Impact de la Composition Corporelle Sur la dosimétrie de la radiothérapie Interne vectorisée au 177Lu-PSMA

Official 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.

Eligibility Requirements

• Minimum Age: 18 Years
• Sex: MALE

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 100 participants

Study Arms

• COCORIVO (EXPERIMENTAL)
  Patients with mCRPC treated with 177Lu-PSMA-617 undergoing additional SPECT/CT acquisitions and body composition analysis

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 Outcomes

• Tumor and organ-at-risk dosimetry as a function of body composition (After cycle 1 of 177Lu-PSMA treatment (approximately week 1))

Secondary Outcomes

• Comparison of SUV vs SUL in 68Ga-PSMA PET/CT and 177Lu-PSMA SPECT/CT (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 (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)

Trial Locations

• Centre Henri Becquerel, Rouen, Normanie, France

Contact Information

• Pierre Decazes, MD, PhD — CONTACT
  Phone: +33 2 76 67 30 59
  Email: pierre.decazes@chb.unicancer.fr
• Doriane Richard, PhD — CONTACT
  Phone: +33 2 32 08 29 85
  Email: doriane.richard@chb.unicancer.fr

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