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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00110162
Registration number
NCT00110162
Ethics application status
Date submitted
3/05/2005
Date registered
4/05/2005
Date last updated
7/08/2013
Titles & IDs
Public title
Androgen Deprivation Therapy in Treating Patients With Prostate Cancer
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Scientific title
A Collaborative Randomized Phase III Trial: The Timing of Intervention With Androgen Deprivation in Prostate Cancer Patients With Rising PSA
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Secondary ID [1]
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CDR0000413706
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Secondary ID [2]
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PMCC-VCOG-PR-0103
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer
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Condition category
Condition code
Cancer
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Death from any cause at 8 years
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [1]
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Cancer specific survival
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [2]
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Clinical progression
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Assessment method [2]
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Timepoint [2]
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Secondary outcome [3]
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Time to first androgen independence
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Assessment method [3]
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Timepoint [3]
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Secondary outcome [4]
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Complication rate incidence and timing (e.g., cord compression, pathological fracture)
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Assessment method [4]
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Timepoint [4]
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Secondary outcome [5]
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Treatment-related morbidity (including cognitive, osteoporosis)
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Assessment method [5]
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Timepoint [5]
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Secondary outcome [6]
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Prognostic factors for progression (delayed group)
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Assessment method [6]
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Timepoint [6]
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Secondary outcome [7]
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EORTC Quality of life - general QLQC30 and prostate module for Quality of life annually for 5 years
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Assessment method [7]
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Timepoint [7]
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Secondary outcome [8]
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CTC v3.0 Survival endpoints: actuarial analysis at eight years
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Assessment method [8]
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Timepoint [8]
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Secondary outcome [9]
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Morbidity continuously
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Assessment method [9]
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Timepoint [9]
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Eligibility
Key inclusion 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
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Minimum age
No limit
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2004
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
2000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Cancer Therapy Centre at Campbelltown Hospital - Campbelltown
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Recruitment hospital [2]
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Concord Repatriation General Hospital - Concord
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Recruitment hospital [3]
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Nepean Cancer Care Centre at Nepean Hospital - Kingswood
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Recruitment hospital [4]
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Cancer Therapy Centre at Liverpool Hospital - Liverpool
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Recruitment hospital [5]
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Sydney Cancer Centre at Royal Prince Alfred Hospital - Sydney
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Recruitment hospital [6]
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Westmead Institute for Cancer Research at Westmead Hospital - Westmead
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Recruitment hospital [7]
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Royal Brisbane and Women's Hospital - Brisbane
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Recruitment hospital [8]
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Princess Alexandra Hospital - Brisbane
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Recruitment hospital [9]
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Mater Adult Hospital - South Brisbane
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Recruitment hospital [10]
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East Coast Cancer Centre - Tugun
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Recruitment hospital [11]
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Urological Solutions - Ashford
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Recruitment hospital [12]
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Repatriation General Hospital - Daws Park
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Recruitment hospital [13]
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Peter MacCallum Cancer Centre - East Melbourne
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Recruitment hospital [14]
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Geelong Hospital - Geelong
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Recruitment hospital [15]
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Alfred Hospital - Melbourne
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Recruitment hospital [16]
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West Gippsland Hospital - Warragul
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Recruitment hospital [17]
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Christchurch Hospital - Christchurch
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Recruitment postcode(s) [1]
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2560 - Campbelltown
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Recruitment postcode(s) [2]
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2139 - Concord
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Recruitment postcode(s) [3]
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2747 - Kingswood
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Recruitment postcode(s) [4]
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2170 - Liverpool
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Recruitment postcode(s) [5]
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2050 - Sydney
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Recruitment postcode(s) [6]
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2145 - Westmead
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Recruitment postcode(s) [7]
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4029 - Brisbane
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Recruitment postcode(s) [8]
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4102 - Brisbane
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Recruitment postcode(s) [9]
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4101 - South Brisbane
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Recruitment postcode(s) [10]
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4224 - Tugun
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Recruitment postcode(s) [11]
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5035 - Ashford
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Recruitment postcode(s) [12]
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5041 - Daws Park
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Recruitment postcode(s) [13]
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3002 - East Melbourne
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Recruitment postcode(s) [14]
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3200 - Geelong
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Recruitment postcode(s) [15]
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3004 - Melbourne
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Recruitment postcode(s) [16]
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3820 - Warragul
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Recruitment postcode(s) [17]
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1 - Christchurch
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Dunedin
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Country [2]
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New Zealand
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State/province [2]
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Hamilton
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Country [3]
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New Zealand
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State/province [3]
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Palmerston North
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Funding & Sponsors
Primary sponsor type
Other
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Name
Peter MacCallum Cancer Centre, Australia
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00110162
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Trial related presentations / publications
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. doi: 10.1016/S1470-2045(16)30169-3. Lancet Oncol. 2017 Sep;18(9):e510. doi: 10.1016/S1470-2045(17)30575-2.
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Public notes
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Contacts
Principal investigator
Name
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Gillian M. Duchesne, MD, FRCR
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Address
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Peter MacCallum Cancer Centre, Australia
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00110162
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