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NCT00110162 · CITED IN SOURCE DOCUMENTS

Androgen Deprivation Therapy in Treating Patients With Prostate Cancer

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
UNKNOWN
Registry last update
2013-08-07

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility 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
healthy Volunteers
false
sex
MALE
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
interventions
  1. name
    antiandrogen therapy
    type
    DRUG
  2. name
    releasing hormone agonist therapy
    type
    DRUG
  3. name
    orchiectomy
    type
    PROCEDURE
Study design
allocation
RANDOMIZED
primary Purpose
TREATMENT
Enrollment
count
2000
type
ESTIMATED
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Death from any cause at 8 years
secondary Outcomes
  1. measure
    Cancer specific survival
  2. measure
    Clinical progression
  3. measure
    Time to first androgen independence
  4. measure
    Complication rate incidence and timing (e.g., cord compression, pathological fracture)
  5. measure
    Treatment-related morbidity (including cognitive, osteoporosis)
  6. measure
    Prognostic factors for progression (delayed group)
  7. measure
    EORTC Quality of life - general QLQC30 and prostate module for Quality of life annually for 5 years
  8. measure
    CTC v3.0 Survival endpoints: actuarial analysis at eight years
  9. measure
    Morbidity continuously
Full study description
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.
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.
Source references
references
  1. citation
    Duchesne GM, Woo HH, King M, Bowe SJ, Stockler MR, Ames A, D'Este C, Frydenberg M, Loblaw A, Malone S, Millar J, Tai KH, Turner S. Health-related quality of life for immediate versus delayed androgen-deprivation therapy in patients with asymptomatic, non-curable prostate cancer (TROG 03.06 and VCOG PR 01-03 [TOAD]): a randomised, multicentre, non-blinded, phase 3 trial. Lancet Oncol. 2017 Sep;18(9):1192-1201. doi: 10.1016/S1470-2045(17)30426-6. Epub 2017 Jul 28.
    pmid
    28760403
    type
    DERIVED
  2. citation
    Duchesne GM, Woo HH, Bassett JK, Bowe SJ, D'Este C, Frydenberg M, King M, Ledwich L, Loblaw A, Malone S, Millar J, Milne R, Smith RG, Spry N, Stockler M, Syme RA, Tai KH, Turner S. Timing of androgen-deprivation therapy in patients with prostate cancer with a rising PSA (TROG 03.06 and VCOG PR 01-03 [TOAD]): a randomised, multicentre, non-blinded, phase 3 trial. Lancet Oncol. 2016 Jun;17(6):727-737. doi: 10.1016/S1470-2045(16)00107-8. Epub 2016 May 4.
    pmid
    27155740
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        nts treated with radiation therapy.[<a href="#cit/section_8.14">14</a>,<a href="#cit/section_8.15">15</a>]</li><li>A randomized trial (<a href="/clinicaltrials/NCT00110162">PMCC-VCOG-PR-0103</a> [NCT00110162]) of androgen deprivation therapy (ADT) in men who received curative therapy but had a rising PSA, provided some evidence o
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        <a href="#cit/section_8.14">14</a>,<a href="#cit/section_8.15">15</a>]</li><li>A randomized trial (<a href="/clinicaltrials/NCT00110162">PMCC-VCOG-PR-0103</a> [NCT00110162]) of androgen deprivation therapy (ADT) in men who received curative therapy but had a rising PSA, provided some evidence of improved OS associated with immedi
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      source retrieved at
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      source title
      Prostate Cancer Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: May 14, 2025
        datetime
        2025-05-14T12:00:00Z
        display
        May 14, 2025

    Preserved source evidence · Not medical advice