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NCT Number: NCT06617481

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

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.

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Key information

Conditions

Prostate Cancer (Post Prostatectomy) Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

AdventHealth

Orlando, Florida, 32804, United States

Location status: Recruiting

Location contact

AdventHealth AdventHealth Oncology Research

CONTACT

[email protected]

407-303-2090

Guru Sonpavde, MD, MD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

18F-rhPSMA-7.3 (Posluma)

Drug

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

Primary outcomes

  1. Cancer Detection Rate

    Time frame: 24 months

    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.

Secondary outcomes

  1. Correlation with biopsy

    Time frame: 24 months

    In those patients who undergo biopsy of a lesion, correlation with pathology report diagnosis will be reviewed.

  2. Correlation with other imaging modalities

    Time frame: 24 months

    In those patients who undergo other imaging modalities to confirm the results of the rhPSMA-7.3 (18F) PET-scan, correlation with other imaging modalities will be reviewed.

  3. Response to therapy

    Time frame: 24 months

    In those patients who undergo cancer directed therapy with radiation alone or with androgen deprivation therapy, the follow-up PSA test values after therapy will be reported.

  4. Adverse Events

    Time frame: 24 hours

    Safety and toxicity data will be collected to evaluate any patient reported adverse effects. Safety Follow-up Call Within 24 hours of each Injection/Scan

Study contacts

Contact information is provided by the study sponsor or research team.

AdventHealth AdventHealth Oncology Research

CONTACT

[email protected]

407-303-2090

Sponsors and collaborators

Lead sponsor

AdventHealth

Other

Collaborators

  • Blue Earth Diagnostics

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 27, 2024
Registry last updated
Oct 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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