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Recruiting NCT06617481

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

Phase II Interventional Prostate Cancer (Post Prostatectomy)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 18F-rhPSMA-7.3 (Posluma).
Who it may be relevant to
Registry conditions: Prostate Cancer (Post Prostatectomy). Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

This is not an investigational study drug. 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. In this research study, the flotufolastat-PET scan will be repeated if the initial scan does not show cancer and if PSA further rises by greater than 0.1 ng/ml. Other currently used scans for this purpose do not detect cancer in all patients with low levels of rising PSA.

Interventions

  • Drug 18F-rhPSMA-7.3 (Posluma)
    PET Scan using Posluma for detection of early recurrence of prostate cancer.

Primary outcome measures

  • Cancer Detection Rate [Time frame: 24 months]
Secondary outcome measures (4)
  • Correlation with biopsy [Time frame: 24 months]
  • Correlation with other imaging modalities [Time frame: 24 months]
  • Response to therapy [Time frame: 24 months]
  • Adverse Events [Time frame: 24 hours]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • AdventHealth — Orlando

Identifiers

NCT: NCT06617481 · AdventH · IRBNet # 2067493

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