EvaluatioN of HIFU Hemiablation and Short Term AndrogeN Deprivation Therapy Combination to Enhance Prostate Cancer Control.

NCT03845751 | Unknown Phase 2

• 1 other identifier: URO-01-2019
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The current study aims to examine the hypothesis that combining the focal effects of HIFU with the systemic effects of androgen deprivation therapy might eradicate the prostatic cancer cells by targeting the 'visible' index focus (by HIFU) and the tumour surrounding microenvironment which may contain 'invisible' foci and aberrant PCa related signalling (by androgen deprivation therapy) to enhance oncological outcomes of HIFU hemi-ablation in men with localized PCa, and consequently reducing treatment failures.

Conditions

Prostate Cancer; Androgen Deprivation Therapy

Keywords

HIFU; hemi ablation; focal therapy

Outcome Measures

Primary Outcomes (1)

• Oncological outcome

  Number of treatment failures determined after prostatic biopsy and defined as: * Any Gleason pattern ≥4. * Any Gleason score ≥7.

  12 months after the HIFU session

Secondary Outcomes (12)

• Urinary continence

  1, 3, 6 and 12 months post-treatment

• Urinary continence variation

  at 1, 3, 6 and 12 months post-treatment

• Urinary continence proportion

  1,3, 6, and 12 months post-treatment

• Urinary voiding function variation

  1,3, 6, and 12 months post-treatment

• Erectile function

  1, 3, 6 and 12 months post-treatment

Study Arms (1)

ADT protocol

EXPERIMENTAL

ADT protocol is administered as a single subcutaneous injection of 3-month depot of 22.5 mg of leuprolide acetate (luteinizing hormone-releasing hormone \[LHRH\] agonist). ADT protocol starts one month prior to the scheduled HIFU session. The intervention of the study is HIFU hemi-ablation combined with ADT.

Drug: HIFU hemi-ablation combined with ADT.

Interventions

HIFU hemi-ablation combined with ADT. DRUG

Hemi-ablation of the cancer-harbouring prostatic lobe will be carried out using HIFU energy. Short-term 3-month ADT will be administered concomitantly. Short-term ADT is administered as a single subcutaneous injection of 3-month depot of 22.5 mg of leuprolide acetate (luteinizing hormone-releasing hormone \[LHRH\] agonist). The ADT protocol starts within 1 month prior to the scheduled HIFU session

ADT protocol

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men aged 40 and over.
• Life expectancy ≥ 10 years.
• Localized, intermediate-risk PCa (according to the most recent version of the European Association of Urology Prostate Cancer Guidelines).
• PI-RADS ≥ 3 lesions in MRI (PI-RADS v2.1).
• Unilateral (unifocal or multifocal) PCa or bilateral disease allowing unilateral GS 3+3 up to 1mm in the non-treated side.
• Histopathologically verified PCa by any mpMRI-targeted prostate biopsy (3 cores per each target lesion + 12 random cores performed).
• Any Gleason score 7 (3 + 4) (ISUP2).
• Prostate specific antigen (PSA) ≤15 ng/ml.
• Clinical stage T1c-T2b (based on MRI and/or rectal examination).
• Absence of lymph node and distant metastases.
• Prostate volume ≤ 60 ml. Patient with prostate volume between 40 ml and 60 ml could be included only if lesion is located in posterior zone of the prostate.
• Treatment-naive patients (received no previous treatments for PCa, apart from active surveillance).
• World Health Organization (WHO) performance status of grade 0-2.
• Men who are sexually active with women of chidbearing potential must use a highly effective method of contraception prior the first administration of hormonal therapy and must agree to continue using such precautions for 130 days after the final administration of the treatment.
• Having signed a written informed consent form.

You may not qualify if:

• Men under the age of 40.
• Life expectancy less than 10 years.
• Any Gleason score ≤6 (3 + 3) (ISUP1).
• Any Gleason score≥ 7 (4+3) (ISUP3).
• PI-RADS \< 3 lesions in MRI (PI-RADS v2.1).
• Apex lesions may ≥ 10 mm away from the urethral sphincter.
• PSA \>15 ng/ml.
• Clinical stage \> cT2b (based on MRI and rectal examination).
• Evidence of extra-prostatic extension or seminal vesicle invasion.
• Evidence of lymph node or distant metastases.
• Prostate volume \> 40 ml when lesion is located in the anterior zone of the prostate.
• Prostatic calcifications or cysts whose location may interfere with effective delivery of HIFU energy.
• Metal implants/stents in the urethra.
• Active urinary tract infection.
• Men who have previously received any form of PCa treatment (e.g. external beam radiation therapy (EBRT), brachytherapy, HIFU, cryosurgery, thermal or microwave therapy and/or hormonal therapy).

Sponsors & Collaborators

• Institut Mutualiste Montsouris: lead
• University of Turin, Italy: collaborator

Study Sites (1)

Institut Mutualiste Montsouris

Paris, 75014, France

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Androgen Antagonists

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Lara RODRIGUEZ-SANCHEZ, Doctor

  Institut Mutualiste Montsouris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lara RODRIGUEZ-SANCHEZ, Doctor

CONTACT

+33156616650; lara.rodriguez-sanchez@imm.fr

Giancarlo Marra, Doctor

CONTACT

drgiancarlomarra@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: February 19, 2019
• Study Start: January 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: January 12, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)