Overview

This trial is active, not recruiting.

Condition prostate adenocarcinoma
Treatments goserelina 4 months and bicalutamida, goserelina
Phase phase 3
Sponsor Hospital Universitario de la Princesa
Start date November 2005
End date June 2014
Trial size 358 participants
Trial identifier NCT02175212, DART01/05

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Goserelina 10,8 mg by subcutaneous injection for 4 moths Goserelina 10,8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy
goserelina
Goserelina 10,8 mg by subcutaneous injection for 4 months Goserelina 10,8 mg by subcutaneous injection every 3 months for 2 years at the end of the radiotherapy.
(Active Comparator)
Goserelina10,8 mg by subcutaneous injection for 4 moths Bicalutamida 50 mg tablet every day for 2 months
goserelina 4 months and bicalutamida
Goserelina 10,8 mg by subcutaneous injection for 4 months Bicalutamida 50 mg tablet every day for 2 months

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Metastasis free survival.
time frame: 3 and 5 years

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by Hospital Universitario de la Princesa.