Can a better scan sharpen radiation for prostate cancer?
NCT ID NCT03762759
First seen Aug 07, 2026 · Last updated Sep 03, 2026 · Updated 2 times
Summary
This trial tests whether two different PET/CT tracers—fluciclovine F18 and 68Ga-PSMA—can better guide radiation therapy planning for men with prostate cancer who have a rising PSA after surgery. The goal is to see if one tracer more accurately spots remaining cancer cells, allowing doctors to target radiation more precisely and improve disease-free survival. About 140 participants will be randomly assigned to one of the two tracers, and their outcomes will be compared.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Two radiotracers for PET/CT imaging: fluciclovine F18 and gallium Ga68-labeled PSMA-11
- What this could lead to
- If one tracer proves better at spotting residual cancer, it could lead to more precise radiation planning and improved disease-free survival for men after prostate surgery.
- What could go wrong
- This is a phase 2 trial, so results are preliminary. The tracers may not differ in effectiveness, and imaging accuracy can vary. Radiation therapy carries risks like urinary or bowel 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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140 people
The number who actually took part.
- Started
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May 2019
- Expected to finish
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May 2030
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: * Adenocarcinoma of the prostate, post radical-prostatectomy * Detectable prostate-specific antigen (PSA) * Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0-2 * No definitive findings for skeletal metastasis on technetium 99-m methyl diphosphonate (MDP) or F-18 PET bone scan * No definitive findings of systemic (extrapelvic) metastasis on CT and/or magnetic resonance (MR) scan of abdomen and pelvis * Willingness to undergo pelvic radiotherapy Exclusion Criteria: * Contraindications to radiotherapy (including active inflammatory bowel disease or prior pelvic radiotherapy) * Inability to undergo fluciclovine or Ga-PSMA PET-CT * Definitive findings of systemic metastasis on conventional imaging or biopsy * Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years * Severe acute co-morbidity, defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization in the last 3 months * Transmural myocardial infarction within the last 6 months * 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 * Acquired immune deficiency syndrome (AIDS) based upon current Center for Disease Control (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immunocompromised 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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Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342, United States
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Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
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Grady Health System
Atlanta, Georgia, 30303, 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?