Effectiveness of Posluma PET Scan for Post-Treatment Monitoring of Prostate Cancer
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: Posluma PET.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. 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
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Posluma PET Scan in Evaulation and Monitoring of Patients Undergoing Focal Therapy for Prostate Cancer
Overview
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 test Posluma 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.
Primary outcome measures
- Diagnostic performance of Posluma PSMA PET scan for prostate cancer after focal therapy [Time frame: 12 months]
- Accuracy of Posluma PSMA PET Imaging for Detection of Residual and Recurrent Disease for Prostate Cancer [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07733908 · 812089