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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
EU CTIS ID: 2024-518680-36-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Men aged 40 and over
- 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 patient
- 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
- Localized intermediate-risk prostate cancer
- PI-RADS ≥ 3 lesions in MRI
You likely can't join if
- Apex lesions may be located ≥ 10 mm away from the urethral sphincter
- Men with congenital long QT syndrome, congestive heart failure, frequent electrolyte abnormalities, or taking drugs known to prolong the QT interval
- Pateints who previously underwent orchiectomy
- Men with any relative and/or absolute contraindication to receive androgen deprivation therapy
- Prostatic calcifications or cysts whose location may interfere with effective delivery of HIFU energy
- Metal implants/stents in the urethra
See the full eligibility criteria
- Men aged 40 and over
- 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 patient
- 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
- Localized intermediate-risk prostate cancer
- PI-RADS ≥ 3 lesions in MRI
- Unilateral (unifocal or multifocal) PCa or bilateral disease including unilateral Gleason score 3+3 in the not treated side
- Any Gleason score 7 (3+4) (ISUP 2)
- Prostate specific antigen (PSA) ≤15 ng/ml
- Clinical stage cT1c-T2b
- Absence of extra-prostatic extension or seminal vesicle invasion
- Absence of lymph node and distant metastases
- Apex lesions may be located ≥ 10 mm away from the urethral sphincter
- Men with congenital long QT syndrome, congestive heart failure, frequent electrolyte abnormalities, or taking drugs known to prolong the QT interval
- Pateints who previously underwent orchiectomy
- Men with any relative and/or absolute contraindication to receive androgen deprivation therapy
- 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
- Men with an inability to have MRI scanning
- Men with renal impairment and a glomerular filtration rate (GFR) of <35 ml/min (unable to tolerate Gadolinium dynamic contrast enhanced MRI)
- Hypersensitivity to leuprorelin acetate, to other GnRH agonists or to any of the excipients
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.