Clinical trial NCT00241384: Low Dose Supplemental External Radiation With Pd-103 Versus Pd-103 Alone for Prostate Cancer
Official title: Low Dose Supplemental External Radiation With PD-103 Versus PD-103 Alone For Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: Prostatic Cancer
Brachytherapy
Prostatic neoplasm
Radiation therapy
Lead sponsor: Schiffler Cancer Center
Sponsor class: OTHER
Collaborators: name: Theragenics
name: University of Washington
First posted: 2005-10-18
Enrollment: 396
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to evaluate two treatment regimens for prostate cancer, prostate implant with 20 Gy of external beam radiation therapy versus prostate implant with 0 Gy of external beam radiation therapy. Patients diagnosed with intermediate risk prostate cancer between the ages of 40 and 80 who have chosen brachytherapy with or without external beam radiation therapy as their intended treatment will be eligible and will be offered participation.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Serial PSA : 6, 12, 18 and 24 months and then yearly.
timeFrame: 6, 12, 18 and 24 months and then yearly
measure: Post treatment biopsies in those with persistently elevated
timeFrame: as needed
measure: PSA which is suggestive of residual tumor.
timeFrame: as needed
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Veterans Administration Puget Sound Health Care System
state: Washington
city: Wheeling
country: United States
facility: Schiffler Cancer Center
state: West Virginia
Study officials:
affiliation: Schiffler Cancer Center, Wheeling, WV
name: Gregory S Merrick, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington VA Center
name: Kent E Wallner, MD
role: STUDY_CHAIR
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citation: Wallner K, Merrick G, Butler W, Sheretz T, Sutlief S, Cavanagh W, et al. 20 Gy versus 44 Gy supplemental beam radiation combined with Pd-103 prostate brachytherapy: early results from a prospective randomized multicenter trial (submitted)2004.
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