Effectiveness of Posluma PET Scan for Post-Treatment Monitoring of Prostate Cancer

NCT07733908 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: 812089
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

To determine the effectiveness of Posluma PET Scan for monitoring prostate cancer patients after targeted treatment, including how accurately it can detect any remaining or returning cancer after about 12 months post-treatment.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Diagnostic performance of Posluma PSMA PET scan for prostate cancer after focal therapy

  To determine the sensitivity and specificity of the Posluma PSMA PET scan in detecting residual or recurrent prostate cancer lesions approximately 12 months after focal therapy, compared to MRI and biopsy data.

  12 months

• Accuracy of Posluma PSMA PET Imaging for Detection of Residual and Recurrent Disease for Prostate Cancer

  To evaluate whether Posluma PSMA PET imaging can accurately detect residual or recurrent disease measured by comparison with MRI and biopsy results

  12 months

Study Arms (1)

Posluma PET

EXPERIMENTAL

Participants will undergo Posluma PSMA PET scans at two time points: preoperatively to evaluate the extent of disease prior to focal therapy and postoperatively for monitoring treatment success and detecting potential recurrence. The Posluma PET imaging will be conducted on a PET/CT scanner with optimized protocols for PCa lesion detection. PET scan data will be analyzed in comparison with MRI and biopsy results. All imaging will be performed at UCSD, ensuring consistent imaging quality and scanner calibration across all patients.

Diagnostic Test: Posluma PET

Interventions

Posluma PET DIAGNOSTIC_TEST

Posluma® (flotufolastat F 18) is an FDA-approved diagnostic PET imaging agent used to detect prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer. It helps pinpoint the location of cancer when metastasis is suspected or when recurrence occurs due to elevated PSA levels.

Posluma PET

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis: Histologically confirmed PCa.
• Risk Profile: Intermediate-risk , organ-confined PCa
• Eligibility for Focal Therapy: Determined to be an appropriate candidate for focal therapy based on clinical evaluation.
• Age: 18 years or older.
• Life Expectancy: Expected survival of at least 10 years.
• Informed Consent: Ability to understand and willingness to sign the informed consent form.

You may not qualify if:

• Previous Treatment: Prior treatment for PCa, including radiation therapy, chemotherapy, focal therapy, or androgen deprivation therapy.
• Severe Comorbid Conditions: Presence of severe comorbid conditions that may interfere with study participation, such as uncontrolled cardiovascular, renal, hepatic, or metabolic diseases.
• Contraindications to Imaging: Known hypersensitivity to components of the Posluma PSMA radiotracer, or inability to undergo PET or MRI imaging due to medical or anatomical constraints (e.g., severe claustrophobia, metallic implants incompatible with MRI).

Sponsors & Collaborators

• Aditya Bagrodia: lead
• Blue Earth Diagnostics: collaborator

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Aditya Bagrodia, MD, FACS

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Translational Research Team

CONTACT

(858) 822-5354; CancerCTO@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 25, 2026
• First Posted: July 29, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: July 29, 2026

Record last verified: 2026-07