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Low Dose Supplemental External Radiation With PD-103 Versus PD-103 Alone For Prostate Cancer


Phase 3
40 Years
80 Years
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

Low Dose Supplemental External Radiation With PD-103 Versus PD-103 Alone For Prostate Cancer


Approximately 250,000 men are currently diagnosed with prostatic cancer in the United States
each year. Of those, 70% have stage T1 or T2 disease (apparently limited to the prostate
gland). Clinically localized prostate cancer is a spectrum of disease, ranging from good
prognosis to poor prognosis. Patients with a PSA above 10 ng/ml or Gleason score of 7 to 10
are referred to as intermediate risk, with approximately an 80% chance of cure.

Implantation of radioactive sources directly into the prostate (brachytherapy) delivers a
high, localized radiation dose while sparing most the of the bladder and rectum.
Brachytherapy is well established for other tumor sites, and has become a standard treatment
for prostate cancer.

Establishing that a good quality implant alone is as effective as implant plus beam
radiation will allow us to routinely drop the use of beam radiation, a change in policy that
will decrease the risk of some complications, will be more convenient for patients, and will
lower treatment costs.


Inclusion Criteria:



- Patients with previously untreated prostatic cancer.

- Must have PSA 10-20 ng/ml, Gleason 7 to 9

Exclusion Criteria:

- Patients with proven regional lymph node involvement will be excluded.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Serial PSA : 6, 12, 18 and 24 months and then yearly.

Outcome Description:

Serial PSA : 6, 12, 18 and 24 months and then yearly.

Outcome Time Frame:

6, 12, 18 and 24 months and then yearly

Safety Issue:

No

Principal Investigator

Gregory S Merrick, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Schiffler Cancer Center, Wheeling, WV

Authority:

United States: Institutional Review Board

Study ID:

04-8-10

NCT ID:

NCT00241384

Start Date:

January 2005

Completion Date:

December 2013

Related Keywords:

  • Prostate Cancer
  • Prostatic Cancer
  • Brachytherapy
  • Prostatic neoplasm
  • Radiation therapy
  • Prostatic Neoplasms

Name

Location

Schiffler Cancer CenterWheeling, West Virginia  26003
Veterans Administration Puget Sound Health Care SystemSeattle, Washington  98108-1597