PROter/LU-PSMA - A206T-G01-001
Research type
Research Study
Full title
A phase 1/2 open-label, multi-center, dose-escalation study of safety, tolerability, pharmacokinetics, dosimetry and response to repeat dosing of 177Lu-PSMA-R2 radio-ligand therapy in patients with prostate specific membrane antigen (PSMA) positive (68Ga-PSMA-R2) progressive metastatic castration-resistant prostate cancer, following previous systemic treatment
IRAS ID
247990
Contact name
Chris Parker
Contact email
Sponsor organisation
Advanced Accelerator Applications International SA
Eudract number
2017-004034-29
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
135431, IND Number
Duration of Study in the UK
7 years, 6 months, 18 days
Research summary
Summary of Research
This is a phase 1/2, open-label, multi-centre, dose-escalation, non-randomised study of Lu-PSMA-R2 in patients with adenocarcinoma of the prostate (prostate cancer)and radiographic computed tomography (CT)/magnetic resonance imaging (MRI) or bone scan evidence of metastatic (advanced)disease. Potential male participants must be aged 18 or over and have a diagnosis of adenocarcinoma of the prostate. They must have either been unable to receive chemotherapy, or had no more than one line of chemotherapy prior to enrolment in the study. The study has been designed to look at the safety and tolerability of the study drug, Lu-PSMA-R2, when given in increasing doses to different groups of participants. All participants will receive three cycles of Lu-PSMA-R2 as an infusion, six weeks apart, and will undergo Ga-PSMA-R2 positive emission tomography (PET) imaging as part of the study to identify lesions that may be responsive to treatment. This means that each participant will receive up to six injections of Ga-PSMA-R2 which is an imaging agent that helps identify tumours. Participants will also undergo a range of investigations including blood and urine tests, electrocardiogram (ECG), imaging assessments and physical examination to record the participant's response to the study drug, and maintain safety. Participants will also be asked to complete a number of health-related questionnaires throughout the study. The study will last approximately 18-33 months with up to five years of long-term follow-up. The study is being run in a number of NHS hospitals across the UK, in addition to Spain and the USA.Summary of Results
Lay summary of study results: Pending.REC name
East of England - Essex Research Ethics Committee
REC reference
18/EE/0277
Date of REC Opinion
8 Nov 2018
REC opinion
Further Information Favourable Opinion