Androgen Deprivation Therapy in Treating Patients With Prostate Cancer

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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

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by:

National Cancer Institute (NCI)

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.

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

Show detailed description

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 Design

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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 Genetics related topics: Prostate cancer

MedlinePlus related topics: Prostate Cancer

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

Death from any cause at 8 years

Secondary Outcome Measures :

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

Eligibility Criteria

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

Contacts and Locations

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

Show 20 study locations

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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

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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. Erratum In: Lancet Oncol. 2016 Jun;17 (6):e223. Lancet Oncol. 2017 Sep;18(9):e510.

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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 Genital Diseases, Male Genital Diseases Urogenital Diseases	Prostatic Diseases Male Urogenital Diseases Hormones Androgen Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Hormone Antagonists

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