Prostate CancerPhase 3NCT00110162
Androgen Deprivation Therapy in Treating Patients With Prostate Cancer
A Phase 3 study testing antiandrogen therapy, releasing hormone agonist therapy and orchiectomy in people with Prostate Cancer, run by Peter MacCallum Cancer Centre, Australia at 20 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- antiandrogen therapy, releasing hormone agonist therapy and orchiectomy
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 20 sitesin 2 countries
- Study dates
- Oct 2004to Dec 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
Australia17 sites, 17 recruiting
- Recruiting
Urological Solutions
Ashford, South Australia, 5035
Graham Sinclair, MD, 61-8-8297-3877
- Recruiting
Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4029
Lizbeth Kenny, MD, 61-7-3636-8111, lizkenny@bigpond.net.au
- Recruiting
Princess Alexandra Hospital
Brisbane, Queensland, 4102
Margot Lehman, 61-7-3240-6799
- Recruiting
Cancer Therapy Centre at Campbelltown Hospital
Campbelltown, New South Wales, 2560
Martin P. Berry, 61-2-4636-4375, martin.berry@swsahs.nsw.gov.au
- Recruiting
Christchurch Hospital
Christchurch, 1
Chris Atkinson, 64-3-364-0020
- Recruiting
Concord Repatriation General Hospital
Concord, New South Wales, 2139
George Hruby, MD, 61-2-9767-5112
- Recruiting
Repatriation General Hospital
Daws Park, South Australia, 5041
Alan Stapleton, 61-8-8275-1927, alan.stapleton@rgh.sa.gov.au
- Recruiting
Peter MacCallum Cancer Centre
East Melbourne, Victoria, 3002
Gillian M. Duchesne, MD, FRCR, 61-3-9656-1004, gillian.duchesne@petermac.org
- Recruiting
Geelong Hospital
Geelong, Victoria, 3200
Michael Francis, MBBS, FRACR, 6-13-5226-7644
- Recruiting
Nepean Cancer Care Centre at Nepean Hospital
Kingswood, New South Wales, 2747
Viet Do, 61-2-4734-3500
- Recruiting
Cancer Therapy Centre at Liverpool Hospital
Liverpool, New South Wales, 2170
Andrew Kneebone, 6-12-9828-5282, andrew.kneebone@swsahs.gov.au
- Recruiting
Alfred Hospital
Melbourne, Victoria, 3004
Jeremy Millar, 61-3-9276-2337, jeremy.millar@med.monash.edu.au
- Recruiting
Mater Adult Hospital
South Brisbane, Queensland, 4101
Guy Bryant, 6-17-3840-3255, guy-bryant@health.qld.gov.au
- Recruiting
Sydney Cancer Centre at Royal Prince Alfred Hospital
Sydney, New South Wales, 2050
George Hruby, MD, 61-2-9515-8057, ghruby@email.cs.nsw.gov.au
- Recruiting
East Coast Cancer Centre
Tugun, Queensland, 4224
David Christie, MD, 61-7-5598-0366
- Recruiting
West Gippsland Hospital
Warragul, Victoria, 3820
William Straffon, MD, 61-3-5623-0857
- Recruiting
Westmead Institute for Cancer Research at Westmead Hospital
Westmead, New South Wales, 2145
Sandra Turner, 61-2-9845-6499
New Zealand3 sites, 3 recruiting
- Recruiting
Dunedin Hospital
Dunedin
John North, 64-3-474-7947, johnn@healthotago.co.nz
- Recruiting
Waikato Hospital
Hamilton, 2020
Leanne Tyrie, 64-7-839-8976
- Recruiting
Palmerston North Hospital
Palmerston North
Johan S. Nel, MD, 64-6-350-8430
About this study
Official title: A Collaborative Randomized Phase III Trial: The Timing of Intervention With Androgen Deprivation in Prostate Cancer Patients With Rising PSA
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- antiandrogen therapy, releasing hormone agonist therapy, orchiectomy
- 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
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antiandrogen therapyDrug
releasing hormone agonist therapyDrug
orchiectomyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2005 (estimated)
- Study startOct 2004
- Primary completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peter MacCallum Cancer Centre, Australia
- Sponsor type
- University, hospital or other
- Investigators
- Gillian M. Duchesne, MD, FRCR, Study chair, Peter MacCallum Cancer Centre, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00110162
- Sponsor's protocol ID
- PMCC-VCOG-PR-0103
- Other IDs
- CDR0000413706, PMCC-TROG-0306
- Status last verified
- Jun 2009
- First submitted
- 3 May 2005
- Last updated
- 7 Aug 2013
- Results posted
- No
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.
PubMed 28760403Duchesne 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.
PubMed 27155740
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Collaborative Randomized Phase III Trial: The Timing of Intervention With Androgen Deprivation in Prostate Cancer Patients With Rising PSA
- ClinicalTrials.gov ID
- NCT00110162
- Acronym / sponsor ID
- PMCC-VCOG-PR-0103
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Peter MacCallum Cancer Centre, AustraliaUniversity, hospital or other
- Study start
- Oct 2004
- Primary completion
- Dec 2009 (estimated)
- First posted
- 4 May 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antiandrogen therapy | Drug | – |
| releasing hormone agonist therapy | Drug | – |
| orchiectomy | Procedure or surgery | – |
Primary outcome
Death from any cause at 8 years
9 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
- Derived from this study: PubMed 28760403Duchesne 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.
- Derived from this study: PubMed 27155740Duchesne 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cancer Therapy Centre at Campbelltown Hospital
Campbelltown, Australia
Gillian M. Duchesne, MD, FRCR study chair
Peter MacCallum Cancer Centre, Australia
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing antiandrogen therapy, releasing hormone agonist therapy and orchiectomy in people with Prostate Cancer, run by Peter MacCallum Cancer Centre, Australia at 20 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death from any cause at 8 years. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00110162, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2013.