Intermediate risk localized prostate cancer MedDRA version: 21.0 Level: LLT Classification code 10036946 Term: Prostatic cancer System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Eligard 22.5mg
Pharmaceutical Form: Powder and solution for solution for injection
Sponsors
Institut Mutualiste Montsouris
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: -Men aged 40 and over, -Localized intermediate-risk prostate cancer, -Unilateral (unifocal or multifocal) PCa or bilateral disease including unilateral Gleason score 3+3 up to 1mm in the not treated side, -PI-RADS = 3 lesions in MRI (PI-RADS v2.1), -Any Gleason score 7 (3 + 4), -Prostate specific antigen (PSA) =15 ng/ml, -Clinical stage cT1c–T2b, -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), -Men who are sexually active with women of childbearing 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: -Apex lesions may be located = 10 mm away from the urethral sphincter, -Evidence of extra-prostatic extension or seminal vesicle invasion, -Evidence of lymph node or distant metastases, -Prostatic calcifications or cysts whose location may interfere with effective delivery of HIFU energy, -Metal implants/stents in the urethra, -Active urinary tract infection, -Patient treated with 5 a-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 any relative and/or absolute contraindication to receive androgen deprivation therapy, -Patients who previously underwent orchiectomy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To prospectively assess the oncologic efficacy, functional outcomes (erectile and ejaculatory functions, and urinary continence) and morbidity associated with HIFU hemiablation therapy in combination with concomitant short-term ADT for treatment of intermediate-risk localized prostate cancer.;Secondary Objective: -Serum PSA levels changes at 1, 3, 6 and 12 months post-treatment; -Serum PSA levels changes at 1, 3, 6 and 12 months post-treatment; -Erectile function at 1, 3, 6 and 12 months post-treatment; -Ejaculatory function at 1, 3, 6 and 12 months post-treatment; -Continence at 1, 3, 6 and 12 months post-treatment; -Voiding function at 1, 3, 6 and 12 months post-treatment; -Quality of life at 1, 3, 6 and 12 months post-treatment; -Secondary intervention.;Primary end point(s): Protortion of treatment failure, identified s men harbouring clinically significant prostate cancer in treated and/or untreated areas of the prostate. Proportion of men experiencing incontinence, erectile dysfunction, ejaculatory dysfunctionand complications/treatment related toxicity.;Timepoint(s) of evaluation of this end point: 12 months after HIFU treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Serum PSA level, -Serum testosterone level, -Erectile function, -Ejaculatory function, -Continence, -Voiding function, Quality of life, Secondary intervention.;Timepoint(s) of evaluation of this end point: 1, 3, 6 and 12 months after HIFU treatment. | — |
Countries
France
Contacts
Public ContactClinical research associate
Institut Mutualiste Montsouris
Outcome results
None listed