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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A01010-49 | Other Identifier | Ministry of Health |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COCORIVO | Experimental | Patients with mCRPC treated with 177Lu-PSMA-617 undergoing additional SPECT/CT acquisitions and body composition analysis |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 177Lu-PSMA-617 + SPECT/CT dosimetry | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After cycle 1 of 177Lu-PSMA treatment (approximately week 1) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pierre Decazes, MD, PhD | Contact | +33 2 76 67 30 59 | pierre.decazes@chb.unicancer.fr | |
| Doriane Richard, PhD | Contact | +33 2 32 08 29 85 | doriane.richard@chb.unicancer.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Henri Becquerel | Rouen | Normanie | 76038 | France |
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| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D064129 | Prostatic Neoplasms, Castration-Resistant |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D005834 | Genital Neoplasms, Male |
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| ID | Term |
|---|---|
| C000610110 | Pluvicto |
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|
Comparison of dosimetry |
| 196 hours after the injection of the first cycle of 177LuPSMA |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |