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A phase IIIb randomized study of intermittent versus continuous androgen deprivation therapy using ELIGARD 22.5 mg 3-month depot in subjects with relapsing or locally advanced prostate cancer who are ...

Update Il y a 5 ans
Reference: EUCTR2005-004094-25

A phase IIIb randomized study of intermittent versus continuous androgen deprivation therapy using ELIGARD 22.5 mg 3-month depot in subjects with relapsing or locally advanced prostate cancer who are responsive to such therapy

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Extract

To assess prostate-specific antigen (PSA) and testosterone levels after continuous and intermittent androgen deprivation therapy and compare time to PSA progression.

Inclusion criteria

  • Histologically or cytologically confirmed adenocarcinoma of the prostate (PCa) meeting the following criteria: - Locally adv. (stage T3 or T4) PCa, N0 or N+, M0 with PSA >= 5 ng/ml, or - Relapsing PCa following radical prostatectomy for clinically localized PCa with a serum PSA of >= 0.4 ng/ml or, - Relapsing PCa following radiotherapy with a serum PSA of >= 1 ng/ml as compared to a previous reference value

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