An interventional study of 177Lu-PSMA-617 + SPECT/CT dosimetry in Carcinoma and Castration Resistant Prostatic Neoplasms, sponsored by Centre Henri Becquerel. Not yet recruiting at 1 site in France. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by Centre Henri Becquerel · Not applicable, Interventional, and Basic science
COCORIVO is an interventional study evaluating the impact of body composition on dosimetry of 177Lu-PSMA radioligand therapy in patients with metastatic castration-resistant prostate cancer (mCRPC). Body composition (muscle, lean, visceral fat, subcutaneous fat and total fat masses) will be automatically quantified from whole-body CT images acquired at 72-96h after 177Lu-PSMA injection using the Anthropometer3DNet software. Dosimetry will be evaluated for tumors and organs at risk (salivary glands, bone marrow, kidneys). The study also evaluates the impact of body composition on SUV quantification, the feasibility of single-timepoint dosimetry, and the evolution of body composition during treatment.
Prostate-specific membrane antigen (PSMA) is highly expressed in metastatic castration-resistant prostate cancer. 177Lu-PSMA-617 is a radioligand therapy delivering beta-particle radiation to PSMA-expressing cells. The VISION trial demonstrated significant improvement in progression-free and overall survival compared to standard of care.
Hypotheses: patients with higher fat mass may have better treatment response due to higher tumor dose; discordance between BMI-based and CT-based body composition measurements; SUV quantification in PET/CT and SPECT/CT depends on patient morphology; dosimetry of organs at risk depends on morphology; body composition changes during treatment; PSA kinetics are modified by dosimetry.
Study design: patients scheduled for 177Lu-PSMA treatment (4 or 6 cycles, 7400 MBq IV every 6 weeks) are enrolled. After cycle 1, SPECT/CT is performed at 72-96H (all patients) and additionally at 4-24H and 168-196H (40 patients for multipoint dosimetry). Body composition is extracted from the non-injected CT component of SPECT/CT using Anthropometer3DNet. Nutritional assessment (MNA questionnaire, blood tests including albumin, transthyretin, CRP, PSA) is performed at baseline (C1) and end of treatment (C4 or C6).
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 100 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Centre Henri Becquerel is the lead sponsor of 57 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
Patients with mCRPC treated with 177Lu-PSMA-617 undergoing additional SPECT/CT acquisitions and body composition analysis
Radiation: 177Lu-PSMA-617 + SPECT/CT dosimetry
177Lu-PSMA-617 7400 MBq IV, 4 to 6 cycles every 6 weeks (standard of care). Additional interventions: whole-body SPECT/CT at 4-24H and/or 168-196H post-injection (research acquisitions) for dosimetry. Body composition analysis from SPECT/CT scanner using Anthropometer3DNet. MNA questionnaire and nutritional blood tests at baseline and end of treatment.
Tumor and organ-at-risk dosimetry as a function of body composition
Dosimetry (Gy) of all tumors and organs at risk (salivary glands, bone marrow, kidneys) evaluated by SPECT/CT at 72-96H post-injection. Patients classified into two categories based on median body composition of the study population.
Time frame: After cycle 1 of 177Lu-PSMA treatment (approximately week 1)
Comparison of SUV vs SUL in 68Ga-PSMA PET/CT and 177Lu-PSMA SPECT/CT
Comparison of SUV (normalized by total body mass) and SUL (normalized by lean body mass) of lesions and organs at risk. Difference \<20% considered equivalent.
Time frame: Baseline and after cycle 1 (approximately week 1)
Evaluate the differences between a single-point dosimetric approach based on population pharmacokinetics and a multi-point approach
Comparison of dosimetry
Time frame: 196 hours after the injection of the first cycle of 177LuPSMA
Plan to share: No
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Centre Henri Becquerel