Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

May 3, 2005
August 6, 2013
October 2004
December 2009   (final data collection date for primary outcome measure)
Death from any cause at 8 years [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00110162 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Androgen Deprivation Therapy in Treating Patients With Prostate Cancer
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.

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.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Treatment
Prostate Cancer
  • Drug: antiandrogen therapy
  • Drug: releasing hormone agonist therapy
  • Procedure: orchiectomy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2000
Not Provided
December 2009   (final data collection date for primary outcome measure)

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
Male
Not Provided
No
Australia,   New Zealand
 
NCT00110162
PMCC-VCOG-PR-0103, CDR0000413706, PMCC-TROG-0306
Not Provided
Not Provided
Peter MacCallum Cancer Centre, Australia
Not Provided
Study Chair: Gillian M. Duchesne, MD, FRCR Peter MacCallum Cancer Centre, Australia
National Cancer Institute (NCI)
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP