CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 362 enrolled
Drug / intervention
Short term androgen deprivation +3 moredrug
Likely dose
Short term androgen deprivation 3.6 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02175212
NCT02175212Phase 3Completed
CompareCT.gov

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.

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa·interventional·Posted Jun 26, 2014·Updated Nov 20, 2020

In Brief

A Phase 3 clinical trial evaluating Short term androgen deprivation and Long term androgen deprivation for Prostate Adenocarcinoma. Completed, enrolled 362 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Adenocarcinoma
CountriesSpain
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 26, 2014
Enrollment StartNov 1, 2005
Primary CompletionJun 1, 2014
Study CompletionSep 24, 2020
TodayJul 2, 2026
Enrollment to primary: 8.6 yearsPosted 12.0 years ago

Interventions

Short term androgen deprivationdrug

* 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

Long term androgen deprivationdrug

* 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

Short term androgen deprivationradiation

Minimum dose of 76 Gy (range 76-82 Gy)

Long term androgen deprivationradiation

Minimum dose of 76 Gy (range 76-82 Gy)