NCT07587814

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
33mo left

Started Sep 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2026

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 14, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

May 14, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

April 20, 2026

Last Update Submit

May 11, 2026

Conditions

CarcinomaCastration Resistant Prostatic Neoplasms

Keywords

Lutetium-177PSMABody compositionDosimetryRadioligand therapyProstate cancer

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (2)

  • 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

Study Arms (1)

COCORIVO

EXPERIMENTAL

Patients with mCRPC treated with 177Lu-PSMA-617 undergoing additional SPECT/CT acquisitions and body composition analysis

Radiation: 177Lu-PSMA-617 + SPECT/CT dosimetry

Interventions

177Lu-PSMA-617 + SPECT/CT dosimetryRADIATION

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.

COCORIVO

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patient unable to understand the study or comply with study constraints (language barrier, psychological, geographic...)
  • Patient under legal protection (tutelle, curatelle, sauvegarde de justice)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Henri Becquerel

Rouen, Normanie, 76038, France

Location

MeSH Terms

Conditions

CarcinomaProstatic Neoplasms, Castration-ResistantProstatic Neoplasms

Interventions

Pluvicto

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Central Study Contacts

Pierre Decazes, MD, PhD

CONTACT

+33 2 76 67 30 59pierre.decazes@chb.unicancer.fr

Doriane Richard, PhD

CONTACT

+33 2 32 08 29 85doriane.richard@chb.unicancer.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2026

First Posted

May 14, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

June 1, 2029

Last Updated

May 14, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)