Prostate CancerPhase 3NCT00316927
Dexamethasone, Aspirin, and Diethylstilbestrol in Treating Patients With Locally Advanced or Metastatic Prostate Cancer
A Phase 3 study testing acetylsalicylic acid, dexamethasone and diethylstilbestrol in people with Prostate Cancer, run by St. Bartholomew's Hospital at 15 sites in United Kingdom.
Trial summary
RATIONALE: Giving dexamethasone together with aspirin and diethylstilbestrol may be effective in lowering prostate-specific antigen levels and may slow or stop the growth of prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- acetylsalicylic acid, dexamethasone and diethylstilbestrol
- How many people
- 260 participants
- Where
- 15 sitesUnited Kingdom
- Study dates
- Dec 2002to Apr 2007
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of adenocarcinoma of the prostate
- Elevated prostate-specific antigen (PSA)
- Failed previous treatments, including gonadatropan regulatory hormone analogue therapy, radiotherapy, surgery, or any combination of these
- Biochemically castrate (testosterone < 1 nmol/L) at baseline
PATIENT CHARACTERISTICS:
- Life expectancy ≥ 3 months
- ECOG performance status 0-3
- WBC ≥ 3,000/mm^3
- Absolute neutrophil count (neutrophils and bands) ≥ 2,000/mm^3
- Platelet count ≥ 50,000/mm^3
- Bilirubin ≤ 2 times upper limit of normal (ULN)
- AST or ALT ≤ 3 times ULN
- Creatinine ≤ 1.5 times ULN
- Able to swallow tablets
- No other malignancy within the past 3 years except basal cell skin cancer
- No previous thromboembolic disease, including stroke, venous or arterial thrombosis, and myocardial infarction with ongoing angina pectoris
- Prior uncomplicated myocardial infarction allowed
- No diabetes mellitus if treatment titration is thought to be difficult or inappropriate
- No active gastric or duodenal ulcer
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Prior concurrent bisphosphonates allowed
- No concurrent investigational agents or participation in another investigational drug study
- No other concurrent antineoplastic therapy, including new estrogen therapy, radiation therapy, or PC-SPES
- No other concurrent corticosteroids (e.g., dexamethasone for nausea or vomiting) except those prescribed in the study regimen
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United Kingdom15 sites
Bristol Haematology and Oncology Centre
Bristol, England, BS2 8ED
Burnley General Hospital
Burnley, England, BB10 2PQ
Kent and Canterbury Hospital
Canterbury, England, CT2 3NG
Eastbourne District General Hospital
Eastbourne, England, BN21 2UD
Whipps Cross Hospital
London, England, E11 1NR
Saint Bartholomew's Hospital
London, England, EC1A 7BE
Chelsea Westminster Hospital
London, England, SW10 9NH
Maidstone Hospital
Maidstone, England, ME16 9QQ
Milton Keynes General Hospital
Milton Keynes, England, MK6 5LD
Churchill Hospital
Oxford, England, OX3 7LJ
Oldchurch Hospital
Romford, England, RM7 OBE
Torbay Hospital
Torquay Devon, England, TQ2 7AA
Weston General Hospital
Weston-super-Mare, England, BS23 4TQ
Worthing Hospital
Worthing, England, BN11 2DH
Cancer Care Centre at York Hospital
York, England, Y031 8HE
About this study
Official title: A Randomized Phase III Trial of Dexamethasone and Aspirin (DA) Versus Dexamethasone, Diethylstilbestrol and Aspirin (DAS) in Locally Advanced or Metastatic Cancer of the Prostate - Immediate Versus Deferred Diethylstilbestrol
RATIONALE: Giving dexamethasone together with aspirin and diethylstilbestrol may be effective in lowering prostate-specific antigen levels and may slow or stop the growth of prostate cancer. It is not yet known which schedule of dexamethasone, aspirin, and diethylstilbestrol is more effective in treating prostate cancer.
PURPOSE: This randomized phase III trial is studying dexamethasone and aspirin when given together with two different schedules of diethylstilbestrol to compare how well they work in treating patients with locally advanced or metastatic prostate cancer.
Read the detailed description
OBJECTIVES:
Primary
- Compare the prostate-specific antigen (PSA) response in patients with locally advanced or metastatic prostate cancer treated with dexamethasone and aspirin with delayed vs immediate diethylstilbestrol.
Secondary
- Compare the overall response rate in patients treated with these regimens.
- Compare the quality of life of patients treated with these regimens.
- Compare the progression-free and overall survival of patients treated with these regimens.
OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified according to ECOG performance status (0 vs 1-3), prostate-specific antigen (PSA) response to prior therapy (PSA normalization vs inability to normalize), and bone scan (positive vs negative for bony metastases). Patients are randomized to 1 of 2 treatment arms.
- Arm I (deferred diethylstilbestrol): Patients receive oral dexamethasone and oral acetylsalicyclic acid once daily (DA). Subsequent to treatment failure with DA, patients continue to receive DA as before in addition to oral diethylstilbestrol once daily (DAS). Treatment with DAS continues in the absence of disease progression or unacceptable toxicity.
- Arm II (immediate diethylstilbestrol): Patients receive oral dexamethasone, oral acetylsalicyclic acid, and oral diethylstilbestrol once daily (DAS). Treatment continues in the absence of disease progression or unacceptable toxicity.
