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Focal Therapy for the Treatment of Organ Confined Prostate Cancer

Phase 2
45 Years
Not Enrolling
Prostatic Neoplasms, Prostate Cancer

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Trial Information

Focal Therapy for the Treatment of Organ Confined Prostate Cancer

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.

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

Type of Study:


Study Design:

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

Outcome Measure:

Transrectal Ultrasound-guided prostate biopsy

Outcome Description:

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.

Outcome Time Frame:

yearly up to 5 years

Safety Issue:


Principal Investigator

James F Borin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Maryland


United States: Food and Drug Administration

Study ID:




Start Date:

Completion Date:

March 2018

Related Keywords:

  • Prostatic Neoplasms
  • Prostate Cancer
  • Focal therapy
  • Brachytherapy
  • Active surveillance
  • low risk cancer
  • Neoplasms
  • Prostatic Neoplasms



University of Maryland School of MedicineBaltimore, Maryland  21201-1619