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OpenTrials
Completed

NCT Number: NCT00241384

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Veterans Administration Puget Sound Health Care System, Seattle, Washington, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

External beam radiation

Procedure

Pd-103

Procedure

Primary outcomes

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

    Time frame: 6, 12, 18 and 24 months and then yearly

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

  2. Post treatment biopsies in those with persistently elevated

    Time frame: as needed

    Post treatment biopsies in those with persistently elevated

  3. PSA which is suggestive of residual tumor.

    Time frame: as needed

    PSA which is suggestive of residual tumor.

Sponsors and collaborators

Lead sponsor

Schiffler Cancer Center

Other

Collaborators

  • Theragenics
  • University of Washington

Registry information

Important dates

Study start
2005
Primary completion
2015
Study completion
2015
First posted
Oct 18, 2005
Registry last updated
Nov 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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