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Low Dose Supplemental External Radiation With Pd-103 Versus Pd-103 Alone for Prostate Cancer

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00241384
Enrollment
396
Registered
2005-10-18
Start date
2005-01-31
Completion date
2015-11-30
Last updated
2015-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Prostatic Cancer, Brachytherapy, Prostatic neoplasm, Radiation therapy

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.

Interventions

Sponsors

Theragenics
CollaboratorUNKNOWN
University of Washington
CollaboratorOTHER
Schiffler Cancer Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
40 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Serial PSA : 6, 12, 18 and 24 months and then yearly.6, 12, 18 and 24 months and then yearlySerial PSA : 6, 12, 18 and 24 months and then yearly.
Post treatment biopsies in those with persistently elevatedas neededPost treatment biopsies in those with persistently elevated
PSA which is suggestive of residual tumor.as neededPSA which is suggestive of residual tumor.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026