Focal Laser Ablation in Prostate Cancer

NCT06916013 | Not Yet Recruiting

• 1 other identifier: Laser in prostate cancer
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Prostate Cancer; Laser

Keywords

Prostate cancer; Laser

Outcome Measures

Primary Outcomes (1)

• Evaluation of short-term oncological outcome

  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 Outcomes (1)

• Evaluation of functional outcome.

  12 months

Study Arms (1)

Prostatic adenocarcinoma

Localized intermediate-risk prostatic adenocarcinoma

Procedure: Focal laser ablation

Interventions

Focal laser ablation PROCEDURE

Targeted focal laser ablation

Prostatic adenocarcinoma

Eligibility Criteria

• Age: 45 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Males with localized, intermediate risk prostatic adenocarcinoma

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Related Publications (8)

• Mottet 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 RESULT

• Valerio 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 RESULT

• Ahmed 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 RESULT

• Eggener 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 RESULT

• Lindner 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 RESULT

• Hamdy 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.

  PMID: 27626136 RESULT

• Donovan JL, Hamdy FC, Lane JA, Mason M, Metcalfe C, Walsh E, Blazeby JM, Peters TJ, Holding P, Bonnington S, Lennon T, Bradshaw L, Cooper D, Herbert P, Howson J, Jones A, Lyons N, Salter E, Thompson P, Tidball S, Blaikie J, Gray C, Bollina P, Catto J, Doble A, Doherty A, Gillatt D, Kockelbergh R, Kynaston H, Paul A, Powell P, Prescott S, Rosario DJ, Rowe E, Davis M, Turner EL, Martin RM, Neal DE; ProtecT Study Group*. Patient-Reported Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer. N Engl J Med. 2016 Oct 13;375(15):1425-1437. doi: 10.1056/NEJMoa1606221. Epub 2016 Sep 14.

  PMID: 27626365 RESULT

• Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

  PMID: 33538338 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: April 8, 2025
• Study Start: April 20, 2025
• Primary Completion (Estimated): April 20, 2027
• Study Completion (Estimated): August 20, 2027
• Last Updated: April 8, 2025

Record last verified: 2025-04