Evaluation of High-Intensity Focused Ultrasound (HIFU) Hemi-ablation and short-term androgen deprivation therapy combination to enhance prostate control for intermediate risk localized prostate cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Institut Mutualiste Montsouris, Institut Mutualiste Montsouris

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

7 Mar 2023 → ongoing

Decision date (initial)

2024-10-25

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Institut Mutualiste Montsouris

External identifiers

EU CT number

2024-518680-36-00

EudraCT number

2022-002571-11

ClinicalTrials.gov

NCT03845751

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

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 objectives 7

1. Serum PSA levels changes at 1, 3, 6 and 12 months post-treatment
2. Erectile function at 1, 3, 6 and 12 months post-treatment
3. Ejaculatory function at 1, 3, 6 and 12 months post-treatment
4. Continence at 1, 3, 6 and 12 months post-treatment
5. Voiding function at 1, 3, 6 and 12 months post-treatment
6. Quality of life at 1, 3, 6 and 12 months post-treatment
7. Secondary intervention

Conditions and MedDRA coding

Intermediate risk prostate cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 12

1. Men aged 40 and over
2. Localized intermediate-risk prostate cancer
3. PI-RADS ≥ 3 lesions in MRI
4. Unilateral (unifocal or multifocal) PCa or bilateral disease including unilateral Gleason score 3+3 in the not treated side
5. Any Gleason score 7 (3+4) (ISUP 2)
6. Prostate specific antigen (PSA) ≤15 ng/ml
7. Clinical stage cT1c-T2b
8. Absence of extra-prostatic extension or seminal vesicle invasion
9. Absence of lymph node and distant metastases
10. 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
11. Treatment naive patient
12. 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 12

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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

Secondary endpoints 8

1. Biological results: serum PSA and testosterone levels at 1, 3, 6 and 12 months post-treatment
2. 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
3. Ejaculatory function: MSHQ-EjD score changes at different time points post-treatment as compared to baseline
4. 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
5. 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
6. 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
7. Complications / treatment-related toxicity
8. Secondary intervention : proportion of men requiring salvage secondary prostate cancer intervention due to treatment failure

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Institut Mutualiste Montsouris

Sponsor organisation

Institut Mutualiste Montsouris

Address

42 Boulevard Jourdan

City

Paris

Postcode

75014

Country

France

Scientific contact point

Organisation

Institut Mutualiste Montsouris

Contact name

Lara RODRIGUEZ-SANCHEZ

Public contact point

Organisation

Institut Mutualiste Montsouris

Contact name

Naly ANDRIAMBAO

Institut Mutualiste Montsouris

Sponsor organisation

Institut Mutualiste Montsouris

Address

42 Boulevard Jourdan

City

Paris

Postcode

75014

Country

France

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications