Evaluation of Lutetium (177Lu) rhPSMA-10.1 injection in men with mCRPC
Research type
Research Study
Full title
An open-label, multicentre, integrated Phase 1 & 2 study to evaluate the safety, tolerability, radiation dosimetry and anti-tumour activity of Lutetium (177Lu) rhPSMA-10.1 injection in men with metastatic castrate-resistant prostate cancer
IRAS ID
1011550
Contact name
Felicity Lyon-Staniewski
Contact email
Sponsor organisation
Blue Earth Therapeutics Limited
Clinicaltrials.gov Identifier
Research summary
This study is being run to understand if Lutetium (177Lu) rhPSMA-10.1 Injection can help treat metastatic castrate-resistant prostate cancer (mCRPC). Prostate cancer cells usually have a protein called prostate-specific membrane antigen (PSMA) on their surface. Lutetium (177Lu) rhPSMA-10.1 Injection is a test medication that is designed to attach to PSMA and deliver radiation directly to the cancer cells to destroy or shrink them. Eligible participants will be male adults aged 18 years or older with PSMA positive mCRPC that has stopped responding to previous treatment with medicines that block the male hormones and who have not yet received chemotherapy.
Eligible participants will be randomly placed in 1 of 3 possible groups. These are Groups 2A, 2B, and 2C. Groups 2A and 2B will be opened first. A group of doctors and scientists will decide whether to open Group 2C based on early safety results after some participants have been dosed in Groups 2A and 2B. All participants will receive Lutetium (177Lu) rhPSMA-10.1 Injection for about 36 or 42 weeks. The participants and researchers will know the treatment that is being given in the study. Participants will be in the study for about 10 to 12 months. The participants will have regular checkups at the study site. They will have procedures such as blood and urine tests, electrocardiogram (ECG), and imaging scans such as positron emission tomography (PET), computed tomography (CT) or magnetic resonance imaging (MRI), and bone scans. At the end of treatment, researchers will monitor the participants’ health every 12 weeks. If the imaging scans show that the prostate cancer has spread, the researchers will then contact the participants’ doctors every 6 months to ask about the participants’ health and monitor for any long-term side effects that they may have. This global trial is planned to run in 7 hospitals in the UK.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
25/NW/0112
Date of REC Opinion
21 May 2025
REC opinion
Further Information Favourable Opinion