E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Intermediate risk localized prostate cancer |
Cancer localisé de la prostate à risque intermédiaire |
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E.1.1.1 | Medical condition in easily understood language |
Intermediate risk prostate cancer |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036946 |
E.1.2 | Term | Prostatic cancer |
E.1.2 | System Organ Class | 100000004864 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
-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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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 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 any relative and/or absolute contraindication to receive androgen deprivation therapy, -Patients who previously underwent orchiectomy.
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
12 months after HIFU treatment |
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E.5.2 | Secondary end point(s) |
-Serum PSA level, -Serum testosterone level, -Erectile function, -Ejaculatory function, -Continence, -Voiding function, Quality of life, Secondary intervention. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1, 3, 6 and 12 months after HIFU treatment. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |