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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02175212
Recruitment Status : Completed
First Posted : June 26, 2014
Results First Posted : November 4, 2016
Last Update Posted : November 20, 2020
Sponsor:
Information provided by (Responsible Party):
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Prostate Adenocarcinoma Drug: Short term androgen deprivation Drug: Long term androgen deprivation Radiation: Short term androgen deprivation Radiation: Long term androgen deprivation Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 362 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : November 2005
Actual Primary Completion Date : June 2014
Actual Study Completion Date : September 24, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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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 Name: 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 Name: Neoadjuvant and concomitant

Radiation: Short term androgen deprivation
Minimum dose of 76 Gy (range 76-82 Gy)


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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

  4. 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



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02175212


Locations
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Spain
Hospital Universitario de la Princesa
Madrid, Spain, 28006
Sponsors and Collaborators
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Investigators
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Principal Investigator: Almudena Zapatero, MD PhD, IP Grupo de Investigación Clínica en Oncología Radioterapia
More Information
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Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
ClinicalTrials.gov Identifier: NCT02175212    
Other Study ID Numbers: DART01/05
First Posted: June 26, 2014    Key Record Dates
Results First Posted: November 4, 2016
Last Update Posted: November 20, 2020
Last Verified: November 2020
Keywords provided by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa:
Patients with prostate adenocarcinoma
Additional relevant MeSH terms:
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Adenocarcinoma
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Ascorbic Acid
Methyltestosterone
Androgens
Estrogens, Conjugated (USP)
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
 Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Vitamins
Micronutrients
Estrogens
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents