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NCT Number: NCT07587814

Impact of Body Composition on Dosimetry of 177Lu-PSMA Radioligand Therapy

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.

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Key information

Conditions

Carcinoma Castration Resistant Prostatic Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Prostatic Diseases Prostatic Neoplasms Prostatic Neoplasms, Castration-Resistant Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Tumor and organ-at-risk dosimetry as a function of body composition

    Time frame: 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 outcomes

  1. 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)

    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.

  2. 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

    Comparison of dosimetry

Study contacts

Contact information is provided by the study sponsor or research team.

Doriane Richard, PhD

CONTACT

[email protected]

+33 2 32 08 29 85

Pierre Decazes, MD, PhD

CONTACT

[email protected]

+33 2 76 67 30 59

Sponsors and collaborators

Lead sponsor

Centre Henri Becquerel

Other

Registry information

Official study title

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

Acronym: COCORIVO

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
May 14, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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