Status:
UNKNOWN
EvaluatioN of HIFU Hemiablation and Short Term AndrogeN Deprivation Therapy Combination to Enhance Prostate Cancer Control.
Lead Sponsor:
Institut Mutualiste Montsouris
Collaborating Sponsors:
University of Turin, Italy
Conditions:
Prostate Cancer
Androgen Deprivation Therapy
Eligibility:
MALE
40-80 years
Phase:
PHASE2
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 target...
Detailed Description
Prostate Cancer (PCa) is a multifocal disease in up to 90% of men with heterogeneity among different cancer foci in the same prostate gland. An index/dominant lesion has been proposed, namely the larg...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
- Patient treated with 5 α-reductase inhibitors in the previous 3 months and during the study.
- 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.
- Hypersensitivity to leuprorelin acetate, to other GnRH agonists or to any of the excipients.
- Men with congenital long QT syndrome, congestive heart failure, frequent electrolyte abnormalities, or taking drugs known to prolong the QT interval.
- Patients who previously underwent orchidectomy.
- 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.
- Men with relative and/or absolute contraindications to androgen deprivation therapy.
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03845751
Start Date
January 1 2023
End Date
January 1 2025
Last Update
January 12 2023
Active Locations (1)
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1
Institut Mutualiste Montsouris
Paris, France, 75014