Preoperative planning PSMA-PET in Melanoma Surgery (PPPIMS)
| ISRCTN | ISRCTN20735014 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20735014 |
| EudraCT/CTIS number | 2022-001208-16 |
| IRAS number | 1005470 |
| ClinicalTrials.gov number | NCT06560905 |
| Secondary identifying numbers | CCR5614, IRAS 1005470 |
- Submission date
- 02/09/2023
- Registration date
- 26/09/2024
- Last edited
- 02/07/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
This study is investigating the ability of a new diagnostic biomarker, prostate-specific membrane antigen (PSMA), to detect melanoma metastases using a PSMA PET/CT scan.
Who can participate?
Patients aged 18 years and over with operable advanced metastatic melanoma
What does the study involve?
Patients will undergo the standard preoperative scans determined by the consultant; either whole-body PET/CT or FDG-PET/CT and MRI brain, with the addition of the PSMA PET/CT scan, investigating the presence of metastases. The patients will then undergo surgery determined by the patient’s consultant.
The PSMA-PET scans will be carried out in the Nuclear Medicine Department at the Royal Marsden Hospital and interpreted by a Consultant Radiologist with a special interest in Nuclear Medicine. These will be compared to the standard-of-care scans. If there is no PSMA activity identified by the first five patients, the researchers will terminate the trial.
What are the possible benefits and risks of participating?
It can be a distressing time for potential patients in a regular outpatient consultation in terms of understanding diagnosis and treatment decisions. Being approached about the study and having to make a decision to participate in research may further distress at this time. In order to minimise this risk, the study information will be given and informed consent sought by an experienced member of the surgical melanoma team trained in the study protocol and GCP. Furthermore, the melanoma surgery team are highly experienced in discussing research and seeking consent from patients newly diagnosed with cancer and are sensitive to the risks involved.
Patients will be required to have an intravenous injection of the radiotracer 68Ga-PSMA-11. 68Ga-PSMA-11 is a radioactive compound and exposure to high levels of radioactivity is associated with an increased risk of cancer. PSMA PET will give a dose of 4.6 mSv and standard-of-care FDG-PET will give 7.6 mSV; slightly less and similar to chest CT at 7 mSV respectively and around double the yearly average exposure to background radiation.
Prospective Phase I trials show 68Ga-PSMA-11 to be safe with no serious adverse reactions 1 and it was approved by the FDA in December 2020. The most commonly reported side effects were nausea, diarrhoea, and dizziness, occurring at a rate of <1%.
There is a risk for misdiagnosis because Ga 68 PSMA-11 binding may occur in other types of cancer as well as certain non-malignant processes which may lead to image interpretation errors. These scans will be interpreted by a Consultant Radiologist and will be compared with the standard-of-care scans. If necessary, a biopsy can be taken to ensure disease. This is also standard of care.
Patients will undergo both a standard-of-care baseline scan and a PSMA-PET scan. This results in one extra dose of radiation due to the additional scan. Exposure to a higher level of radioactivity is associated with an increased risk of cancer. This is also why there is an early limit on the number of patients undergoing the trial if no positive results are found. However, if the PSMA scan is able to detect metastases, the benefits of delivering the most effective and patient-specific treatment will outweigh the extra dose of radiation.
Where is the study run from?
Royal Marsden NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
September 2023 to December 2025
Who is funding the study?
BRC Pump Priming (UK)
Who is the main contact?
Dr Myles Smith, myles.smith@rmh.nhs.uk
Contact information
Public, Scientific, Principal Investigator
The Royal Marsden Hospital
Fulham Road
London
SW3 6JJ
United Kingdom
 ORCID ID |
0000-0002-3254-4817 |
|---|---|
| myles.smith@rmh.nhs.uk |
Study information
| Study design | Non-randomized single-centre Phase II CTIMP trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Preoperative planning PSMA-PET in Melanoma Surgery (PPPIMS) |
| Study acronym | PPPIMS |
| Study objectives | The main objective is to investigate whether the diagnostic biomarker, prostate-specific membrane antigen (PSMA), can detect metastatic disease in melanoma patients using a PSMA PET/CT The secondary objective is to compare FDG PET/CT in identifying known metastases with PSMA PET/CT |
| Ethics approval(s) |
Approved 09/08/2024, South Central – Hampshire B REC (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8088; hampshireb.rec@hra.nhs.uk), ref: 23/LO/0807 |
| Health condition(s) or problem(s) studied | Metastatic melanoma |
| Intervention | Within the 2 weeks prior to surgery, all patients will undergo both PSMA PET-CT and FDG PET-CT scans at least 48 hours apart. The Investigational Medicinal Product (IMP) under investigation in this trial is 68Ga-PSMA (gozetotide). This is an imaging radionuclide tracer and is in chemical form. Up to 200 MBq. The route of administration is intravenous. Follow-up duration is 4-6 weeks after surgery per standard of care. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Gozetotide |
| Primary outcome measure | 1. Proportion of successes for detecting metastatic disease by PSMA PET-CT, measured at a single timepoint before surgery |
| Secondary outcome measures | 1. Proportion of successes for detecting metastatic disease by both PSMA PET-CT and FDG PET-CT, measured at a single timepoint before surgery 2. The Standardised Uptake Value (SUV) by both FDG PET-CT and PSMA PET-CT, measured at a single timepoint before surgery |
| Overall study start date | 02/09/2023 |
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | 16 |
| Key inclusion criteria | 1. Males ≥18 years of age 2. 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 |
| Key exclusion criteria | 1. Patients unable to give voluntary written informed consent to participate in this study 2. Patients not willing to complete all the study assessments 3. Patients who are females 4. Patients who are taking androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists 5. Patients who have or have previously been diagnosed with prostate cancer 6. Patients who have had Lu-177 PSMA therapy or barium studies within a period of 10 days prior to undergoing PSMA PET-CT scanning 7. Patients not fluent in English |
| Date of first enrolment | 01/03/2025 |
| Date of final enrolment | 01/12/2025 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
United Kingdom
Sponsor information
Hospital/treatment centre
Fulham Road
London
SW3 6JJ
England
United Kingdom
| Phone | +44 (0)20 3186 5416 |
|---|---|
| Reyhaneh.SadeghZadeh@rmh.nhs.uk | |
| Website | http://www.royalmarsden.nhs.uk/pages/home.aspx |
"ROR" |
https://ror.org/0008wzh48 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 01/04/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | 1. Peer-reviewed scientific journals 2. Internal report 3. Conference presentation 4. Publication on website 5. Other publication |
| IPD sharing plan | Data obtained through this study may be provided to qualified researchers with academic interest in Melanoma biomarkers. Data or samples shared will be coded, with no patient health information included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Data requests can be submitted starting 3 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). |
Editorial Notes
02/07/2025: The overall study start date was changed from 01/07/2023 to 02/09/2023.
01/07/2025: The completion date was changed from 01/12/2025 to 31/12/2025.
28/01/2025: The following changes were made:
1. The intention to publish date was changed from 01/07/2024 to 01/04/2026.
2. The recruitment start date was changed from 15/01/2025 to 01/03/2025.
20/11/2024: The recruitment start date was changed from 15/11/2024 to 15/01/2025.
24/08/2024: ISRCTN received notification of combined HRA/MHRA approval for this trial on 24/08/2024.
04/09/2023: Study's existence confirmed by the HRA.
