Clinical trial · Interventional
Investigative Study of the Role of Focal Therapy for Prostate Cancer Treatment
Focal Therapy for Organ Confined Prostate Cancer: an Investigative Prospective Pilot Study
- 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)
Surgery and irradiation for organ confined prostate cancer provide excellent long-term cancer control but they may be accompanied by a risk of side effects that decrease quality of life. Due to the stage migration of prostate cancer, the potential for patients to undergo unnecessary treatment and the risk of treatment related morbidity, has been increased.Alternative strategies that offer the possibility of delaying, obviating or minimizing the impact of treatment maintaining the same oncological long term results have been investigated. Despite pros and cons active surveillance has not gained popularity in men with low risk prostate cancer as only 7% of men with localized prostate cancer remain in active surveillance. Traditionally solid tumors have been treated with radical surgery but selective, organ sparing therapies are now common for tumors of the breast, skin and kidney, resulting in equivalent rates of cancer control, lower morbidity rates and less disfigurement. With this in mind the potential role of focal ablative therapy for localized prostate cancer might be considered. The researchers will investigate the feasibility and the efficacy in term of quality of life and oncologic results of focal therapy by a pilot not randomized prospective study in a patients with localized prostate cancer who meet low risk criteria based on clinical, biopsy and imaging data.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Focal Cryoablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- cryotherapy
- description
- Focal Cryotherapy of localized tumor of prostate after spatial definition by in-house extended perineal core biopsy using a template biopsy strategy under local or general anesthesia
- interventionNames
- Procedure: Focal Cryoablation
Primary outcomes (1)
- measure
- Feasibility, Safety, Tolerability (patient's complying with the follow-up), and Oncological efficacy
- timeFrame
- 5 years
Secondary outcomes (1)
- measure
- Changes in QoL instruments (IPSS/IIEF/FACT-P/MSHQ)
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 76 Years
Show eligibility criteria text
Inclusion Criteria: 1. Clinical * Clinical stage T1c or T2a * PSA less than 10 ng/ml * PSA velocity less than 2 ng/ml yearly in the year prior to diagnosis 2. Biopsy * Minimum of 12 cores * No Gleason grade 4 or 5 * Maximum percentage of cancer in each core (20%) * Maximum length of cancer in each core ( 5 mm) * Maximum percentage of total cores with cancer (20%) 3. Imaging * Single lesion with a maximum size (12 mm) * Maximum length of capsular contact (10 mm) * No evidence of extraprostatic extension or seminal vesicle invasion Exclusion Criteria: 1. Tumor in the transitional zone 2. Previous prostate surgery for benign pathology 3. Any rectal or perineal pathology hampering instrumentation and manipulation of the area 4. Benign or malignant rectal lesion 5. Any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.
References
Publications (1)
- DERIVEDLosa A, Gadda GM, Lazzeri M, Lughezzani G, Cardone G, Freschi M, Lista G, Larcher A, Nava LD, Guazzoni G. Complications and quality of life after template-assisted transperineal prostate biopsy in patients eligible for focal therapy. Urology. 2013 Jun;81(6):1291-6. doi: 10.1016/j.urology.2012.11.078. Epub 2013 Mar 19. PMID 23522299