Androgen Deprivation Therapy in Treating Patients With Prostate Cancer

August 6, 2013 updated by: Peter MacCallum Cancer Centre, Australia

A Collaborative Randomized Phase III Trial: The Timing of Intervention With Androgen Deprivation in Prostate Cancer Patients With Rising PSA

RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy may stop the adrenal glands from making androgens.

PURPOSE: This randomized phase III trial is studying how well androgen deprivation therapy works in treating patients with prostate cancer.

Study Overview

Detailed Description

OBJECTIVES:

Primary

  • Compare overall survival (with acceptable morbidity) of patients with prostate cancer treated with delayed vs immediate androgen deprivation therapy (ADT).

Secondary

  • Compare cancer-specific survival of patients treated with these regimens.
  • Compare clinical progression in patients treated with these regimens.
  • Compare time to first androgen independence in patients treated with these regimens.
  • Compare complication rate incidence and timing (e.g., cord compression or pathological failure) in patients treated with these regimens.
  • Compare treatment-related morbidity (including cognitive morbidity or osteoporosis) in patients treated with these regimens.
  • Compare quality of life of patients treated with these regimens.
  • Determine prognostic factors for progression in patients treated with delayed ADT.

OUTLINE: This is a multicenter, randomized, controlled study. Patients in group 1 are stratified according to prior therapy (prostatectomy vs radiotherapy vs prostatectomy and radiotherapy), relapse-free interval (< 2 years vs ≥ 2 years), type of planned androgen deprivation therapy (ADT) (continuous vs intermittent), and participating center. Patients in group 2 are stratified according to type of planned ADT (continuous vs intermittent), disease type (localized vs metastatic), and participating center. Patients in both groups are randomized to 1 of 2 treatment arms.

  • Arm I (delayed ADT): Beginning at least 2 years after study entry or after exhibiting evidence of significant disease progression*, patients receive either continuous ADT OR intermittent ADT comprising either bilateral orchiectomy OR luteinizing hormone-releasing hormone agonist with or without oral antiandrogen therapy.
  • Arm II (immediate ADT): Beginning immediately after randomization, patients receive either continuous ADT OR intermittent ADT as in arm I.

NOTE: *Patients in group 1 begin delayed ADT at least 2 years after study entry unless 1 of the following clinical criteria is present: prostate-specific antigen (PSA) doubling time of < 12 months with PSA ≥ 10 ng/mL OR PSA doubling time of ≤ 6 months based on 3 consecutive measurements obtained ≥ 2 months apart OR development of metastases or symptoms. Patients in group 2 begin delayed ADT at least 2 years after study entry unless 1 of the following clinical criteria is present: development of symptoms OR PSA ≥ 60 ng/mL OR PSA doubling time of ≤ 6 months based on 3 consecutive measurements obtained ≥ 2 months apart.

After 9 months of ADT, all patients are assessed for response. Patients with PSA < 4 ng/mL may discontinue ADT. These patients are followed every 3 months. Treatment may be restarted when PSA is > 20 ng/mL OR PSA is > the PSA level at study entry OR at clinical progression.

Quality of life is assessed at baseline, every 6 months for 2 years, and then annually for 3 years.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then periodically thereafter at the discretion of the principal investigator.

PROJECTED ACCRUAL: A total of 300-2,000 patients will be accrued for this study within 2-5 years.

Study Type

Interventional

Enrollment (Anticipated)