Quality of life is evaluated monthly during study treatment.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 260 patients will be accrued for this study.
- Conditions
- Prostate Cancer
- Being tested
- acetylsalicylic acid, dexamethasone, diethylstilbestrol
- Keywords
- adenocarcinoma of the prostate, stage III prostate cancer, stage IV 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.
acetylsalicylic acidDrug
dexamethasoneDrug
diethylstilbestrolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostate-specific antigen (PSA) response
Secondary outcomes (3)
Overall response
Quality of life
Progression-free and overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2006 (estimated)
- Study startDec 2002
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Bartholomew's Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jonathan Shamash, MD, FRCP, Study chair, St. Bartholomew's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00316927
- Sponsor's protocol ID
- BARTS-DAVDAS
- Other IDs
- CDR0000472404, EU-20610, ISRCTN13255144
- Status last verified
- Apr 2007
- First submitted
- 19 Apr 2006
- Last updated
- 26 Jun 2013
- Results posted
- No
Publications
Shamash J, Powles T, Sarker SJ, Protheroe A, Mithal N, Mills R, Beard R, Wilson P, Tranter N, O'Brien N, McFaul S, Oliver T. A multi-centre randomised phase III trial of Dexamethasone vs Dexamethasone and diethylstilbestrol in castration-resistant prostate cancer: immediate vs deferred Diethylstilbestrol. Br J Cancer. 2011 Feb 15;104(4):620-8. doi: 10.1038/bjc.2011.7. Epub 2011 Feb 1.
PubMed 21285990
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Trial of Dexamethasone and Aspirin (DA) Versus Dexamethasone, Diethylstilbestrol and Aspirin (DAS) in Locally Advanced or Metastatic Cancer of the Prostate - Immediate Versus Deferred Diethylstilbestrol
- ClinicalTrials.gov ID
- NCT00316927
- Acronym / sponsor ID
- BARTS-DAVDAS
- Conditions
- Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, stage III prostate cancer, stage IV prostate cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- St. Bartholomew's HospitalUniversity, hospital or other
- Study start
- Dec 2002
- Study completion
- Apr 2007 (actual)
- First posted
- 21 Apr 2006 (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: Giving dexamethasone together with aspirin and diethylstilbestrol may be effective in lowering prostate-specific antigen levels and may slow or stop the growth of prostate cancer. It is not yet known which schedule of dexamethasone, aspirin, and diethylstilbestrol is more effective in treating prostate cancer.
PURPOSE: This randomized phase III trial is studying dexamethasone and aspirin when given together with two different schedules of diethylstilbestrol to compare how well they work in treating patients with locally advanced or metastatic prostate cancer.
Detailed description
OBJECTIVES:
Primary
- Compare the prostate-specific antigen (PSA) response in patients with locally advanced or metastatic prostate cancer treated with dexamethasone and aspirin with delayed vs immediate diethylstilbestrol.
Secondary
- Compare the overall response rate in patients treated with these regimens.
- Compare the quality of life of patients treated with these regimens.
- Compare the progression-free and overall survival of patients treated with these regimens.
OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified according to ECOG performance status (0 vs 1-3), prostate-specific antigen (PSA) response to prior therapy (PSA normalization vs inability to normalize), and bone scan (positive vs negative for bony metastases). Patients are randomized to 1 of 2 treatment arms.
- Arm I (deferred diethylstilbestrol): Patients receive oral dexamethasone and oral acetylsalicyclic acid once daily (DA). Subsequent to treatment failure with DA, patients continue to receive DA as before in addition to oral diethylstilbestrol once daily (DAS). Treatment with DAS continues in the absence of disease progression or unacceptable toxicity.
- Arm II (immediate diethylstilbestrol): Patients receive oral dexamethasone, oral acetylsalicyclic acid, and oral diethylstilbestrol once daily (DAS). Treatment continues in the absence of disease progression or unacceptable toxicity.
Quality of life is evaluated monthly during study treatment.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 260 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| acetylsalicylic acid | Drug | – |
| dexamethasone | Drug | – |
| diethylstilbestrol | Drug | – |
Primary outcome
Prostate-specific antigen (PSA) response
3 secondary outcomes
Overall response
Quality of life
Progression-free and overall survival
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2013.
- Results publication: PubMed 21285990Shamash J, Powles T, Sarker SJ, Protheroe A, Mithal N, Mills R, Beard R, Wilson P, Tranter N, O'Brien N, McFaul S, Oliver T. A multi-centre randomised phase III trial of Dexamethasone vs Dexamethasone and diethylstilbestrol in castration-resistant prostate cancer: immediate vs deferred Diethylstilbestrol. Br J Cancer. 2011 Feb 15;104(4):620-8. doi: 10.1038/bjc.2011.7. Epub 2011 Feb 1.
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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.
Jonathan Shamash, MD, FRCP study chair
St. Bartholomew's Hospital
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing acetylsalicylic acid, dexamethasone and diethylstilbestrol in people with Prostate Cancer, run by St. Bartholomew's Hospital at 15 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prostate-specific antigen (PSA) response. 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 NCT00316927, which also lists 1 linked publication.
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 26 Jun 2013.