Preoperative Planning With PSMA-PET in Melanoma Surgery Trial

Phase 2

Not yet recruiting

• Conditions: Malignant Melanoma
• Interventions: Drug: 68Ga-PSMA

• Registration Number: NCT06560905
• Lead Sponsor: Royal Marsden NHS Foundation Trust

Brief Summary

This is a non-randomised, single-centre Phase 2 study, investigating whether the diagnostic biomarker, prostate-specific membrane antigen (PSMA), can detect melanoma metastases using PSMA PET/ CT.

Detailed Description

Our proposed 'Preoperative Planning PSMA-PET in Melanoma Surgery (PPPIMS)' trial is a Phase 2 study, investigating the ability of PSMA as a biomarker to accurately detect melanoma metastases in patients with palpable lymphadenopathy and oligometastatic melanoma. If proven to have diagnostic utility, it may allow more precise 3D lymphatic mapping and identification of tumour in intricate anatomical areas, resulting in more accurate surgical planning. A more precise delineation of nodal disease and metastasis will result in a more accurate and lesser surgical dissection, and consequent reduction in morbidity.

We will also compare the PSMA-PET-CT with standard-of-care imaging, FDG-PET-CT to evaluate utility of this approach. It is of note that FDG-PET CT has a high background FDG uptake normally seen in the brain and liver, and PSMA could potentially be a more favourable tracer if there is less background uptake.

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-15
• Study First Submitted QC: 2024-08-15
• Last Update Submitted: 2024-08-15
• Study First Posted: 2024-08-19
• Last Update Posted: 2024-08-19
• Study Start: 2024-09-01
• Primary Completion: 2025-08-01
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

• Males ≥18 years of age
• Biopsy proven first and recurrent metastatic melanoma with palpable nodal disease who have undergone a staging FDG PET-CT scan as part of routine clinical care and are scheduled for surgery for resection of the primary site

Exclusion Criteria

• Patients unable to give voluntary written informed consent to participate in this study
• Patients not willing to complete all the study assessments
• Patients who are females
• Patients who are taking androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists.
• Patients who have or have previously been diagnosed with prostate cancer
• Patients who have had Lu-177 PSMA therapy or barium studies within a period of 10 days prior to undergoing PSMA PET-CT scanning
• Patients not fluent in English

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PSMA PET-CT	68Ga-PSMA	Within the two weeks prior to surgery, the patients will undergo both PSMA PET-CT \& FDG PET-CT scans at least 48 hours apart. The Investigational Medicinal Product (IMP) under investigation in this trial is 68Ga-PSMA. This is an imaging radionuclide tracer.

Primary Outcome Measures

Name	Time	Method
PSMA PET-CT detection of melanoma metastases	1 Year	The principal objective of the study is to investigate whether the diagnostic biomarker, prostate-specific membrane antigen (PSMA), can detect melanoma metastases using a PSMA PET/ CT.

Secondary Outcome Measures

Name	Time	Method
Compare FDG PET-CT & PSMA PET-CT	1 Year	1. To compare FDG PET-CT in identifying known metastasis with PSMA PET-CT; 2. To compare the radiological information obtained by FDG PET-CT and PSMA PET-CT