PSMA Imaging - Version 1.0
Research type
Research Study
Full title
Evaluation of PSMA (68Ga) PET/CT as a tool to guide treatment choice in patients with high risk prostate cancer.
IRAS ID
233672
Contact name
Hing Leung
Contact email
Sponsor organisation
Public Health Scotland (PHS)
ISRCTN Number
ISRCTN56584901
Clinicaltrials.gov Identifier
pending, ISRCTN
Duration of Study in the UK
0 years, 9 months, 30 days
Research summary
Research Summary
We want to test the effectiveness of a new radioactive tracer called 68Ga-THP-PSMA.This radioactive tracer/agent produces a minute amount of radiation (a type of radiation similar to an x-ray) and is increasingly used in clinical scans. The signal from the tracer is detected using the very sensitive PET/CT scanning method. The ability to combine signals from PET scan and that of the CT scan provide us with important information about the location of the tracer activity and information such as the location of the lymph nodes in your pelvis (near the prostate). It is hoped that the PSMA PET/CT scan will identify whether or not the cancer has spread to the lymph nodes. This will mean that for future patients, where there is no evidence of spread of cancer to the lymph nodes, can have less extensive surgery. They will not have to have their pelvic lymph nodes removed at the time of surgery (also called a prostatectomy). This would reduce costs and operating time in patients at low risk of the cancer spreading to the lymph nodes. In addition it would minimise unnecessary surgery related morbidities in these low risk patients.
The PSMA imaging study is a feasibility study of 60 patients with high risk prostate cancer. Patients will be recruited from 4 sites in the UK: Addenbrooke’s Hospital, Cambridge; Christie Hospital, Manchester; Queen Elizabeth University Hospital, Glasgow and University College London Hospital, London.
Eligible patients who have given written informed consent will undergo a PSMA PET/CT scan after standard of care imaging. The doctors, patients and the clinical team treating the patients will not know the results of the PSMA PET/CT scan. This is to ensure that the surgery will be carried out as per current hospital practice using results from standard imaging.Summary of Results
The PANORAMA study wanted to study the levels of a molecule called PSMA (Prostate Specific Membrane Antigen) in the prostate cancer within the prostate gland and in the lymph nodes that might be affected by cancer. A molecule is a group of two or more atoms held together by chemical bonds. An antigen is a toxin which induces an immune response. Most prostate cancers grow very slowly but, in some men, prostate cancer can grow more quickly. In some cases, prostate cancer may spread to other parts of the body.
A common place for prostate cancer to spread to is the lymph nodes (sometimes called lymph glands). Lymph nodes are part of the lymphatic system. They are found throughout the body and some of the lymph nodes are in the pelvic area, near the prostate. The process of determining how much cancer is in the body and where it is located is known as staging. At present it is very difficult to find out if the prostate cancer has spread to the lymph glands in the pelvis. It is important to know this as it will help doctors to plan treatment better.The purpose of the study was to discover whether the PSMA molecule linked to a radioactive tracer (68Ga-HBED-PSMA-11) was effective at finding cancer cells in lymph glands. The study wanted to determine whether the absence of PSMA in the lymph glands on the scan reliably indicated the absence of cancer in the tissue. This would help determine whether or not 68Ga-HBED-PSMA-11 PET/CT was able to show if the cancer had spread to the lymph nodes, and avoid unnecessary lymph node removal – a more invasive procedure.
The Sponsor of the trial was Public Health Scotland (PHS) which is based in the United Kingdom. This Imaging study was coordinated by the Scottish Clinical Trials Research Unit, in Edinburgh, which is a Public Health Scotland organisation that receives funding from the Scottish government. All study procedures were provided by the NHS.
Cancer Research UK provided funds to cover the costs of running the study.
Five patients took part in the study from two hospitals in the UK, Addenbrookes Hospital, Cambridge and University College Hospital London. The trial stopped recruiting patients on 21st January 2022. The trial did not recruit enough patients to draw any conclusions from the study.
REC name
West of Scotland REC 1
REC reference
17/WS/0201
Date of REC Opinion
6 Nov 2017
REC opinion
Further Information Favourable Opinion