CAAA617H12101: A Phase I, RLT study in Metastatic Neuroendocrine Prostate Cancer
Research type
Research Study
Full title
A Phase I, open-label, multi-center exploratory safety and efficacy study with PSMA, SSTR2 and GRPR targeted radioligand therapy in metastatic neuroendocrine prostate cancer
IRAS ID
1007989
Contact name
Daniel Monney
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2023-505655-43
Research summary
Neuroendocrine prostate cancer (NEPC) is a subtype of prostate cancer that most commonly arises in later stages of prostate cancer (though some patients may have it at diagnosis). In some cases, the disease may spread beyond the prostate gland and affect different parts of the body (referred to as metastases, or metastatic prostate cancer); in these cases, treatment will be required. This study is looking at patients who have been either diagnosed with metastatic NEPC. This is an advanced form of prostate cancer. The purpose of the treatment offered in this study is to identify which of the three types of cancer promoting protein is present on cell surfaces and so being able to target these specific cancer cells with the right radioactive treatment. The administration of a substance that has a large amount of radioactivity (RLT) binds specifically to a target, in this case, to cancer cells with specific proteins (PSMA, SSTR2, or GRPR), and delivers radiation to kill specifically those cancer cells. All RLT in this study will be given in de novo or treatment emergent patients with metastatic neuroendocrine prostate cancer (mNEPC) and contains Lutetium 177 as the radioactive treatment. Positron Emission Tomography / Computed Tomography (PET/CT) scans will be performed using imaging agents (3) that detect PSMA-positive, SSTR2-positive, or GRPR-positive prostate cancer cells. PET/CT scan will be used to identify participants who are eligible for each RLT treatment arm. Based on the results of the RLI, participants will be assigned to receive one of the three RLTs:
• [177Lu]Lu-PSMA-617
• [177Lu]Lu-DOTA-TATE
• [177Lu]Lu-NeoB
During the study treatment period, participants will undergo a number of assessments. Conventional imaging (MRI, SPECT PET/CT) will be carried out to evaluate subsequent changes in efficacy following targeted RLT. Planned duration of treatment is up to 36 weeks with treatment given every 6 weeks.REC name
London - Westminster Research Ethics Committee
REC reference
24/LO/0229
Date of REC Opinion
3 Jun 2024
REC opinion
Further Information Favourable Opinion