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

Primary Purpose

Prostate Adenocarcinoma

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Short term androgen deprivation
Long term androgen deprivation
Short term androgen deprivation
Long term androgen deprivation
Sponsored by
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Adenocarcinoma focused on measuring Patients with prostate adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitario de la Princesa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Long term androgen deprivation

Short term androgen deprivation

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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.
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
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

Full Information

First Posted
June 23, 2014
Last Updated
November 3, 2020
Sponsor
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
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1. Study Identification

Unique Protocol Identification Number
NCT02175212
Brief Title
Clinical Trials of Adjuvant Androgen Deprivation in Localized Prostate Cancer
Acronym
AADLPC
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 Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
September 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Adenocarcinoma
Keywords
Patients with prostate adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
362 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Long term androgen deprivation
Arm Type
Experimental
Arm Description
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
Arm Title
Short term androgen deprivation
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Short term androgen deprivation
Other Intervention Name(s)
Neoadjuvant and concomitant
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Long term androgen deprivation
Other Intervention Name(s)
Neoadjuvant, concomitant and adjuvant
Intervention Description
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
Intervention Type
Radiation
Intervention Name(s)
Short term androgen deprivation
Intervention Description
Minimum dose of 76 Gy (range 76-82 Gy)
Intervention Type
Radiation
Intervention Name(s)
Long term androgen deprivation
Intervention Description
Minimum dose of 76 Gy (range 76-82 Gy)
Primary Outcome Measure Information:
Title
Biochemical Disease Free Survival: Estimated Percentage of Participants With Biochemical Disease-free Survival at 5 Years
Description
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 Outcome Measure Information:
Title
Metastasis Free Survival: Estimated Percentage of Participants With Metastasis-free Survival at 5 Years
Description
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
Title
Overall Survival: Estimated Percentage of Participants Alive at 5 Years
Description
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
Title
Cause-specific Survival
Description
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
Title
Late Toxicity
Description
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Almudena Zapatero, MD PhD, IP
Organizational Affiliation
Grupo de Investigación Clínica en Oncología Radioterapia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario de la Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain

12. IPD Sharing Statement

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Clinical Trials of Adjuvant Androgen Deprivation in Localized Prostate Cancer

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