Clinical trial · Observational
Focal Laser Ablation in Prostate Cancer
Transperineal Targeted Focal Laser Ablation of Localized Intermediate Risk Prostatic Adenocarcinoma (Pilot Study)
NCT06916013CI-TRIAL-00088265not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Laser | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Focal laser ablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Prostatic adenocarcinoma
- description
- Localized intermediate-risk prostatic adenocarcinoma
- interventionNames
- Procedure: Focal laser ablation
Primary outcomes (1)
- measure
- Evaluation of short-term oncological outcome
- timeFrame
- 12 months
- description
- 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.
Secondary outcomes (1)
- measure
- Evaluation of functional outcome.
- timeFrame
- 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
Show eligibility criteria text
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
References
Publications (8)
- RESULTMottet N, van den Bergh RCN, Briers E, Van den Broeck T, Cumberbatch MG, De Santis M, Fanti S, Fossati N, Gandaglia G, Gillessen S, Grivas N, Grummet J, Henry AM, van der Kwast TH, Lam TB, Lardas M, Liew M, Mason MD, Moris L, Oprea-Lager DE, van der Poel HG, Rouviere O, Schoots IG, Tilki D, Wiegel T, Willemse PM, Cornford P. EAU-EANM-ESTRO-ESUR-SIOG Guidelines on Prostate Cancer-2020 Update. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2021 Feb;79(2):243-262. doi: 10.1016/j.eururo.2020.09.042. Epub 2020 Nov 7. PMID 33172724
- RESULTValerio M, Cerantola Y, Eggener SE, Lepor H, Polascik TJ, Villers A, Emberton M. New and Established Technology in Focal Ablation of the Prostate: A Systematic Review. Eur Urol. 2017 Jan;71(1):17-34. doi: 10.1016/j.eururo.2016.08.044. Epub 2016 Aug 29. PMID 27595377
- RESULTAhmed HU. The index lesion and the origin of prostate cancer. N Engl J Med. 2009 Oct 22;361(17):1704-6. doi: 10.1056/NEJMcibr0905562. No abstract available. PMID 19846858
- RESULTEggener S, Salomon G, Scardino PT, De la Rosette J, Polascik TJ, Brewster S. Focal therapy for prostate cancer: possibilities and limitations. Eur Urol. 2010 Jul;58(1):57-64. doi: 10.1016/j.eururo.2010.03.034. Epub 2010 Mar 26. PMID 20378241
- RESULTLindner U, Trachtenberg J, Lawrentschuk N. Focal therapy in prostate cancer: modalities, findings and future considerations. Nat Rev Urol. 2010 Oct;7(10):562-71. doi: 10.1038/nrurol.2010.142. Epub 2010 Sep 14. PMID 20842187
- RESULTHamdy FC, Donovan JL, Lane JA, Mason M, Metcalfe C, Holding P, Davis M, Peters TJ, Turner EL, Martin RM, Oxley J, Robinson M, Staffurth J, Walsh E, Bollina P, Catto J, Doble A, Doherty A, Gillatt D, Kockelbergh R, Kynaston H, Paul A, Powell P, Prescott S, Rosario DJ, Rowe E, Neal DE; ProtecT Study Group. 10-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer. N Engl J Med. 2016 Oct 13;375(15):1415-1424. doi: 10.1056/NEJMoa1606220. Epub 2016 Sep 14.