Androgen Deprivation Therapy in Treating Patients With Prostate Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00110162
First received: May 3, 2005
Last updated: August 6, 2013
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: antiandrogen therapy
Drug: releasing hormone agonist therapy
Procedure: orchiectomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Collaborative Randomized Phase III Trial: The Timing of Intervention With Androgen Deprivation in Prostate Cancer Patients With Rising PSA

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Death from any cause at 8 years [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cancer specific survival [ Designated as safety issue: No ]
  • Clinical progression [ Designated as safety issue: No ]
  • Time to first androgen independence [ Designated as safety issue: No ]
  • Complication rate incidence and timing (e.g., cord compression, pathological fracture) [ Designated as safety issue: No ]
  • Treatment-related morbidity (including cognitive, osteoporosis) [ Designated as safety issue: No ]
  • Prognostic factors for progression (delayed group) [ Designated as safety issue: No ]
  • EORTC Quality of life - general QLQC30 and prostate module for Quality of life annually for 5 years [ Designated as safety issue: No ]
  • CTC v3.0 Survival endpoints: actuarial analysis at eight years [ Designated as safety issue: No ]
  • Morbidity continuously [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: October 2004
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110162

Locations
Australia, New South Wales
Cancer Therapy Centre at Campbelltown Hospital Recruiting
Campbelltown, New South Wales, Australia, 2560
Contact: Martin P. Berry    61-2-4636-4375    martin.berry@swsahs.nsw.gov.au   
Concord Repatriation General Hospital Recruiting
Concord, New South Wales, Australia, 2139
Contact: George Hruby, MD    61-2-9767-5112      
Nepean Cancer Care Centre at Nepean Hospital Recruiting
Kingswood, New South Wales, Australia, 2747
Contact: Viet Do    61-2-4734-3500      
Cancer Therapy Centre at Liverpool Hospital Recruiting
Liverpool, New South Wales, Australia, 2170
Contact: Andrew Kneebone    6-12-9828-5282    andrew.kneebone@swsahs.gov.au   
Sydney Cancer Centre at Royal Prince Alfred Hospital Recruiting
Sydney, New South Wales, Australia, 2050
Contact: George Hruby, MD    61-2-9515-8057    ghruby@email.cs.nsw.gov.au   
Westmead Institute for Cancer Research at Westmead Hospital Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Sandra Turner    61-2-9845-6499      
Australia, Queensland
Royal Brisbane and Women's Hospital Recruiting
Brisbane, Queensland, Australia, 4029
Contact: Lizbeth Kenny, MD    61-7-3636-8111    lizkenny@bigpond.net.au   
Princess Alexandra Hospital Recruiting
Brisbane, Queensland, Australia, 4102
Contact: Margot Lehman    61-7-3240-6799      
Mater Adult Hospital Recruiting
South Brisbane, Queensland, Australia, 4101
Contact: Guy Bryant    6-17-3840-3255    guy-bryant@health.qld.gov.au   
East Coast Cancer Centre Recruiting
Tugun, Queensland, Australia, 4224
Contact: David Christie, MD    61-7-5598-0366      
Australia, South Australia
Urological Solutions Recruiting
Ashford, South Australia, Australia, 5035
Contact: Graham Sinclair, MD    61-8-8297-3877      
Repatriation General Hospital Recruiting
Daws Park, South Australia, Australia, 5041
Contact: Alan Stapleton    61-8-8275-1927    alan.stapleton@rgh.sa.gov.au   
Australia, Victoria
Peter MacCallum Cancer Centre Recruiting
East Melbourne, Victoria, Australia, 3002
Contact: Gillian M. Duchesne, MD, FRCR    61-3-9656-1004    gillian.duchesne@petermac.org   
Geelong Hospital Recruiting
Geelong, Victoria, Australia, 3200
Contact: Michael Francis, MBBS, FRACR    6-13-5226-7644      
Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Jeremy Millar    61-3-9276-2337    jeremy.millar@med.monash.edu.au   
West Gippsland Hospital Recruiting
Warragul, Victoria, Australia, 3820
Contact: William Straffon, MD    61-3-5623-0857      
Australia
Christchurch Hospital Recruiting
Christchurch, Australia, 1
Contact: Chris Atkinson    64-3-364-0020      
New Zealand
Dunedin Hospital Recruiting
Dunedin, New Zealand
Contact: John North    64-3-474-7947    johnn@healthotago.co.nz   
Waikato Hospital Recruiting
Hamilton, New Zealand, 2020
Contact: Leanne Tyrie    64-7-839-8976      
Palmerston North Hospital Recruiting
Palmerston North, New Zealand
Contact: Johan S. Nel, MD    64-6-350-8430      
Sponsors and Collaborators
Peter MacCallum Cancer Centre, Australia
Investigators
Study Chair: Gillian M. Duchesne, MD, FRCR Peter MacCallum Cancer Centre, Australia
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00110162     History of Changes
Other Study ID Numbers: PMCC-VCOG-PR-0103, CDR0000413706, PMCC-TROG-0306
Study First Received: May 3, 2005
Last Updated: August 6, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Androgen Antagonists
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Hormone Antagonists

ClinicalTrials.gov processed this record on September 18, 2014