Investigative Study of the Role of Focal Therapy for Prostate Cancer Treatment
Primary Purpose
Prostate Cancer
Status
Unknown status
Phase
Phase 1
Locations
Italy
Study Type
Interventional
Intervention
Focal Cryoablation
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, therapy
Eligibility Criteria
Inclusion Criteria:
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
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%)
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:
- Tumor in the transitional zone
- Previous prostate surgery for benign pathology
- Any rectal or perineal pathology hampering instrumentation and manipulation of the area
- Benign or malignant rectal lesion
- 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.
Sites / Locations
- Department of Urology University "Vita e Salute" HSR
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
cryotherapy
Arm 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
Outcomes
Primary Outcome Measures
Feasibility, Safety, Tolerability (patient's complying with the follow-up), and Oncological efficacy
Secondary Outcome Measures
Changes in QoL instruments (IPSS/IIEF/FACT-P/MSHQ)
Full Information
NCT ID
NCT00928603
First Posted
June 25, 2009
Last Updated
September 14, 2009
Sponsor
Università Vita-Salute San Raffaele
1. Study Identification
Unique Protocol Identification Number
NCT00928603
Brief Title
Investigative Study of the Role of Focal Therapy for Prostate Cancer Treatment
Official Title
Focal Therapy for Organ Confined Prostate Cancer: an Investigative Prospective Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2010 (Anticipated)
Study Completion Date
September 2014 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Università Vita-Salute San Raffaele
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer, therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cryotherapy
Arm Type
Experimental
Arm 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
Intervention Type
Procedure
Intervention Name(s)
Focal Cryoablation
Other Intervention Name(s)
Thermal ablative treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility, Safety, Tolerability (patient's complying with the follow-up), and Oncological efficacy
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Changes in QoL instruments (IPSS/IIEF/FACT-P/MSHQ)
Time Frame
5 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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%)
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:
Tumor in the transitional zone
Previous prostate surgery for benign pathology
Any rectal or perineal pathology hampering instrumentation and manipulation of the area
Benign or malignant rectal lesion
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giorgio Guazzoni, MD
Organizational Affiliation
University "Vita e Salute" San Raffaele Milano
Official's Role
Study Director
Facility Information:
Facility Name
Department of Urology University "Vita e Salute" HSR
City
Milano
ZIP/Postal Code
50127
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
23522299
Citation
Losa 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.
Results Reference
derived
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Investigative Study of the Role of Focal Therapy for Prostate Cancer Treatment
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