New PET scan agent aims to map hidden prostate cancer spread

NCT ID NCT04716725

What the study statuses mean

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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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 ยท Last updated Jun 27, 2026

Summary

This study tested a new imaging agent called 68Ga-PSMA-11 to see if it could give clearer pictures of where prostate cancer has spread in men with advanced, treatment-resistant disease. The goal was to help doctors better understand the location of tumors. The study was terminated early and enrolled only 15 participants.

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

15 people

The number who actually took part.

Started

Sep 2021

Finished

Apr 2025

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: 1. Sub-cohort A1: Patients must have baseline evaluations performed within 12 weeks prior to the start of systemic therapy. 2. Sub-cohort A2: Patients must meet all the following requirements: * Have had a baseline pre-treatment 68Ga-PSMA-11 PET scan and PSA measurement performed within 12 weeks prior to the start of current systemic therapy. * Able to have an on-treatment 68Ga-PSMA-11 PET and a PSA measurement within 16 weeks (+/- 8 weeks) after the start of current systemic therapy. Note: The screening period for sub-cohort A2 is within 24 weeks after the patient started their current systemic therapy. 3. Patients must have progressive castration resistant prostate cancer, according to PCWG3 criteria. 4. Patients must have planned initiation of systemic treatment (sub-cohort A1), or ongoing systemic treatment (sub-cohort A2) for castration resistant prostate cancer within 12 weeks of baseline Ga-PSMA PET. 5. Patients must have at least one metastatic lesion with PSMA uptake at or above the blood pool on their baseline PSMA PET scan. 6. The patient must be able and willing to comply with study procedures and provide signed and dated informed consent. 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 8. Patient must be Aged 18 years or older at the time of study entry. 9. Patients who undergo optional metastatic tumor biopsy following completion of baseline Ga-PSMA PET must additionally meet all of the following criteria: * Presence of one or more metastases by standard radiographic scans that is safely accessible to tumor biopsy in the judgment of treating clinician and/or Interventional Radiology. * No history of radiation therapy to the target metastatic lesion selected for tumor biopsy. * No contra-indication to biopsy including uncontrolled bleeding diathesis. * Platelets \> 75,000/ul and prothrombin time (PT) or institution normalized ratio (INR) and a partial thromboplastin time (PTT) \< 1.5 times the institutional upper limit of normal (ULN) within 14 days prior to biopsy. Exclusion Criteria: 1. Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent. 2. Patients with any condition that, in the opinion of the Principal Investigator, would impair the patient's ability to comply with study procedures. 3. Patients with any contra-indication to magnetic resonance imaging (MRI) (e.g. pacemaker placement, severe claustrophobia) Note: The exclusion criteria above (3) is only applicable for patients scheduled for a Positron Emission Tomography (PET) MRI (PET/MRI).

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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

  • University of California San Francisco

    San Francisco, California, 94143, United States

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