Clinical Trials of Adjuvant Androgen Deprivation in Localized Prostate Cancer
This trial is active, not recruiting.
|Treatments||goserelina 4 months and bicalutamida, goserelina|
|Sponsor||Hospital Universitario de la Princesa|
|Start date||November 2005|
|End date||June 2014|
|Trial size||358 participants|
|Trial identifier||NCT02175212, DART01/05|
The present study is a phase III randomized and multicentric trial evaluating the potential additional impact effect of two years adjuvant androgen deprivation when combined with neoadjuvant (4 months) and high-dose (76 Gy) conformal radiotherapy in moderate high-risk prostate cancer patients. Stratification will be performed by prognostic factors and by participating institution.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Biochemical relapse was defined as the time from inclusion in the study (randomization) until the patient meets criteria for Biochemistry (Phoenix criteria: PSA nadir plus 2 ng/ml).
time frame: 5 years
Metastasis free survival.
time frame: 3 and 5 years
Male participants at least 19 years old.
Inclusion Criteria: - Histological proven adenocarcinoma of the prostate - Estage: cT1b-3cN0M0 according to AJCC TNM - PSA<100 ng/ml - Intermediate (T1-T2 with GS 7 and/or PSA 10-20) - High risk (T3 and/or GS 8-10 and/or PSA > 20) - KI performance status ≥70% - Written informed consent Exclusion Criteria: - T4 N1 M1, - Previous surgical treatment (prostatectomy or cryosurgery) - Neoayuvant hormonal treatment > 3 months. - History of pelvic RT - Contraindications for radiotherapy - Concomitant use of chemotherapy - Serious psychiatric or medical condition - Current synchronic malignancies
|Official title||Phase III Multicenter Randomized Trial of Adjuvant Androgen Deprivation in Combination With Three-dimensional Conformal Radiotherapy Doses in High and Intermediate Risk Localized Prostate Cancer.|
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