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Focal Therapy for Organ Confined Prostate Cancer: an Investigative Prospective Pilot Study

Phase 1
18 Years
76 Years
Open (Enrolling by invite only)
Prostate Cancer

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Trial Information

Focal Therapy for Organ Confined Prostate Cancer: an Investigative Prospective Pilot Study

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.

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

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Giorgio Guazzoni, MD

Investigator Role:

Study Director

Investigator Affiliation:

University "Vita e Salute" San Raffaele Milano


Italy: The Italian Medicines Agency

Study ID:




Start Date:

September 2009

Completion Date:

September 2014

Related Keywords:

  • Prostate Cancer
  • prostate cancer
  • therapy
  • Prostatic Neoplasms