Impact of Body Composition on Dosimetry of 177Lu-PSMA Radioligand Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 177Lu-PSMA-617 + SPECT/CT dosimetry.
- Who it may be relevant to
- Registry conditions: Carcinoma, Castration Resistant Prostatic Neoplasms. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact de la Composition Corporelle Sur la dosimétrie de la radiothérapie Interne vectorisée au 177Lu-PSMA
Overview
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.
Detailed description
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).
Interventions
- 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.
Primary outcome measures
- Tumor and organ-at-risk dosimetry as a function of body composition [Time frame: After cycle 1 of 177Lu-PSMA treatment (approximately week 1)]
Secondary outcome measures (2)
- Comparison of SUV vs SUL in 68Ga-PSMA PET/CT and 177Lu-PSMA SPECT/CT [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 [Time frame: 196 hours after the injection of the first cycle of 177LuPSMA]
Eligibility criteria
Inclusion criteria
- Signed informed consent
- Male, age >= 18 years
- Histologically confirmed prostatic adenocarcinoma with multidisciplinary decision for 177Lu-PSMA treatment
- PSMA expression in tumor lesions confirmed by 68Ga-PSMA PET/CT
- Affiliated to or beneficiary of a social security scheme
Exclusion criteria
- Patient unable to understand the study or comply with study constraints (language barrier, psychological, geographic...)
- Patient under legal protection (tutelle, curatelle, sauvegarde de justice)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
France · 1 center
- Centre Henri Becquerel — Rouen
Identifiers
NCT: NCT07587814 · CHB 25.05 · 2025-A01010-49