Micro‑ultrasound guided focal laser treatment for intermediate‑risk prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single‑arm, prospective 6‑month interventional protocol using transperineal interstitial laser ablation guided by micro‑ultrasound (TRANBERG|CLS system). Men with histologically proven intermediate‑risk prostate cancer and MRI/MicroUS‑visible tumors ≤15 mm confined to one lobe will be enrolled and treated. The study will track safety, functional outcomes (IPSS, ICIQ‑UI‑SF, IIEF‑15), and whether definitive treatments (radical prostatectomy or radiation) can be deferred. The aim is to determine whether micro‑ultrasound guidance can make focal laser therapy simpler and more widely available outside MRI‑dependent centers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Men 40-80 years of age.
* Histologically-proven intermediate-risk PCa (Gleason score 7, primary grade ≤ 4).
* PCa clinical stage T1c or T2.
* MRI/MicroUS site suspicious for cancer or cancer mapped to one prostate lobe.
* Maximum dimension of MRI/MicroUS visible tumour ≤15mm.
* Suspicious site on Prostate MRI/MicroUS must coincide with sector positive for cancer on biopsy.
* Prostate specific antigen (PSA) level \< 15 ng/mL.
* IPSS, ICIQ-UI-SF, IIEF-15 questionnaires completed prior to the procedure.
* Life expectancy of greater than 10 years, based on co-morbidity not related to PCa.

Exclusion Criteria:

* Maximum dimension of MRI/MicroUS visible tumour \> 15 mm.
* Patients medically unfit for focal therapy of the prostate.
* Patients who are unwilling or unable to give informed consent.
* Patients who have received androgen suppression therapy.
* Patients who have received or are receiving chemotherapy for prostate carcinoma.
* Patients previously treated with surgery to the prostate (traditional, endoscopic or minimally invasive) including HIFU, TUNA, RITA, microwave, cryotherapy or any curative treatment.
* Patients who have undergone radiation therapy for PCa or to the pelvis.
* Any condition or history of illness or surgery that, in the opinion of the Investigator, might confound the results of the study or pose additional risks to the patient (e.g. significant cardiovascular conditions or allergies).
* Patients with a history of non-compliance with medical therapy and/or medical recommendations.
* Patients who are unwilling or unable to complete the patient self-assessment questionnaires.
* Chronic or acute prostatitis, neurogenic bladder, urinary tract infection, sphincter abnormalities, or any other symptom that prevents normal micturition.
* Patients who have participated in a clinical study and/or received treatment with an investigational treatment and/or product within the past 90 days.
* Patients with contraindication to MRI (i.e. pacemaker, hip prosthesis, severe claustrophobia, brain aneurysm clip, allergy to MRI contrast agent)

Where it's running

• University Health Network - Princess Margaret Cancer Centre
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Sangeet Ghai, MD — The Princess Margaret Cancer Foundation
• Study coordinator: Kateri Corr
• Email: kateri.corr@uhn.ca
• Phone: 416-946-4501

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Adaptive intraoperative biopsy system for prostate cancer using imaging and metabolic feedback

  Aiming to test a smart biopsy approach that combines preoperative imaging with real-time metabolic signals to guide where to take prostate biopsy cores for better precision in men suspected of prostate cancer.

  Recruiting at 4 sites Shanghai Zhongshan Hospital · Shanghai and 3 other locations · NCT07856017

• MRT-2359 plus apalutamide in advanced prostate cancer

  This Phase 2 trial tests whether taking MRT-2359 with apalutamide can lower PSA in men with castration-resistant prostate cancer.

  Recruiting at 7 sites Phase 2 Monte Rosa Therapeutics, Inc · Los Angeles, California and 13 other locations · NCT07745361

• Predicting prostate cancer response to neoadjuvant darolutamide with a gene biomarker

  This study tests whether a gene-based PCAI ImmunoScore can predict which high-risk localized or locally advanced prostate cancer patients will have minimal residual disease after 90–120 days of darolutamide before surgery.

  Recruiting at 2 sites Phase 2 Region Stockholm · Gothenburg and 1 other locations · NCT07617272

• Personal preferences for avoiding gynecomastia (Stage 1)

  This project will ask men with prostate cancer and high-risk biochemical recurrence what trade-offs they'd make to avoid breast-related side effects like gynecomastia.

  Recruiting St Vincent's Hospital, Sydney · Sydney, New South Wales · NCT07552922

• LaserSAFE: Quick in OR imaging to check margins during prostatectomy

  A new in‑the‑operating‑room imaging method called LaserSAFE is tested to see if it can quickly detect cancer at the edge of the prostate during surgery for patients undergoing robot-assisted prostatectomy.

  Recruiting University College, London · London · NCT07541911

• Early postoperative PSA after prostate removal as a predictor of cancer outcomes

  We will test whether early PSA levels after prostate removal can help predict long-term cancer outcomes in men undergoing radical prostatectomy.

  Recruiting Lithuanian University of Health Sciences · Kaunas, Kauno · NCT07516886

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.