NCT03927521: PSMA

Feasibility Study on the Use of PET-MRI / 68Ga-PSMA Imaging for HIFU-focal Treatment in the Event of Recurrent Prostate Cancer After Radiotherapy - PSMA Study

Completed NA Last updated 8 May 2024

What this trial tests

NA trial testing Focal HIFU using PET-MRI/68Ga-PSMA imaging guidance in Prostate Cancer in 11 participants. Completed in 11 March 2024.

Timeline

23 June 2020

Primary endpoint
11 March 2024

11 March 2024

Quick facts

Lead sponsor	Hospices Civils de Lyon
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	11
Start date	23 June 2020
Primary completion	11 March 2024
Estimated completion	11 March 2024
Sites	1 location across France

Drugs / interventions tested

• Focal HIFU using PET-MRI/68Ga-PSMA imaging guidance

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

50 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A significant proportion of patients with localized prostate cancer, and treated for curative intent by radiotherapy, have a local recurrence. Among these patients with local recurrence, few receive curative remedial treatment but most of them are treated with palliative hormonal therapy without any chance of long-term recovery.

The use of Focused Ultrasound (HIFU) in focal treatment (only on recurrence) is an effective and not very morbid option, especially compared to surgery. The quality of this treatment is conditioned by both an early diagnosis of recurrence, a precise localization of recurrence in the prostate and a rigorous extension assessment for the detection of occult metastases.

Innovations in medical imaging have led to the development of a new generation of "hybrid" machines that combine PET (Positron Emission Tomodensitometry) and MRI (Magnetic Resonance Imaging) technology. Associated with the use of 68Gallium-labeled PSMA (Prostate-Specific Membrane Antigen), a new tracer specific for prostate cancer, the investigators believe that this PET-MRI imaging technique can:

1. To identify at an early stage the metastatic patients and to allow a more adapted therapeutic management.
2. A better evaluation of the limits of local recurrence and therefore a more precise definition than with MRI alone of the tumor zone to be destroyed.

Finally, the investigators believe that the PET-MRI / 68Ga-PSMA exam, used for the selection of patients eligible for focal HIFU treatment and used for the treatment itself, should allow obtaining an optimal control of the cancer recurrence with the least possible side effects.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. High-Intensity Focused Ultrasound: A Review of Mechanisms and Clinical Applications.
   Bachu VS, Kedda J, Suk I, Green JJ, et al · · 2021 · cited 166× · PMID 34374945 · DOI 10.1007/s10439-021-02833-9
2. Immunomodulation and targeted drug delivery with high intensity focused ultrasound (HIFU): Principles and mechanisms.
   Ashar H, Ranjan A. · · 2023 · cited 41× · PMID 36965581 · DOI 10.1016/j.pharmthera.2023.108393