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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: External beam radiation
* Procedure: Pd-103


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pd-103 with 20Gy External Beam<br>Pd-103 with 20Gy External Beam | Procedure: External beam radiation<br> <br> |
| Active Comparator: Pd-103 alone<br>Pd-103 alone | Procedure: Pd-103<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serial PSA : 6, 12, 18 and 24 months and then yearly. | Serial PSA : 6, 12, 18 and 24 months and then yearly. | 6, 12, 18 and 24 months and then yearly | 
| Post treatment biopsies in those with persistently elevated | Post treatment biopsies in those with persistently elevated | as needed | 
| PSA which is suggestive of residual tumor. | PSA which is suggestive of residual tumor. | as needed | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostatic Cancer, Brachytherapy, Prostatic neoplasm, Radiation therapy