Radiotherapy vs Observation for CRPC

Zhengzhou University

Status: Unknown

Conditions: Hormone Refractory Prostate Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT01590498

PCA0608

NNSFC (Other Grant/Funding Number)

Details and patient eligibility

About

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

Enrollment: 2,000 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

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.

Trial design

2,000 participants in 2 patient groups

Salvage radiotherapy

Description:

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

observation

Description:

did not receive salvage following biochemical or clinical recurrence