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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

568 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-01-31

Study Completion Date

2007-06-30

Brief Summary

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Objective: The objective of this study is test the hypothesis that delivering a higher percentage of the radiation dose as external radiation versus implant will lead to higher tumor control rates.

Research design A total of 600 patients with AJC clinical stage T1-T2 prostatic carcinoma (Gleason grade 7 to 10 and/or PSA 10 to 20 ng/ml) will be randomized to treatment with 44 Gy versus 20 Gy external radiation plus a Pd-103 implant boost (90 Gy versus 105 Gy, respectively).

Detailed Description

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Objective: The objective of this study is test the hypothesis that delivering a higher percentage of the radiation dose as external radiation versus implant will lead to higher tumor control rates.

Research design A total of 600 patients with AJC clinical stage T1-T2 prostatic carcinoma (Gleason grade 7 to 10 and/or PSA 10 to 20 ng/ml) will be randomized to treatment with 44 Gy versus 20 Gy external radiation plus a Pd-103 implant boost (90 Gy versus 105 Gy, respectively).

Methodology: Patients will be randomized by the method of random permuted blocks.

Cancer status will be monitored by serial serum PSA at 6, 12, 18 and 24 months and yearly thereafter. Treatment-related morbidity will be monitored by personal interview, using standard American Urologic Association and Radiation Therapy Oncology Group criteria at 1, 3, 6, 12 and 24 months. The primary endpoint will be based on serum PSA. A value above 1.0 ng/ml two years after treatment will be considered to have residual or recurrent cancer and to have failed therapy.

Findings: 566 patients have been randomized and the study was closed due to slowing accrual. A preliminary analysis shows similar morbidity between the treatment arms, and nearly identical cancer control rates between randomization arms.

Conditions

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Prostate Cancer

Keywords

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prostate brachytherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Pd-103 with 20 vs 44 Gy supplemental beam XRT

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Males
* Prostate cancer
* PSA 10-20
* Gleason score 7-10

Exclusion Criteria

* Lymph nodes positive

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Principal Investigators

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Kent E Wallner, MD

Role: STUDY_CHAIR

Puget Sound Health Care system

Locations

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VA Puget Sound

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Wallner K, Merrick G, True L, Sherertz T, Sutlief S, Cavanagh W, Butler W. 20 Gy versus 44 Gy supplemental beam radiation with Pd-103 prostate brachytherapy: preliminary biochemical outcomes from a prospective randomized multi-center trial. Radiother Oncol. 2005 Jun;75(3):307-10. doi: 10.1016/j.radonc.2005.03.019.

Reference Type RESULT

PMID: 16086912 (View on PubMed)

Other Identifiers

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2044

Identifier Type: -

Identifier Source: org_study_id