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Investigative Study of the Role of Focal Therapy for Prostate Cancer Treatment

NCT00928603 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2009-09-15

No results posted yet for this study

Summary

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

Interventions

PROCEDURE

Focal Cryoablation

Cryotherapy is administered via the perineum under ultrasound guidance by third-generation 17-gauge cryoprobes using gas and thermal couples. Under transrectal ultrasound guidance cryoprobes are placed approximately 1 cm apart and within 5 mm of the capsule on the side of tumor. The extent of freezing was limited to the area or lobe of the gland with histologically proved tumor.

Sponsors & Collaborators

  • Università Vita-Salute San Raffaele

    lead OTHER

Principal Investigators

  • Giorgio Guazzoni, MD · University "Vita e Salute" San Raffaele Milano

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
76 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-09-30
Completion
2014-09-30

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00928603 on ClinicalTrials.gov