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NCT Number: NCT07733908

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 12 months

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

Study contacts

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

Translational Research Team

CONTACT

[email protected]

(858) 822-5354

Sponsors and collaborators

Lead sponsor

Aditya Bagrodia

Other

Collaborators

  • Blue Earth Diagnostics

Registry information

Official study title

Efficacy of Posluma PET Scan in Evaulation and Monitoring of Patients Undergoing Focal Therapy for Prostate Cancer

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jul 29, 2026
Registry last updated
Aug 14, 2026

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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