Clinical Trials of Adjuvant Androgen Deprivation in Localized Prostate Cancer

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa362 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

362

Conditions

Prostate Adenocarcinoma

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)

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histological proven adenocarcinoma of the prostate * Stage: cT1c-3b N0M0 according to American Joint Committee on Cancer (AJCC) Tumor Node Metastasis (TNM) * Prostatic Specific Antigen (PSA)\<100 ng/ml * Intermediate (T1-T2 with Gleason Score \[GS\] 7 and/or PSA 10-20) * High risk (T3 and/or GS 8-10 and/or PSA \> 20) * Karnofsky Index (KI) performance status ≥70% * Written informed consent Exclusion Criteria: * T4 N1 M1, * Previous surgical treatment (prostatectomy or cryosurgery) * Neoadjuvant hormonal treatment \> 3 months. * History of pelvic radiotherapy (RT) * Contraindications for radiotherapy * Concomitant use of chemotherapy * Serious psychiatric or medical condition * Current synchronic malignancies

Locations (1)

Hospital Universitario de la Princesa

Madrid, Spain

Outcomes

Primary Outcomes

Biochemical Disease Free Survival: Estimated Percentage of Participants With Biochemical Disease-free Survival at 5 Years

Biochemical relapse was defined as the time from inclusion in the study (randomization) until the patient meets criteria for Biochemical failure (Phoenix criteria: PSA nadir plus 2 ng/ml).

Time frame: 5 years

Secondary Outcomes

Metastasis Free Survival: Estimated Percentage of Participants With Metastasis-free Survival at 5 Years

Metastasis free survival: defined as the time from inclusion in the study (randomization) until the appearance of distant metastases: a positive result in any of the tests performed (scintigraphy, chest radiography, thorax, abdominal and pelvic CT and MRI).

Time frame: 5 years

Overall Survival: Estimated Percentage of Participants Alive at 5 Years

Overall Survival: defined as the time that elapses from the patient enters the study until the patient dies from any cause.

Time frame: 5 years

Cause-specific Survival

Cause-specific survival included all deaths from prostate cancer or treatment complications, and deaths from unknown causes in patients with either active cancer or a previously documented relapse

Time frame: 5 years

Late Toxicity

Defined as the maximal rectal, urinary and cardiovascular (CV) toxicity per patient more than 90 days after completion of RT. Scoring scales used were the radiation morbidity scoring criteria of the European Organization for Research and Treatment of Cancer-Radiation Therapy Oncology Group (EORTC/RTOG) and the Common Terminology Criteria for Adverse Events (CTCAEs) v 3.0 for the remained toxicity. CV events were defined according to the World Health Organization criteria

Time frame: 5 years

Data from ClinicalTrials.gov

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