Investigative Study of the Role of Focal Therapy for Prostate Cancer Treatment
|ClinicalTrials.gov Identifier: NCT00928603|
Recruitment Status : Unknown
Verified September 2009 by Università Vita-Salute San Raffaele.
Recruitment status was: Enrolling by invitation
First Posted : June 26, 2009
Last Update Posted : September 15, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Procedure: Focal Cryoablation||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Focal Therapy for Organ Confined Prostate Cancer: an Investigative Prospective Pilot Study|
|Study Start Date :||September 2009|
|Estimated Primary Completion Date :||September 2010|
|Estimated Study Completion Date :||September 2014|
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
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.
Other Name: Thermal ablative treatment
- Feasibility, Safety, Tolerability (patient's complying with the follow-up), and Oncological efficacy [ Time Frame: 5 years ]
- Changes in QoL instruments (IPSS/IIEF/FACT-P/MSHQ) [ Time Frame: 5 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00928603
|Department of Urology University "Vita e Salute" HSR|
|Milano, Italy, 50127|
|Study Director:||Giorgio Guazzoni, MD||University "Vita e Salute" San Raffaele Milano|