NCT06560905 Preoperative Planning With PSMA-PET in Melanoma Surgery Trial
| NCT ID | NCT06560905 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Royal Marsden NHS Foundation Trust |
| Condition | Malignant Melanoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 16 participants |
| Start Date | 2025-03-11 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 16 participants in total. It began in 2025-03-11 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Myles Smith
PRINCIPAL INVESTIGATOR
Royal Marsden NHS Foundation Trust
Frequently Asked Questions
Who can join the NCT06560905 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Malignant Melanoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06560905 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06560905 currently recruiting?
Yes, NCT06560905 is actively recruiting participants. Contact the research team at reyhaneh.sadeghzadeh@rmh.nhs.uk for enrollment information.
Where is the NCT06560905 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT06560905 clinical trial?
NCT06560905 is sponsored by Royal Marsden NHS Foundation Trust. The principal investigator is Myles Smith at Royal Marsden NHS Foundation Trust. The trial plans to enroll 16 participants.
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