Clinical Trials of Adjuvant Androgen Deprivation in Localized Prostate Cancer (AADLPC)

November 3, 2020 updated by: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

362

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28006
        • Hospital Universitario de la Princesa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
  • High dose conformal radiotherapy
  • Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy
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
Other Names:
  • Neoadjuvant, concomitant and adjuvant
Radiation: Long term androgen deprivation
Minimum dose of 76 Gy (range 76-82 Gy)
Active Comparator: 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
  • High dose conformal radiotherapy
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
Other Names:
  • Neoadjuvant and concomitant
Radiation: Short term androgen deprivation
Minimum dose of 76 Gy (range 76-82 Gy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical Disease Free Survival: Estimated Percentage of Participants With Biochemical Disease-free Survival at 5 Years
Time Frame: 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).
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metastasis Free Survival: Estimated Percentage of Participants With Metastasis-free Survival at 5 Years
Time Frame: 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).
5 years
Overall Survival: Estimated Percentage of Participants Alive at 5 Years
Time Frame: 5 years
Overall Survival: defined as the time that elapses from the patient enters the study until the patient dies from any cause.
5 years
Cause-specific Survival
Time Frame: 5 years
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
5 years
Late Toxicity
Time Frame: 5 years

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
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Investigators

  • Principal Investigator: Almudena Zapatero, MD PhD, IP, Grupo de Investigación Clínica en Oncología Radioterapia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

September 24, 2020

Study Registration Dates

First Submitted

June 23, 2014

First Submitted That Met QC Criteria

June 25, 2014

First Posted (Estimate)

June 26, 2014

Study Record Updates

Last Update Posted (Actual)

November 20, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DART01/05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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