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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier:
NCT00928603
First received: June 25, 2009
Last updated: September 14, 2009
Last verified: September 2009
  Purpose

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 Intervention Phase
Prostate Cancer
Procedure: Focal Cryoablation
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Focal Therapy for Organ Confined Prostate Cancer: an Investigative Prospective Pilot Study

Resource links provided by NLM:


Further study details as provided by Università Vita-Salute San Raffaele:

Primary Outcome Measures:
  • Feasibility, Safety, Tolerability (patient's complying with the follow-up), and Oncological efficacy [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in QoL instruments (IPSS/IIEF/FACT-P/MSHQ) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: September 2009
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cryotherapy
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

Detailed Description:

Prostate cancer is a considerable health risk for men throughout the world. In the United States, prostate cancer has been the second or third leading cause of cancer death in men in each of the last 75 years. In the European Union, an estimated 68,000 men died of prostate cancer in 2004, making it the third most common cause of cancer related death While prostate cancer mortality in East Asian countries remains lower than that in Europe and the United States, it has been continuously and dramatically increasing in the last 40 years. With the introduction of PSA screening test and transrectal ultrasound guided prostate biopsy, the detection rate of prostate carcinoma has markedly improved. Surgery and irradiation each provide excellent long-term cancer control but they may be accompanied by a risk of side effects that decrease quality of life. Since some of prostate cancers grow slowly and, even if untreated, might never progress to symptomatic disease, patients and clinicians face the dilemma of if, when and how to treat localized prostate cancer. Due to the stage migration of prostate cancer, the potential for patients to undergo unnecessary treatment and the risk of treatment related morbidity, there has been, in the last years, an increased interest in alternative strategies that offer the possibility of delaying, obviating or minimizing the impact of treatment maintaining the same oncological long term results. One such strategy is active surveillance with selective delayed intervention. Active surveillance consists of appropriate selection of patients to safely avoid radical treatment and its attendant potential for morbidity, regular and rigorous monitoring of the cancer via physical examination, PSA, biopsies and imaging and initiation of treatment with curative intent at any clinical, pathological or radiographic evidence of disease progression. Despite pros and cons have recently addressed, active surveillance has not gained popularity in men with low risk prostate cancer (only around 7% of men with localized prostate cancer in the Cancer of the Prostate Strategic Urologic Research Endeavor national registry have elected to undergo active surveillance as the initial treatment options). 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. We 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.

  Eligibility

Ages Eligible for Study:   18 Years to 76 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00928603

Locations
Italy
Department of Urology University "Vita e Salute" HSR
Milano, Italy, 50127
Sponsors and Collaborators
Università Vita-Salute San Raffaele
Investigators
Study Director: Giorgio Guazzoni, MD University "Vita e Salute" San Raffaele Milano
  More Information

No publications provided

Responsible Party: Prof. Guazzoni Giorgio, Department of Urology, University "Vita Salute" San Raffaele Milan
ClinicalTrials.gov Identifier: NCT00928603     History of Changes
Other Study ID Numbers: U-HSR-VT-001
Study First Received: June 25, 2009
Last Updated: September 14, 2009
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Università Vita-Salute San Raffaele:
prostate cancer
therapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 23, 2014