Carcinoma, Castration Resistant Prostatic Neoplasms
Conditions
Keywords
Lutetium-177, PSMA, Body composition, Dosimetry, Radioligand therapy, Prostate cancer
Brief summary
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
RADIATION177Lu-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.
Sponsors
Centre Henri Becquerel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor and organ-at-risk dosimetry as a function of body composition | After cycle 1 of 177Lu-PSMA treatment (approximately week 1) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of SUV vs SUL in 68Ga-PSMA PET/CT and 177Lu-PSMA SPECT/CT | Baseline and after cycle 1 (approximately week 1) | 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. |
| Evaluate the differences between a single-point dosimetric approach based on population pharmacokinetics and a multi-point approach | 196 hours after the injection of the first cycle of 177LuPSMA | Comparison of dosimetry |
Countries
France
Contacts
CONTACTPierre Decazes, MD, PhD
CONTACTDoriane Richard, PhD
Outcome results
None listed