Focal Laser Ablation in Prostate Cancer

April 4, 2025 updated by: Ain Shams University

Transperineal Targeted Focal Laser Ablation of Localized Intermediate Risk Prostatic Adenocarcinoma (Pilot Study)

To assess the effectiveness of MRI-US or PSMA PET/CT-U/S fusion-guided focal laser ablation (FLA) for the treatment of a localized, intermediate-risk prostate cancer in terms of short-term oncological & functional outcomes.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Prostate cancer (PCa) is the second most common neoplasm diagnosed in men with an estimated 1.4 million diagnoses and 375,000 deaths worldwide in 2020.

For localized prostate cancer (PCa), active surveillance (AS) or whole gland treatment (ie, radical prostatectomy [RP] and radiotherapy) are considered standard treatment options. Unfortunately, treatment-related morbidity is high.

The ProtecT trial showed urinary incontinence rates of 3% and 20% and erectile dysfunction rates of 66% and 79% for radiotherapy and radical prostatectomy, respectively. Radiotherapy can also cause rectal problems with a small increased risk of radiotherapy-induced secondary malignancy.

Consequently, over the past few years, there has been a notable escalation in scholarly attention towards the implementation of focal therapeutic interventions for patients diagnosed with low- and intermediate-risk prostate cancer (PCa).

This tissue-preserving strategy has at its core the reduction of treatment-related toxicity by minimizing damage caused to the prostate and adjacent structures while attempting to retain the benefits of treating cancer.

The rationale of focal therapy (FT) is based on the theory that the largest lesion with the highest grade, the so-called "index lesion," determines the risk of metastases and thus the patient's prognosis.

FT involves ablating only the index lesion, thereby minimizing damage to collateral tissue such as neurovascular bundles, external urinary sphincter, bladder neck and rectum.

Over the past few years, different types of energy sources in FT have been studied. These consist of high-intensity focused ultrasound (HIFU), irreversible electroporation (IRE), cryotherapy, photodynamic therapy (PDT), focal laser ablation (FLA) or laser interstitial thermotherapy, radiofrequency ablation (RFA), and focal brachytherapy.

According to the European Association of Urology (EAU), low-risk and intermediate-risk patients may undergo local procedures using HIFU or cryotherapy within clinical trials or registries, with the aim of achieving long-term cancer control and reducing morbidity associated with surgery and radiation therapy.

Many groups have published limited data on outcomes following in-bore MRI-guided focal therapy, and many others are actively engaged or considering prospective comparative effectiveness research in this area.

The primary objective encompasses a thorough evaluation of the short-term oncological & functional outcomes of MRI-US or PSMA PET/CT-U/S fusion-guided focal laser ablation (FLA) for the treatment of a small, localized, intermediate-risk prostate cancer.

Concurrently, the secondary aim involves an assessment of the utility of multiparametric magnetic resonance imaging (mpMRI) as a diagnostic pre-treatment tool and during the post-treatment follow-up to examine the morphostructural alterations in the prostate gland resulting from FLA. Additionally, the investigatirs aim to assess its reproducibility in determining the response to FLA therapy, correlating these findings with biopsy results, with the ultimate objective of establishing its predictive diagnostic value in identifying residual or recurring tumors.

Study Type

Observational

Enrollment (Estimated)

30

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Males with localized, intermediate risk prostatic adenocarcinoma

Description

Inclusion Criteria:

  • Prostate cancer visible on mpMRI or PSMA PET/CT and positive in the targeted biopsy.
  • Gleason score 7 (ISUP grade 2/3)
  • PSA 10-20 ng/mL
  • Clinical stage T2b
  • Refusing radical prostatectomy.

Exclusion Criteria:

  • Prostate cancer invisible on mpMRI or PSMA PET/CT but positive in the systematic biopsies.
  • Presence of >2 MRI-visible lesions and positive in the biopsies.
  • Extracapsular extension
  • Seminal vesicle invasion
  • Presence of metastases detected by imaging
  • Gleason Score > 7
  • Stage > T2b
  • PSA > 20 ng/mL
  • Urinary tract infection (UTI)
  • Severe lower urinary tract symptoms defined as an IPSS >20
  • Severe coagulation disorders
  • Inadequate compliance
  • Contraindications to MRI
  • Paramagnetic contrast agent allergy
  • Acute and/or chronic renal failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prostatic adenocarcinoma
Localized intermediate-risk prostatic adenocarcinoma
Procedure: Focal laser ablation
Targeted focal laser ablation
Procedure: Focal laser ablation
Targeted focal laser ablation of localized intermediate-risk prostate cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of short-term oncological outcome
Time Frame: 12 months
Follow-up with clinical evaluation performed by mpMRI. mpMRI is done for assessment of tissue changes as well as residual or recurrent disease after 10 days, then after 3 months, after 6 months then every 6 months thereafter.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of functional outcome.
Time Frame: 12 months
IIEF-5 questionnaire is submitted at 3, 6, 12 months.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 20, 2025

Primary Completion (Estimated)

April 20, 2027

Study Completion (Estimated)

August 20, 2027

Study Registration Dates

First Submitted

February 14, 2025

First Submitted That Met QC Criteria

April 4, 2025

First Posted (Actual)

April 8, 2025

Study Record Updates

Last Update Posted (Actual)

April 8, 2025

Last Update Submitted That Met QC Criteria

April 4, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Laser in prostate cancer

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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