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Androgen Deprivation Therapy in Treating Patients With Prostate Cancer

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: NCT00110162
Recruitment Status : Unknown
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : May 4, 2005
Last Update Posted : August 7, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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 or disease Intervention/treatment Phase
Prostate Cancer Drug: antiandrogen therapy Drug: releasing hormone agonist therapy Procedure: orchiectomy Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
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
Study Start Date : October 2004
Estimated Primary Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer




Primary Outcome Measures :
  1. Death from any cause at 8 years

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


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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

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): NCT00110162


Locations
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Sponsors and Collaborators
Peter MacCallum Cancer Centre, Australia
Investigators
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Study Chair: Gillian M. Duchesne, MD, FRCR Peter MacCallum Cancer Centre, Australia
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00110162    
Other Study ID Numbers: PMCC-VCOG-PR-0103
CDR0000413706 ( Registry Identifier: PDQ (Physician Data Query) )
PMCC-TROG-0306
First Posted: May 4, 2005    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: June 2009
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:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Hormones
Androgen Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Hormone Antagonists