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

• Status: Not yet recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut Mutualiste Montsouris
• Collaborator: University of Turin, Italy
• Treatments: Androgens; Leuprolide; Prolactin Release-Inhibiting Factors

Criteria

Inclusion Criteria:

• Men aged 40-80 years (upper age limit is defined according to a life expectancy estimate being <10 years for men >80).

• Localized, intermediate- or low-risk PCa (according to the most recent version of the European Association of Urology Prostate Cancer Guidelines).

• 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) or systematic prostate biopsy (in case of a negative mpMRI), performed transperineally or transrectally).

• ≤3 biopsy cores demonstrating cancer involvement.

• <50% cancer involvement of any cancer harbouring core.

• Any Gleason score 7 (3 + 4) OR high-volume (>1.3 cc) Gleason score 6 (3+3).

• Prostate specific antigen (PSA) ≤15 ng/ml.

• Clinical stage T1c-T2a with no evidence of extra-prostatic extension/seminal vesicle invasion, N0M0 disease. (EAU guidelines)

• Prostate volume ≤ 50 ml.

• Treatment-naive patients (received no previous treatments for PCa, apart from active surveillance).

• World Health Organization (WHO) performance status of grade 0-2.

• Life expectancy of ≥10 years (G8 score ≥14 will be required in men >70 years)

Exclusion Criteria:

• Low-volume (<1.3 cc) Gleason score ≤6 (3 + 3) OR any Gleason score > 3+4

• 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 including 5 α-reductase inhibitors).

• Men who have undergone surgery for benign prostatic hyperplasia in the previous 6 months; i.e. a transurethral resection of the prostate (TURP), holmium laser enucleation (HOLEP), greenlight laser vaporization, others.

• Men with an inability to tolerate a transrectal ultrasound probe or have undergone prior significant rectal surgery preventing insertion of transrectal HIFU probe.

• Men unable to have MRI scanning (e.g. men with severe claustrophobia, permanent cardiac pacemaker or metallic implant which may likely contribute to significant image artefacts).

• Men with renal impairment and a glomerular filtration rate (GFR) of <35 ml/min (unable to tolerate Gadolinium dynamic contrast enhanced MRI).

• WHO performance status of grade 3-4 / men unfit for surgery

• Language barriers that might hinder the communications, understanding of written and verbal information about the trial, consenting process, or completing the questionnaires.

• Men refusing to sign an informed consent to participate in the trial.

• Concomitant cancers or previous cancers without a 5 years cancer free-status follow up.

• Men not reaching an androgen castration status at three months post-ADT administration will be included in the trial but not in the final analysis.

• Men with relative and/or absolute contraindications to androgen deprivation therapy.