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

NCT00928603 | Unknown Phase 1 DMC

• 1 other identifier: U-HSR-VT-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

prostate cancer; therapy

Outcome Measures

Primary Outcomes (1)

• Feasibility, Safety, Tolerability (patient's complying with the follow-up), and Oncological efficacy

  5 years

Secondary Outcomes (1)

• Changes in QoL instruments (IPSS/IIEF/FACT-P/MSHQ)

  5 years

Study Arms (1)

cryotherapy

EXPERIMENTAL

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

Interventions

Focal Cryoablation PROCEDURE

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.

Also known as: Thermal ablative treatment

cryotherapy

Eligibility Criteria

• Age: 18 Years - 76 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Università Vita-Salute San Raffaele: lead

Study Sites (1)

Department of Urology University "Vita e Salute" HSR

Milan, 50127, Italy

Location

Related Publications (1)

• 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.

  PMID: 23522299 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Giorgio Guazzoni, MD

  University "Vita e Salute" San Raffaele Milano

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 25, 2009
• First Posted: June 26, 2009
• Study Start: September 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2014
• Last Updated: September 15, 2009

Record last verified: 2009-09

Locations

IT (1)