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RecruitingInterventionalPhase 2

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

NCT ID: NCT06617481Sponsor: AdventHealthLast updated: 2024-10-24

Summary

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.

Arms & interventions

  • Drug18F-rhPSMA-7.3 (Posluma)

    PET Scan using Posluma for detection of early recurrence of prostate cancer.

Outcome measures

Primary

  • Cancer Detection Rate

    Patients who undergo at least one rhPSMA-7.3 (18F) PET-scan will be analyzed for the primary endpoint. The malignant lesion detectability rate will be summarized using percentage and 95% confidence interval estimates overall and for those who underwent a single scan or both scans. The diagnostic evaluation aims to identify individuals who are most likely to have an isolated local relapse, as they have the most significant potential for achieving long-term disease control through additional local therapy.

    Time frame: 24 months

Secondary

  • 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

Sex: MaleAge: 18 Years and olderHealthy volunteers: No
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 locations (1)

AdventHealth

Orlando, Florida, 32804

Recruiting
AdventHealth AdventHealth Oncology Research · Contact
407-303-2090CFD.ResearchOncology@AdventHealth.com
Guru Sonpavde, MD, MD · Contact
PET Scan Study to Detect Prostate Cancer in Patients with Early PSA Recurrence | Cancerify