Leuprorelin acetate for Prostate cancer | Intermediate-risk localized prostate cancer

Inclusion criteria

• {"criterion_text":"- Men aged 40 and over\n- Localized intermediate-risk prostate cancer\n- PI-RADS ≥ 3 lesions in MRI\n- Unilateral (unifocal or multifocal) PCa or bilateral disease including unilateral Gleason score 3+3 in the not treated side\n- Any Gleason score 7 (3+4) (ISUP 2)\n- Prostate specific antigen (PSA) ≤15 ng/ml\n- Clinical stage cT1c-T2b\n- Absence of extra-prostatic extension or seminal vesicle invasion\n- Absence of lymph node and distant metastases\n- 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\n- Treatment naive patient\n- 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"}

Exclusion criteria

• {"criterion_text":"- Apex lesions may be located ≥ 10 mm away from the urethral sphincter\n- Prostatic calcifications or cysts whose location may interfere with effective delivery of HIFU energy\n- Metal implants/stents in the urethra\n- Active urinary tract infection\n- Patient treated with 5 α-reductase inhibitors in the previous 3 months and during the study\n- Men who have undergone surgery for benign prostatic hyperplasia in the previous 6 months\n- Men with an inability to have MRI scanning\n- Men with renal impairment and a glomerular filtration rate (GFR) of <35 ml/min (unable to tolerate Gadolinium dynamic contrast enhanced MRI)\n- Hypersensitivity to leuprorelin acetate, to other GnRH agonists or to any of the excipients\n- Men with congenital long QT syndrome, congestive heart failure, frequent electrolyte abnormalities, or taking drugs known to prolong the QT interval\n- Pateints who previously underwent orchiectomy\n- Men with any relative and/or absolute contraindication to receive androgen deprivation therapy"}

Primary endpoints

• {"endpoint_text":"- Proportion of treatment failure 12 months after HIFU treatment, identified as men harbouring clinically significant prostate cancer in treated and/or untreated areas of the prostate","definition_or_measurement_approach":"Treatment failure assessed at 12 months after HIFU; identified by presence of clinically significant prostate cancer in treated and/or untreated prostate areas (clinical/pathological assessment as per protocol)."}

Secondary endpoints

• {"endpoint_text":"- Biological results: serum PSA and testosterone levels at 1, 3, 6 and 12 months post-treatment","definition_or_measurement_approach":"Serum PSA and testosterone measured at 1, 3, 6 and 12 months post-treatment."}
• {"endpoint_text":"- Erectile function : IIEF-5 score changes at differrent time ponts post-treatment, as comared to baseline, proportion of men cho are potent at baseline and then sustain erectile dysfunction","definition_or_measurement_approach":"IIEF-5 score changes measured at specified post-treatment time points compared to baseline; proportion analysis for men potent at baseline who develop sustained erectile dysfunction."}
• {"endpoint_text":"- Ejaculatory function: MSHQ-EjD score changes at different time points post-treatment as compared to baseline","definition_or_measurement_approach":"MSHQ-EjD score changes measured at specified time points versus baseline."}
• {"endpoint_text":"- Continence at 1, 3, 6 and 12 months post-treatment as compared to baseline : changes of ICSmaleIS score, at differrent time points post-treatment; proportion of continent men","definition_or_measurement_approach":"ICSmaleIS score changes at 1, 3, 6 and 12 months compared with baseline; proportion of men classified as continent."}
• {"endpoint_text":"- Voiding function at 1, 3, 6 and 12 months post-treatment: changes of IPSS score at different time points post-treatment as compared to baseline","definition_or_measurement_approach":"IPSS score changes measured at 1, 3, 6 and 12 months versus baseline."}
• {"endpoint_text":"- Quality of life at 1, 3, 6 and 12 months post-treatment: changes of the EQ-5D-5L score at different time points post-treatment","definition_or_measurement_approach":"EQ-5D-5L score changes at specified time points compared to baseline."}
• {"endpoint_text":"- Complications / treatment-related toxicity","definition_or_measurement_approach":"Assessment and reporting of complications and treatment-related toxicity per protocol-specified criteria (timing and grading not specified in CTIS JSON)."}
• {"endpoint_text":"- Secondary intervention : proportion of men requiring salvage secondary prostate cancer intervention due to treatment failure","definition_or_measurement_approach":"Proportion of participants requiring salvage secondary prostate cancer intervention due to treatment failure, assessed over follow-up period."}

France

Earliest CTIS Part Ii Submission Date

16-10-2024

Latest Decision Or Authorization Date

25-10-2024

Processing Time Days

9

Number Of Sites

1

Number Of Participants

20

Primary sponsor

Full Name

Institut Mutualiste Montsouris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France