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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
Scientific title
A Collaborative Randomized Phase III Trial: The Timing of Intervention With Androgen Deprivation in Prostate Cancer Patients With Rising PSA
Secondary ID [1] 0 0
CDR0000413706
Secondary ID [2] 0 0
PMCC-VCOG-PR-0103
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Death from any cause at 8 years
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Cancer specific survival
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Clinical progression
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Time to first androgen independence
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Complication rate incidence and timing (e.g., cord compression, pathological fracture)
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Treatment-related morbidity (including cognitive, osteoporosis)
Timepoint [5] 0 0
Secondary outcome [6] 0 0
Prognostic factors for progression (delayed group)
Timepoint [6] 0 0
Secondary outcome [7] 0 0
EORTC Quality of life - general QLQC30 and prostate module for Quality of life annually for 5 years
Timepoint [7] 0 0
Secondary outcome [8] 0 0
CTC v3.0 Survival endpoints: actuarial analysis at eight years
Timepoint [8] 0 0
Secondary outcome [9] 0 0
Morbidity continuously
Timepoint [9] 0 0

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
Minimum age
No limit
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Cancer Therapy Centre at Campbelltown Hospital - Campbelltown
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [3] 0 0
Nepean Cancer Care Centre at Nepean Hospital - Kingswood
Recruitment hospital [4] 0 0
Cancer Therapy Centre at Liverpool Hospital - Liverpool
Recruitment hospital [5] 0 0
Sydney Cancer Centre at Royal Prince Alfred Hospital - Sydney
Recruitment hospital [6] 0 0
Westmead Institute for Cancer Research at Westmead Hospital - Westmead
Recruitment hospital [7] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [8] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [9] 0 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [10] 0 0
East Coast Cancer Centre - Tugun
Recruitment hospital [11] 0 0
Urological Solutions - Ashford
Recruitment hospital [12] 0 0
Repatriation General Hospital - Daws Park
Recruitment hospital [13] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment hospital [14] 0 0
Geelong Hospital - Geelong
Recruitment hospital [15] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [16] 0 0
West Gippsland Hospital - Warragul
Recruitment hospital [17] 0 0
Christchurch Hospital - Christchurch
Recruitment postcode(s) [1] 0 0
2560 - Campbelltown
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2747 - Kingswood
Recruitment postcode(s) [4] 0 0
2170 - Liverpool
Recruitment postcode(s) [5] 0 0
2050 - Sydney
Recruitment postcode(s) [6] 0 0
2145 - Westmead
Recruitment postcode(s) [7] 0 0
4029 - Brisbane
Recruitment postcode(s) [8] 0 0
4102 - Brisbane
Recruitment postcode(s) [9] 0 0
4101 - South Brisbane
Recruitment postcode(s) [10] 0 0
4224 - Tugun
Recruitment postcode(s) [11] 0 0
5035 - Ashford
Recruitment postcode(s) [12] 0 0
5041 - Daws Park
Recruitment postcode(s) [13] 0 0
3002 - East Melbourne
Recruitment postcode(s) [14] 0 0
3200 - Geelong
Recruitment postcode(s) [15] 0 0
3004 - Melbourne
Recruitment postcode(s) [16] 0 0
3820 - Warragul
Recruitment postcode(s) [17] 0 0
1 - Christchurch
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Dunedin
Country [2] 0 0
New Zealand
State/province [2] 0 0
Hamilton
Country [3] 0 0
New Zealand
State/province [3] 0 0
Palmerston North

Funding & Sponsors
Primary sponsor type
Other
Name
Peter MacCallum Cancer Centre, Australia
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00110162
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.
Public notes

Contacts
Principal investigator
Name 0 0
Gillian M. Duchesne, MD, FRCR
Address 0 0
Peter MacCallum Cancer Centre, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00110162