RecruitingPhase 2

PET Scan Study to Detect Prostate Cancer in Patients with Early PSA Recurrence

RhPSMA-7.3(18F)-PET Scan to Detect Prostate Cancer in Patients with Early PSA Recurrence

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: PET scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Flotufolastat PET scan is FDA Approved for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy and those with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well a PET scan using flotufolastat F-18 (Posluma), a radioactive imaging drug, can find prostate cancer. It is for people with very low but rising PSA levels after surgery to remove the prostate. PSA is a protein measured in blood to help track prostate cancer.

Flotufolastat F-18, sold under the brand name Posluma, is a radioactive diagnostic agent for use with positron emission tomography (PET) imaging for prostate cancer. The research is being done to study the capability of 18F-rhPSMA-7.3 (flotufolastat F-18) PET scan to detect prostate cancer when there are very low levels of Prostate-Specific Antigen (PSA) following previous radical prostatectomy surgery.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Had adenocarcinoma, a type of prostate cancer, that had not spread beyond the prostate, and had surgery to remove the prostate with the goal of curing it.
  • Have a PSA blood test result of at least 0.1 ng/mL but less than 0.5 ng/mL.

Who can't join

  • Plan to receive an X-ray contrast dye or another radioactive PET imaging drug less than 24 hours before the study scan.
  • Are currently getting androgen deprivation therapy (ADT), a treatment that lowers or blocks male hormones.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * History of localized adenocarcinoma of the prostate with prior curative intent radical prostatectomy. * An elevated PSA test result that is greater than or equal to 0.1 ng/ml and less than 0.5 Exclusion Criteria: * Patients who are planned to have an x-ray contrast agent or other PET radiotracer \& less than 24 hours prior to the flotufolastat F-18 PSMA-PET scan. * Patients currently receiving Androgen Deprivation Therapy (ADT).

Study sites (1)

FL