IP10 - AVIDITY
Research type
Research Study
Full title
A multicentre randomised controlled trial to assess the clinical effectiveness and cost-effectiveness of PSMA PET/CT imaging to stage newly diagnosed high risk prostate cancer compared to standard of care CT and bone scan imaging
IRAS ID
364205
Contact name
Hashim Uddin Ahmed
Contact email
Sponsor organisation
Imperial College London
Clinicaltrials.gov Identifier
25/LO/0645, REC Reference No:
Duration of Study in the UK
7 years, 0 months, 1 days
Research summary
In this study, we want to see if we should be using an imaging test called PSMA PET/CT in patients with newly diagnosed high-risk prostate cancer. This new single scan uses a special tracer to identify prostate cancer cells anywhere in the body. PSMA PET/CT is safe and can detect cancer deposits (metastasis) more accurately than a CT and bone-scan. However, we do not know whether finding distant areas of cancer early on the single scan (PSMA PET/CT) will actually lead to better cancer outcomes. This is because patients with cancer that has spread have limited options for treatment and some treatments such as surgery or radiotherapy are not given. PSMA PET/CT may also identify areas of cancer deposits that are not cancer and these “false positives” can prevent patients being offered curative surgery or radiotherapy treatments for their cancer.
PSMA PET/CT is not approved for standard care in the NHS.
We want to carry out an RCT in which patients with high risk prostate cancer will be allocated to one of two groups. Group 1 involves treatment being directed by a CT and bone scan according to current cancer guidelines and local multidisciplinary team care. Group 2 will have their treatment guided by a PSMA PET/CT scan. They will have standard care treatment and in addition will have treatment to involved lymph nodes and/or areas of distant cancer that the PSMA PET/CT has identified. Both groups will be followed up carefully by their clinical team. In order to measure whether there is a cancer control benefit, we will scan them with a bone scan and CT at 2 years and 4 years. This will ensure that we can detect or rule out cancer progression on all patients and will give a clearer answer to inform practice and guidelines in future.
REC name
Wales REC 5
REC reference
25/WA/0367
Date of REC Opinion
19 Dec 2025
REC opinion
Favourable Opinion