULN for patients with documented Gilbert's syndrome * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 X ULN * Creatinine clearance (Cr Cl) \>= 30 mL/min as estimated by the Cockcroft-Gault criteria or as determined by 24 hour Cr Cl measurement * Patient must be \>= 18 years of age on day of signing informed consent * Patient must be able to understand and authorize informed consent Exclusion Criteria: * Chronic active hepatitis B or C * History of a second, non-prostate malignancy that required systemic therapy in the last 2 years except cancer in situ of bladder and non-melanomatous cancers of the skin * Patient with a serious underlying medical condition that would otherwise impair the patient's ability to undergo fluciclovine or PSMA PET/CT imaging or receive subsequent treatment * Any condition that would alter the patient's mental status, prohibiting understanding and/or authorization of informed consent * Expected lifespan of less than 12 weeks * Inability to lay still for imaging * Weight \> 300 lbs. (due to equipment specifications) * Any other underlying medical condition that, in the opinion of the investigator, would impair the ability of the patient to receive or tolerate the planned treatment and/or follow up
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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
2 sites. 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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Fred Hutch/University of Washington Cancer Consortium
RECRUITINGSeattle, Washington, 98109, United States
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University of Pittsburgh Cancer Institute (UPCI)
RECRUITINGPittsburgh, Pennsylvania, 15232, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new PET tracer spot hidden prostate cancer spread?
- Can a radioactive tracer and MRI reveal prostate Cancer's true extent?
- Can a One-Two radiation punch improve prostate cancer control?
- Can a special PET scan change the course of prostate cancer?
- Can a High-Tech radiation beam hit prostate tumors without harming healthy tissue?
- Can 3D imaging make prostate radiation more precise and worth the cost?