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Can a better scan sharpen radiation for prostate cancer?

NCT ID NCT03762759

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

140 people

The number who actually took part.

Started

May 2019

Expected to finish

May 2030

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Male participants only

Healthy volunteers

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

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

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342, United States

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322, United States

  • Grady Health System

    Atlanta, Georgia, 30303, United States

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