Evaluation of the Concordance Between Pre-therapy Dosimetry Performed From 68Ga-PSMA-11 Dynamic PET and Post-treatment Dosimetry of 177Lu-PSMA-617 Vectorized Internal Radiotherapy in Patients With Metastatic Prostate Cancer Resistant to Hormonal Castration. (GaLuPro)

November 13, 2023 updated by: Centre Georges Francois Leclerc

Patients undergo three diagnostic PET scans: 18F-FDG PET scan / 18F-Choline PET scan and 68Ga-PSMA PET scan. Following the diagnostic PET scans, and if patients' eligibility for 177Lu-PSMA-617 IVR treatment is confirmed, SPECT acquisitions will be performed during the first treatment course at 5h, 24h, 4 days and 8 days for dosimetric control.

The patient will then return to the nuclear medicine department to undergo SPECT/CT (3 FOV) acquisitions using the same methods as those presented above and recommended in the standard management at : D+24h post-injection, D+4d post-injection and D+8d post-injection No further research-specific acts or procedures will be performed at the end of the first treatment course.

Continuity of treatment will be carried out in accordance with standard management and treatment requirements and modalities, as will clinical, biological and radiological follow-up.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Internal vectored radiotherapy (IVRT) for mCPRCs is emerging as a new treatment line of choice. Radiolabeled molecules with a high affinity for PSMA have emerged as promising theranostic radiopharmaceuticals for the management of mCPRCs.

The 177Lu-PSMA-617 had substantial anti-tumor effects, including a beneficial effect on survival in cases of mCRPC. With regard to the choice of diagnostic radiopharmaceutical, which must be homologous to the therapeutic agent, 68Ga-PSMA-11 PET/CT showed significantly higher sensitivity and specificity than traditional radiological imaging for detecting lymph node or bone metastases in prostate cancer. The evaluation of 177Lu-PSMA-617 as a new radiopharmaceutical also requires a dosimetry step, which is essential for studying the "injected activity - therapeutic response - adverse effects/toxicity" relationship.

The aim of this study is to carry out a dynamic 68Ga-PSMA-11 PET acquisition in order to evaluate pre-therapy absorbed doses and to compare these with post-therapy dosimetry carried out during the first course of 177Lu-PSMA-617 treatment using SPECT acquisitions.

This research is part of standard management and will not modify the activities of radiopharmaceuticals administered during diagnostic PET examinations with 18F-FDG, 18F-Choline and 68Ga-PSMA-11 or during treatment with 177Lu-PSMA-617.

Patients undergo three diagnostic PET scans: 18F-FDG PET scan / 18F-Choline PET scan and 68Ga-PSMA PET scan. Following the diagnostic PET scans, and if patients' eligibility for 177Lu-PSMA-617 IVR treatment is confirmed, SPECT acquisitions will be performed during the first treatment course at 5h, 24h, 4 days and 8 days for dosimetric control.

The patient will then return to the nuclear medicine department to undergo SPECT/CT (3 FOV) acquisitions using the same methods as those presented above and recommended in the standard management at : D+24h post-injection, D+4d post-injection and D+8d post-injection No further research-specific acts or procedures will be performed at the end of the first treatment course.

Continuity of treatment will be carried out in accordance with standard management and treatment requirements and modalities, as will clinical, biological and radiological follow-up.

Study Type

Interventional

Enrollment (Estimated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Clément DROUET, Dr
  • Phone Number: +33 03.80.73.75.00
  • Email: CLDrouet@cgfl.fr

Study Contact Backup

  • Name: Néréa PAYAN, Dr
  • Phone Number: +33 03.80.73.75.00
  • Email: NPayan@cgfl.fr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients over 18 with histologically proven metastatic prostate cancer treated with taxane chemotherapy plus at least one second-generation hormone therapy and resistant to hormonal castration (eligibility criterion for 177Lu-PSMA IVR treatment).
  • Patient referred to CGFL for standard disease management with indication for 18F-FDG PET, 18F-Choline PET and 68Ga-PSMA-11 PET to validate patient's eligibility for 177Lu-PSMA-617 IVR treatment.
  • ECOG ≤ 2
  • Life expectancy ≥ 6 months
  • No unacceptable medical or radiological risk for isolation in a nuclear medicine therapy unit.
  • Patient informed about the study, able to understand the study constraints and sign the consent form.
  • Patient affiliated to the social security system or equivalent

Exclusion Criteria:

  • Inability of the patient to maintain a lying position, without moving, for more than 1 hour (1 hour 20 minutes of acquisition for the dynamic PET acquisition specific to the GaLuPro study).
  • Allergy to 68Ga-PSMA-11 or 177Lu-PSMA-617
  • Contraindications to receiving 177Lu-PSMA IVR treatment and/or performing the imaging tests required by the protocol (patient with pacemaker or defibrillator).
  • Urinary tract obstruction or hydronephrosis. Patients with a diagnosis or high risk of urinary retention and/or fitted with a urinary catheter and/or with incontinence making urine collection impossible or PET examinations impossible.
  • Patient refusal to participate in study
  • Impossibility for the patient to undergo medical monitoring and compliance with treatment and trial procedures for geographical, social or psychological reasons.
  • Persons deprived of their liberty or under guardianship (including curatorship)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RIV treatment with 177Lu-PSMA-617.
Radiation: 177Lu-PSMA-617 PET scan
Patients then begin their first course of treatment an average of 2 months after the 68Ga-PSMA-11 PET scan, with IVR usually divided into a total of 6 courses. During the first course of treatment, patients undergo an initial SPECT scan 5h (±1h) post-injection, and return to the nuclear medicine department for three further SPECT scans, at 24h, 4 days and 8 days post-injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study the correlation between pre- and post-treatment estimates of absorbed doses to organs at risk
Time Frame: During 12 months
Pre-treatment absorbed dose estimates will be determined during 68Ga-PSMA-11 PET acquisitions. Post-treatment absorbed dose estimates will be determined using 177Lu-PSMA-617 SPECT acquisitions.
During 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Georges Francois Leclerc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 31, 2024

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

November 13, 2023

First Submitted That Met QC Criteria

November 13, 2023

First Posted (Estimated)

November 17, 2023

Study Record Updates

Last Update Posted (Estimated)

November 17, 2023

Last Update Submitted That Met QC Criteria

November 13, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-A02235-40

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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