Androgen Deprivation Therapy in Treating Patients With Prostate Cancer

NCT00110162 | Unknown Phase 3

• 3 other identifiers: PMCC-VCOG-PR-0103CDR0000413706PMCC-TROG-0306
• Study Type: interventional
• Target: 2,000
• Locations: 2 countries
• Sites: 20

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.

Conditions

Prostate Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Death from any cause at 8 years

Secondary Outcomes (9)

• 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)

Interventions

antiandrogen therapy DRUG

releasing hormone agonist therapy DRUG

orchiectomy PROCEDURE

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Peter MacCallum Cancer Centre, Australia: lead

Study Sites (20)

Cancer Therapy Centre at Campbelltown Hospital

Campbelltown, New South Wales, 2560, Australia

RECRUITING

Concord Repatriation General Hospital

Concord, New South Wales, 2139, Australia

RECRUITING

Nepean Cancer Care Centre at Nepean Hospital

Kingswood, New South Wales, 2747, Australia

RECRUITING

Cancer Therapy Centre at Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

RECRUITING

Sydney Cancer Centre at Royal Prince Alfred Hospital

Sydney, New South Wales, 2050, Australia

RECRUITING

Westmead Institute for Cancer Research at Westmead Hospital

Westmead, New South Wales, 2145, Australia

RECRUITING

Royal Brisbane and Women's Hospital

Brisbane, Queensland, 4029, Australia

RECRUITING

Princess Alexandra Hospital

Brisbane, Queensland, 4102, Australia

RECRUITING

Mater Adult Hospital

South Brisbane, Queensland, 4101, Australia

RECRUITING

East Coast Cancer Centre

Tugun, Queensland, 4224, Australia

RECRUITING

Urological Solutions

Ashford, South Australia, 5035, Australia

RECRUITING

Repatriation General Hospital

Daws Park, South Australia, 5041, Australia

RECRUITING

Peter MacCallum Cancer Centre

East Melbourne, Victoria, 3002, Australia

RECRUITING

Geelong Hospital

Geelong, Victoria, 3200, Australia

RECRUITING

Alfred Hospital

Melbourne, Victoria, 3004, Australia

RECRUITING

West Gippsland Hospital

Warragul, Victoria, 3820, Australia

RECRUITING

Christchurch Hospital

Christchurch, 1, Australia

RECRUITING

Dunedin Hospital

Dunedin, New Zealand

RECRUITING

Waikato Hospital

Hamilton, 2020, New Zealand

RECRUITING

Palmerston North Hospital

Palmerston North, New Zealand

RECRUITING

Related Publications (2)

• 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 DERIVED

• 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 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Androgen Antagonists; Orchiectomy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Castration; Endocrine Surgical Procedures; Surgical Procedures, Operative; Urogenital Surgical Procedures; Urologic Surgical Procedures, Male; Urologic Surgical Procedures

Study Officials

• Gillian M. Duchesne, MD, FRCR

  Peter MacCallum Cancer Centre, Australia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 3, 2005
• First Posted: May 4, 2005
• Study Start: October 1, 2004
• Primary Completion: December 1, 2009
• Last Updated: August 7, 2013

Record last verified: 2009-06

Locations

NZ (3); AU (17)