CAAA617A12101: Phase 1 Extended Treatment Dosimetry Study
Research type
Research Study
Full title
A Phase I, open-label, multi-center study of radiation dosimetry, safety, and tolerability of extended lutetium (177Lu) vipivotide tetraxetan treatment in chemo-naïve adults with metastatic castration-resistant prostate cancer: RADIOpharmaceutical DOSimetry Evaluation (RADIODOSE) study
IRAS ID
1009375
Contact name
Léa Dusuel
Contact email
Sponsor organisation
Novartis Pharma AG
ISRCTN Number
ISRCTN40970912
Research summary
This study aims to look at the radiation dose, safety, and tolerability of the study treatment, [177Lu]Lu-PSMA-617 (hereafter referred to as AAA617), in patients with PSMA-positive Metastatic Castration-Resistant Prostate Cancer (mCRPC). This is a subtype of prostate cancer where the disease has spread beyond the prostate gland and affects different parts of the body (referred to as metastases, or metastatic prostate cancer). PSMA is a protein which is highly expressed on prostate cancer cells but has low expression in normal tissues, so is a key indicator of prostate cancer and is targeted in diagnostics. Participants will undergo Positron Emission Tomography / Computed Tomography (PET/CT) imaging using the diagnostic agent 68Ga-PSMA-11, a radioactive drug which binds to PSMA, which will allow comparison of levels of PSMA. Based on the PET/CT imaging, participants will be grouped into cohorts with normal, moderate, or severe renal (kidney) impairment. All participants in the 3 cohorts will receive AAA617 once every 6 weeks, up to 6 cycles for normal and moderate renal impairment, and 3-6 cycles in severe renal impairment. AAA617 is a radioligand therapy (RLT) drug which binds to the PSMA expressed on prostate cancer cells, releases small levels of radiation, and aims to reduce the cancerous cells. At the end of cycle 6, PET/CT scans will be repeated using 68Ga-PSMA-11 to evaluate changes in PSMA levels following RLT.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
24/SC/0225
Date of REC Opinion
14 Aug 2024
REC opinion
Further Information Favourable Opinion