NCT02175212

Clinical Trials of Adjuvant Androgen Deprivation in Localized Prostate Cancer

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 362 (actual)
• Sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Short term androgen deprivation	* Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months) * Bicalutamide 50 mg tablet every day for 2 months
DRUG	Long term androgen deprivation	* Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months) * Bicalutamide 50 mg tablet every day for 2 months * Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy
RADIATION	Short term androgen deprivation	Minimum dose of 76 Gy (range 76-82 Gy)
RADIATION	Long term androgen deprivation	Minimum dose of 76 Gy (range 76-82 Gy)

Timeline

• Start date: 2005-11-01
• Primary completion: 2014-06-01
• Completion: 2020-09-24
• First posted: 2014-06-26
• Last updated: 2020-11-20
• Results posted: 2016-11-04

Locations

1 site across 1 country: Spain