Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Anesthetics, General

The Interstitial Laser Thermal Therapy (LTT) procedure is similar to brachytherapy, with fibers and probes inserted trans-perineal using transrectal ultrasound guidance. Patients will be under general anesthetic, and the procedure is expected to last 3 hours. Patients will be able to return home the day of the procedure.

MRI Targeted Focal Thermal Therapy of Prostate Cancer

John Trachtenberg, M.D.

The objective of this study is to establish the safety of MRI targeted laser thermal treatment for men with biopsy confirmed early stage low grade single sector prostate cancer.

This is a single center, single arm, open-label Phase I study to establish the safety of interstitial laser thermal therapy (ILTT) in patients with a single site of low grade (Gleason \<7) prostate cancer who have not yet received treatment for their cancer. No control group will be utilized and all patients will receive laser thermal therapy. The patient will undergo multimode MRI to determine if a single site of prostate cancer can be localized by this technique and to localize the tumor in 3 dimensions within the prostate. A multicore (12 + cores) mapping transrectal ultrasound guided biopsy of the prostate would then confirm that no other sites of cancer exist.

Each patient will complete quality of life and performance questionnaires. ILLT will be performed under general anesthetic in a procedure similar to brachytherapy, using transrectal ultrasound to guide insertion of the laser and monitoring probes into the sector containing the cancer as visualized by the MR scan. Following the procedure, patients will be assessed for clinical signs of urinary, rectal, and erectile complications and will complete validated self-assessment tools on these functions. MRI at 7 days and MRI and biopsy at 6 months will be used to assess the extent of tissue effect and presence of cancer due to ILTT. Patients will remain on standard Watchful Waiting surveillance for any further sign of disease progression. ILLT will not restrict any future treatment of prostate cancer.

To minimize the treatment risk, participants in the trial will be staged according to location of the disease in the prostate. The first 3 participants recruited to the trial will have targeted loci well separated from the urethra, erectile nerves and the rectum, and so treatment in this region poses minimal risk of injury to these vital structures. Lesions sizes measured in this initial stage will be used in planning fiber placement in the three remaining stages, in which fiber placement is closer to critical structures such as the urethra (Stage 2), erectile nerves (Stage 3) and rectum (Stage 4).

MRI Targeted Focal Laser Thermal Therapy of Biopsy Confirmed Prostate Cancer

Phase 1 Study of MRI Targeted Focal Laser Thermal Therapy of Biopsy Confirmed Prostate Cancer

University Health Network, Toronto

Dr. John Trachtenberg

Enrolled subjects will undergo the ablative therapy as part of their standard of care treatment

Sonobia Garrett

Xiaosong Meng, MD, PhD

This study will be designed to define the efficacy and safety of ablative therapies in the management of localized prostate cancer and comprehensively evaluate quality of life outcomes and oncologic control following treatment.

This study will be designed to define the efficacy and safety of ablative therapies in the management of localized prostate cancer and comprehensively evaluate quality of life outcomes and oncologic control following treatment.

There are several commercially available standard of care treatments available for local therapy of the prostate. Ablative therapies may be delivered via a whole gland or focal approach by systems including cryoablation (CA), brachytherapy, irreversible electroporation (IRE), high intensity focused ultrasound (HIFU), MRI-guided transurethral ultrasound ablation (TULSA) procedure or future novel prostate ablation systems.

These are single, outpatient treatments lasting between 2-4 hours and include treatment planning and energy delivery under guidance and are either administered via transperineally approach (cryoablation, IRE, brachytherapy) or via the urethral (TULSA-Pro) or rectum (HIFU).

This study protocol will not include experimental therapy and the enrolled subjects will undergo the ablative therapy as part of their standard of care treatment.

Outcomes of Focal Ablation for Prostate Cancer

Prospective Single Institutional Study Evaluating the Outcomes for Patients Undergoing Ablative Therapies in the Management of Clinically Localized Prostate Cancer in the Primary and Salvage Setting

We will plan on sharing patient demographics, treatment modality, treatment oncologic outcomes, post-treatment questionnaire data and adverse events. Specific patient identifiers will be removed.

Oncologic outcomes will be assessed by the rate of negative in-field biopsy at 12 months which is defined by the Delphi consensus criterion of absence of clinically significant disease (≤ 3 mm of Gleason ≤ 6 disease in any biopsy core is insignificant)

Oncologic outcomes will be assessed by the rate of advancement to systemic therapy or radical salvage therapies which is defined by prostatectomy, radiation or hormone therapy.

Oncologic outcomes will be assessed by the rate of progression to systemic therapy or radical salvage therapies which is defined by prostatectomy, radiation or hormone therapy.

Change in urinary function is measured by International Prostate Symptom Score (IPSS) questionnaire which measures urinary symptoms and continence and the scores range from 0 to 35. A change \> 3 points between baseline and follow-up assessments is defined as meaningful for the IPSS. Therefore, increases in IPSS scores larger than 3 points will be categorized as reduced urinary function (worse outcome).

Change in erectile function is measured by International Index of Erectile Function (IIEF-5) score questionnaire which classifies patients into five severity levels ranging from none (22-25 points) to severe (5-7 points). Patients whose IIEF-5 levels worsen from baseline to follow-up will be categorized as having reduced erectile function.

Adverse events (AE)s will be monitored and evaluated by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for 30 days post-treatment

An adverse event (AE) will be monitored and evaluated by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for up to 3 years post-treatment

Number of participants undergoing combined treatment of the transitional zone (TZ ) due to bladder outlet obstruction caused by BPH will be evaluated to determine efficacy of treatment of the transitional zone in patients with LUTS due to BPH via International Prostate Symptom Score (IPSS) questionnaire

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
MRI Targeted Focal Laser Thermal Therapy of Biopsy Confirmed Prostate Cancer	NCT00448695	Prostate Cancer	MRI Targeted Fo...	18 Years -	University Health Network, Toronto
MRI Targeted Focal Laser Thermal Therapy of Biopsy Confirmed Prostate Cancer	NCT00448695	Prostate Cancer	MRI Targeted Fo...	18 Years -	University Health Network, Toronto
Outcomes of Focal Ablation for Prostate Cancer	NCT05478694	Prostate Cancer		18 Years - 90 Years	University of Texas Southwestern Medical Center

Spots Global Cancer Trial Database for focal ablation