Prostate Cancer
Conditions
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.
Detailed description
This Phase II study will employ Posluma PSMA PET scans both preoperatively, for evaluation of lesions prior to focal therapy, and postoperatively, for monitoring recurrence and verifying treatment success. Imaging findings from Posluma PET will be compared with standard MRI and biopsy results to validate Posluma PET as an advanced diagnostic tool for improving PCa detection in patients undergoing focal therapy as well as postoperative follow-up after the procedure.
Interventions
DIAGNOSTIC_TESTPosluma PET
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.
Sponsors
Aditya Bagrodia
Blue Earth Diagnostics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosis: Histologically confirmed PCa. 2. Risk Profile: Intermediate-risk , organ-confined PCa 3. Eligibility for Focal Therapy: Determined to be an appropriate candidate for focal therapy based on clinical evaluation. 4. Age: 18 years or older. 5. Life Expectancy: Expected survival of at least 10 years. 6. Informed Consent: Ability to understand and willingness to sign the informed consent form.
Exclusion criteria
1. Previous Treatment: Prior treatment for PCa, including radiation therapy, chemotherapy, focal therapy, or androgen deprivation therapy. 2. Severe Comorbid Conditions: Presence of severe comorbid conditions that may interfere with study participation, such as uncontrolled cardiovascular, renal, hepatic, or metabolic diseases. 3. 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic performance of Posluma PSMA PET scan for prostate cancer after focal therapy | 12 months | 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. |
| Accuracy of Posluma PSMA PET Imaging for Detection of Residual and Recurrent Disease for Prostate Cancer | 12 months | To evaluate whether Posluma PSMA PET imaging can accurately detect residual or recurrent disease measured by comparison with MRI and biopsy results |
Contacts
CONTACTTranslational Research Team
PRINCIPAL_INVESTIGATORAditya Bagrodia, MD, FACS
University of California, San Diego
Outcome results
None listed