Focal Therapy for Prostate Cancer

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2013 by University of Maryland
Sponsor:
Information provided by (Responsible Party):
James Borin, MD, University of Maryland
ClinicalTrials.gov Identifier:
NCT01802307
First received: February 26, 2013
Last updated: February 27, 2013
Last verified: February 2013
  Purpose

Prostate cancer is the most common solid organ cancer among men and is the second leading cause of cancer death. In 2013 about 238,590 men will be diagnosed with prostate cancer and 29,720 men will die of the cancer. Overall, about 1 in 6 men will be diagnosed with prostate cancer in their lifetime, but only 1 in 36 men will die. Currently, there are over 2.5 million men in the US living with prostate cancer. Standard treatment for prostate cancer has involved either removal of the prostate (radical prostatectomy) or application of some type of energy to the entire prostate gland in order to kill all of the cells--usually with radiation or cryotherapy (freezing).

Over the past decade, it has become apparent that while some men will benefit from treatment for prostate cancer, many will not. Particularly for men with a small amount of low-grade (not very aggressive) type of prostate cancer, the risk of death from this very slow-growing cancer is very low. However, the risk of harm from some of the treatments for prostate cancer is very high. Treatment for prostate cancer can cause erectile dysfunction, urinary leakage, difficulty urinating and overactive bladder and bowel symptoms.

One strategy for men with low risk prostate cancer has been to avoid immediate treatment and wait until the cancer starts to grow. The risk of this strategy is that some men may not be able to be cured once the cancer starts to grow. In addition, men who are on this active surveillance protocol can become very nervous, fearing that the cancer will start to spread.

A new strategy to avoid some of the treatment harms of prostate cancer while also attempting to avoid allowing the cancer to grow is called focal therapy. Many men with low-risk prostate cancer will have only a small piece of cancer within the prostate gland. These men may benefit from treating only this one area instead of the entire prostate. This will allow the physician to kill the cancer cells and to avoid some of the problems associated with treating the entire prostate.

The purpose of this study is to investigate the use of focal, targeted treatment of prostate cancer, that is, to treat only the small area of cancer instead of the entire prostate. We hope to show that this strategy will reduce the amount of side effects without compromising cancer cure.


Condition Intervention Phase
Prostatic Neoplasms
Prostate Cancer
Radiation: Brachytherapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Focal Therapy for the Treatment of Organ Confined Prostate Cancer

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Transrectal Ultrasound-guided prostate biopsy [ Time Frame: yearly up to 5 years ] [ Designated as safety issue: No ]
    Annual prostate biopsy will determine oncological efficacy of treatment of the primary lesion. A standard 12 core biopsy will be performed with an additional 2 cores directed toward the area that was treated. Outcomes will be reported as 1) Presence/absence of cancer in the treated location and 2) Presence of new cancer lesions in other portions of the prostate.


Secondary Outcome Measures:
  • Erectile function [ Time Frame: every 3-6 months for 5 years ] [ Designated as safety issue: No ]
    We will evaluate for any change from baseline and subsequent recovery of erectile function. Erectile function will be measured at baseline, then at 3-6 month intervals following treatment using a validated questionnaire, the International Index of Erectile Function (IIEF-5).

  • Urinary function/bother [ Time Frame: every 3-6 months up to 5 years ] [ Designated as safety issue: No ]
    We will evaluate the change from baseline and degree of recovery of urinary function using a validated questionnaire, the International Prostate Symptom Score. Incontinence will also be assessed as present/absent and the number of pads used, if any.


Estimated Enrollment: 50
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Focal Therapy Radiation: Brachytherapy
Other Name: Seeds

Detailed Description:

Prostate cancer is a lethal disease for ~11% of the men who are diagnosed with it. Early detection of prostate cancer using the PSA blood test can detect cancer a decade or more before it would have been found on a prostate examination. Men who are diagnosed at an older age (>75) may not benefit from aggressive treatment because many will not live long enough for the prostate cancer to kill them. Men who are diagnosed at a young age will be more likely to benefit from treatment from prostate cancer but they will have a very long time to live with some of the side effects of treatment.

Patients with low-risk prostate cancer, which is located in only one area or on one side of the prostate, may benefit from treatment of that one area instead of treating the entire prostate. This is similar to the lumpectomy of breast cancer which removes only the tumor instead of removing the entire breast.

This study will look at the short-term side-effects and the long-term success of performing focal treatment of prostate cancer.

Patients who are newly diagnosed with prostate cancer or who are already diagnosed and on an active surveillance protocol will be considered eligible for consideration of focal therapy. Patients deemed eligible will be offered inclusion in the study. There will only be a treatment group, no controls or placebo.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male
  • Age >44
  • Low risk Prostate Cancer (PSA <10, Gleason 6)
  • Low-volume intermediate risk prostate cancer (PSA <15, Gleason 3+4=7)
  • Organ confined disease

Exclusion Criteria:

  • Metastatic Disease
  • Palpable disease bilaterally
  • Locally advanced disease either by digital rectal exam or MRI
  • PSA >10 (for age <75)
  • PSA >15
  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: NCT01802307

Contacts
Contact: James F Borin, MD 410-328-6422 jborin@smail.umaryland.edu
Contact: Ganine Markowitz 410-328-7742 GMARKOWITZ@smail.umaryland.edu

Locations
United States, Maryland
University of Maryland School of Medicine Not yet recruiting
Baltimore, Maryland, United States, 21201
Contact: Borin    410-328-6422      
Principal Investigator: James F Borin, MD         
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: James F Borin, MD University of Maryland
Study Chair: Michael J Naslund, MD University of Maryland
  More Information

Publications:
Responsible Party: James Borin, MD, Assistant Professor of Surgery, University of Maryland
ClinicalTrials.gov Identifier: NCT01802307     History of Changes
Other Study ID Numbers: HP-00054478
Study First Received: February 26, 2013
Last Updated: February 27, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Maryland:
Focal therapy
Brachytherapy
Active surveillance
low risk cancer

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

ClinicalTrials.gov processed this record on July 10, 2014