NCT03927521

Brief Summary

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. 1.To identify at an early stage the metastatic patients and to allow a more adapted therapeutic management.
  2. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Jun 2020

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 25, 2019

Completed
1.2 years until next milestone

Study Start

First participant enrolled

June 23, 2020

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2024

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

3.7 years

First QC Date

April 17, 2019

Last Update Submit

May 7, 2024

Conditions

Prostate Cancer

Keywords

Prostate cancerPost-RadiotherapyFocal HIFUPSMAPET-MRILocal recurrence

Outcome Measures

Primary Outcomes (1)

  • Feasibility to use the PET-MRI/68Ga-PSMA imaging for Focal-HIFU guidance

    The feasibility to use the PET-MRI/68Ga-PSMA imaging for Focal-HIFU guidance will be evaluated by the possibility or not to use the target tumor contouring with the TEP-IRM au \[68Ga\]PSMA. This possibility will be determine for each patient with a systematic reviewing of TEP-IRM/\[68Ga\]PSMA and the target tumor contouring by 2 experts: a nuclear medicine specialist for TEP/\[68Ga\] PSMA and a radiologist, prostate MRI specialized.

    At the time of the HIFU-focal treatment

Secondary Outcomes (16)

  • Interest of hybrid PET-MRI/[68Ga]PSMA imaging compared to PET-Choline for the metastasis detection during the initial assessment of first recurrence after radiotherapy.

    Screening period.

  • Interest of hybrid PET-MRI/[68Ga]PSMA imaging compared to standard multiparametric MRI performed at the initial assessment AND 6 month after Focal-HIFU.

    6 months after focal HIFU therapy

  • Biological recurrence

    3 months and 6 months after focal HIFU therapy

  • Local control of tumor recurrence 6 months after Focal-HIFU guided by PET-MRI/[68Ga]PSMA imaging.

    6 months after focal HIFU therapy

  • Proportion of positives prostate biopsies

    3 months and 6 months after focal HIFU therapy

  • +11 more secondary outcomes

Study Arms (1)

Focal HIFU guided by PET-MRI/68Ga-PSMA imaging

EXPERIMENTAL

Patient with local/focal prostate cancer recurrence after radiotherapy and no distant metastasis (negative PET-Choline imaging confirmed by PET-MRI/68Ga-PSMA) will be treated by Focal-HIFU

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

Interventions

Focal HIFU using PET-MRI/68Ga-PSMA imaging guidancePROCEDURE

Focal HIFU treatment will be conducted with the Focal One® device using the PET-MRI/68Ga-PSMA imaging. The treatment area will be defined using PET-MRI/68Ga-PSMA imaging data and 3D biopsies.

Focal HIFU guided by PET-MRI/68Ga-PSMA imaging

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 50 years with a life expectancy of more than 5 years. Patients between the ages of 75 and 80 will need to have a G8 score \> 14.
  • Biological recurrence after prostate radiotherapy confirmed with de Phoenix criteria (nadir + 2 ng/mL).
  • No prior or present evidence of lymph node metastasis, soft tissue metastasis or bone metastasis, assessed by the current radiographic exam (PET-Choline) AND the PET-MRI/68Ga-PSMA before Focal-HIFU.
  • Local prostate cancer recurrence confirmed by:
  • A multiparametric MRI showing a single tumor in the prostate gland at most 3 contiguous sextants confirmed by biopsies (Index tumor). Patients with multiple suspected MRI foci may be included if only one of these foci is confirmed by biopsies.
  • Index tumor confirmed by the PET-MRI/68Ga-PSMA.
  • PSA ≤ 10ng/ml.
  • Patient having been clearly informed of the study and having accepted, with sufficient reflection time, to participate by signing the informed consent form of the study.
  • Patient affiliated with health insurance or beneficiary of an equivalent plan.

You may not qualify if:

  • Contraindications to Focal-HIFU treatment.
  • Patient with a medical contraindication to Sonovue® injection.
  • Patient with a medical contraindication to MRI.
  • History of uncontrolled cancer and / or treated for less than 5 years (with the exception of basal cell skin cancer).
  • History of sclerosis of the bladder neck or urethral stenosis.
  • Patient at risk of bleeding according to medical advice. Patient with anticoagulants therapy must receive a treatment relay.
  • Patients with unstable neurological pathology.
  • Patient who has been treated for a therapeutic trial within 30 days of enrollment or who wishes to participate in an ongoing study that may interfere with this study.
  • Legal person protected by law.
  • Patient not able to understand the objectives of the study or refusing to comply with postoperative instructions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'Urologie et Chirurgie de la Transplantation - Hôpital Edouard Herriot - Hospices Civils de Lyon

Lyon, 69437, France

Location

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

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

Study Record Dates

First Submitted

April 17, 2019

First Posted

April 25, 2019

Study Start

June 23, 2020

Primary Completion

March 11, 2024

Study Completion

March 11, 2024

Last Updated

May 8, 2024

Record last verified: 2024-05

Locations

FR(1)