Radiotherapy vs Observation for CRPC

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

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2017-03-31

Brief Summary

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The purpose of the study is to determine whether radiotherapy improves cancer control and overall survival among patients with Castration resistant prostate cancer.

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Detailed Description

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Conditions

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Hormone Refractory Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Salvage radiotherapy

local radiation to the prostate and metastasis following biochemical or clinical recurrence

No interventions assigned to this group

observation

did not receive salvage following biochemical or clinical recurrence

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Eligible patients had histologically or cytologically confirmed adenocarcinoma of the prostate with clinical or radiologic evidence of disease progression during hormonal therapy
2. Patients were receiving primary androgen-ablation therapy as maintenance therapy. At least four weeks had to have elapsed between the withdrawal of antiandrogens (six weeks in the case of bicalutamide) and enroll ment, so as to avoid the possibility of confounding as a result of the response to antiandrogen withdrawal.
3. Another requirement was disease progression, as indicated by increasing serum levels of PSA on three consecutive measurements obtained at least one week apart or findings on physical examination or imaging studies.
4. Normal cardiac function was required.

Exclusion Criteria

1. patients had a Karnofsky performance-status score of at most 60 percent
2. prior treatment with cytotoxic agents or radioisotopes
3. with history of another cancer within the preceding five years, brain or leptomeningeal metastases, symptomatic peripheral neuropathy of grade 2 or higher, and other serious medical condition.

Eligible Sex

MALE

Accepts Healthy Volunteers

No