2000

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

      • Christchurch, Australia, 1
        • Recruiting
        • Christchurch Hospital
        • Contact:
          • Chris Atkinson
          • Phone Number: 64-3-364-0020
    • New South Wales
      • Campbelltown, New South Wales, Australia, 2560
        • Recruiting
        • Cancer Therapy Centre at Campbelltown Hospital
        • Contact:
      • Concord, New South Wales, Australia, 2139
        • Recruiting
        • Concord Repatriation General Hospital
        • Contact:
          • George Hruby, MD
          • Phone Number: 61-2-9767-5112
      • Kingswood, New South Wales, Australia, 2747
        • Recruiting
        • Nepean Cancer Care Centre at Nepean Hospital
        • Contact:
          • Viet Do
          • Phone Number: 61-2-4734-3500
      • Liverpool, New South Wales, Australia, 2170
        • Recruiting
        • Cancer Therapy Centre at Liverpool Hospital
        • Contact:
      • Sydney, New South Wales, Australia, 2050
        • Recruiting
        • Sydney Cancer Centre at Royal Prince Alfred Hospital
        • Contact:
      • Westmead, New South Wales, Australia, 2145
        • Recruiting
        • Westmead Institute for Cancer Research at Westmead Hospital
        • Contact:
          • Sandra Turner
          • Phone Number: 61-2-9845-6499
    • Queensland
      • Brisbane, Queensland, Australia, 4102
        • Recruiting
        • Princess Alexandra Hospital
        • Contact:
          • Margot Lehman
          • Phone Number: 61-7-3240-6799
      • Brisbane, Queensland, Australia, 4029
        • Recruiting
        • Royal Brisbane and Women's Hospital
        • Contact:
      • South Brisbane, Queensland, Australia, 4101
      • Tugun, Queensland, Australia, 4224
        • Recruiting
        • East Coast Cancer Centre
        • Contact:
          • David Christie, MD
          • Phone Number: 61-7-5598-0366
    • South Australia
      • Ashford, South Australia, Australia, 5035
        • Recruiting
        • Urological Solutions
        • Contact:
          • Graham Sinclair, MD
          • Phone Number: 61-8-8297-3877
      • Daws Park, South Australia, Australia, 5041
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Recruiting
        • Peter MacCallum Cancer Centre
        • Contact:
      • Geelong, Victoria, Australia, 3200
        • Recruiting
        • Geelong Hospital
        • Contact:
          • Michael Francis, MBBS, FRACR
          • Phone Number: 6-13-5226-7644
      • Melbourne, Victoria, Australia, 3004
      • Warragul, Victoria, Australia, 3820
        • Recruiting
        • West Gippsland Hospital
        • Contact:
          • William Straffon, MD
          • Phone Number: 61-3-5623-0857
      • Dunedin, New Zealand
      • Hamilton, New Zealand, 2020
        • Recruiting
        • Waikato Hospital
        • Contact:
          • Leanne Tyrie
          • Phone Number: 64-7-839-8976
      • Palmerston North, New Zealand
        • Recruiting
        • Palmerston North Hospital
        • Contact:
          • Johan S. Nel, MD
          • Phone Number: 64-6-350-8430

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate
  • Prostate-specific antigen (PSA) relapse OR incurable disease diagnosed within the past 2 months AND meets criteria for either of the following groups:

    • Group 1

      • In PSA relapse after definitive radical treatment (prostatectomy or radiotherapy), as evidenced by 1 the following:

        • Post-prostatectomy PSA level ≥ 0.2 ng/mL
        • At least 3 rising PSA levels (post-radiotherapy) obtained ≥ 1 month apart, with the last PSA obtained within the past 2 months
      • No metastatic disease by bone scan or abdomino-pelvic CT scan
    • Group 2

      • Not suitable for radical treatment at primary diagnosis
      • Not planning to receive curative treatment
      • Localized or metastatic disease

        • No symptomatic disease requiring radiotherapy or immediate hormonal therapy
  • No symptomatic disease requiring therapy

PATIENT CHARACTERISTICS:

Age

  • Any age

Performance status

  • Not specified

Life expectancy

  • At least 5 years

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • No other significant comorbid condition that would limit life expectancy to < 5 years

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • At least 12 months since prior androgen deprivation therapy (ADT) administered in the neoadjuvant or concurrent (with radiotherapy) setting (group 1)
  • No prior ADT (group 2)

Radiotherapy

  • See Disease Characteristics
  • See Endocrine therapy

Surgery

  • See Disease Characteristics

Other

  • No concurrent enrollment in TROG-96.01 or TROG-RADAR protocols

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Death from any cause at 8 years

Secondary Outcome Measures

Outcome Measure
Cancer specific survival
Clinical progression
Time to first androgen independence
Complication rate incidence and timing (e.g., cord compression, pathological fracture)
Treatment-related morbidity (including cognitive, osteoporosis)
Prognostic factors for progression (delayed group)
EORTC Quality of life - general QLQC30 and prostate module for Quality of life annually for 5 years
CTC v3.0 Survival endpoints: actuarial analysis at eight years
Morbidity continuously

Collaborators and Investigators

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

Investigators

  • Study Chair: Gillian M. Duchesne, MD, FRCR, Peter MacCallum Cancer Centre, Australia

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.

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

October 1, 2004

Primary Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

May 3, 2005

First Submitted That Met QC Criteria

May 3, 2005

First Posted (Estimate)

May 4, 2005

Study Record Updates

Last Update Posted (Estimate)

August 7, 2013

Last Update Submitted That Met QC Criteria

August 6, 2013

Last Verified

June 1, 2009

More Information

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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