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New PET tracer spots hidden prostate cancer when PSA is low

NCT ID NCT03204123

Diagnosis Sponsor: Memorial Sloan Kettering Cancer Center Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Last updated Aug 27, 2026 · Updated 2 times

Summary

This study tests whether a new radioactive tracer called 68Ga-HBED-CC-PSMA can detect prostate cancer that has returned after initial treatment, even when PSA levels are very low and standard scans show nothing. Men with biopsy-proven prostate cancer who have been treated with surgery or radiation and have a rising PSA are eligible. The goal is to see if this PET scan can locate the cancer so doctors can decide on the best next steps.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
68Ga-HBED-CC-PSMA (a radioactive tracer for PET scans)
What this could lead to
If successful, this imaging method could help doctors find hidden prostate cancer earlier and guide more precise treatment.
What could go wrong
This is a Phase 2 trial, so the tracer's accuracy and safety are still being evaluated. It may not detect all recurrences, and false positives are possible.

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

About 1,171 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2017

Expected to finish

Jun 2027

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: * Biopsy proven adenocarcinoma of the prostate * Initially treated with definitive local therapy (surgery and radiation therapy are the most common treatments, but other treatments are also eligible) * For patients initially treated with surgery, radiation therapy, brachytherapy, or cryotherapy: * PSA ≥ 0.2 ng/mL in at least two consecutive tests within 6 months of date of consent for patients * Note: The most recent PSA value must be within 6 weeks of consent * For patients who have received additional treatment in the recurrent or metastatic setting: ° PSA ≥ 2 ng/ml above the most recent therapy nadir * Age ≥ 18 years * Patient must be able to tolerate PET/CT or PET/MR imaging Exclusion Criteria: * Patient with claustrophobia that would preclude PET/CT or PET/MR imaging or other contraindications to CT imaging.

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Conditions

The condition(s) this trial relates to.

prostate adenocarcinoma prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate adenocarcinoma Prostate cancer

Contacts and locations

Locations

  • Memorial Sloan Kettering Basking Ridge (Consent only)

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Bergen (Consent only )

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Commack (Consent only)

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Monmouth (Consent only)

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau (Consent only)

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Westchester (Consent only)

    Harrison, New York, 10604, United States

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