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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
Treatment: Drugs - antiandrogen therapy
Treatment: Drugs - releasing hormone agonist therapy
Treatment: Surgery - orchiectomy
Treatment: Drugs: antiandrogen therapy
Treatment: Drugs: releasing hormone agonist therapy
Treatment: Surgery: orchiectomy
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Surgery
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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 status
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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/ct2/show/NCT00110162
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Trial related presentations / publications
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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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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00110162
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