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Clinical Trials of Adjuvant Androgen Deprivation in Localized Prostate Cancer

NCT02175212 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 362

Last updated 2020-11-20

Study results available
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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

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)

Sponsors & Collaborators

  • Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

    lead OTHER

Principal Investigators

  • Almudena Zapatero, MD PhD, IP · Grupo de Investigación Clínica en Oncología Radioterapia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2014-06-30
Completion
2020-09-24

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02175212 on ClinicalTrials.gov