Prostate CancerPhase 2NCT00031889
Exemestane With or Without Bicalutamide in Treating Patients With Stage IV Prostate Cancer
A Phase 2 study testing Exemestane and Exemestane+bicalutamide in people with Prostate Cancer, run by Swiss Cancer Institute at 12 sites in Switzerland.
Trial summary
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using exemestane plus bicalutamide may fight prostate cancer by reducing the production of androgens. It is not yet known if exemestane is more effective with or without bicalutamide in treating 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?
- Exemestane and Exemestane+bicalutamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 12 sitesSwitzerland
- Study dates
- Aug 2001to Jun 2002
- Phase
- Phase 2
- 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:
- Histologically or cytologically confirmed stage IV adenocarcinoma of the prostate
- Documented disease progression based on prostate-specific antigen (PSA) progression during first-line androgen suppression (luteinizing hormone-releasing hormone agonist or orchiectomy)
- PSA progression is defined by the following:
- Interval of at least 1 week between reference value (time point value 1) and the next PSA level (time point value 2)
- PSA at time point value 3 is greater than PSA at time point value 2 OR
- PSA at time point value 3 is not greater than PSA at time point value 2, but PSA at time point value 4 is greater than PSA at time point value 2
- PSA at least 5 ng/mL
- Must continue primary androgen suppression if no prior surgical castration
- No known leptomeningeal or brain metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- WHO 0-2
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,500/mm^3
- Neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 9 g/dL
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST and ALT no greater than 2.5 times ULN
Renal:
- Creatinine no greater than 1.5 times ULN
Other:
- No acute concurrent severe infection
- No other concurrent significant disease that would preclude study therapy
- No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior antibody or gene therapy
Chemotherapy:
- No prior cytostatic agents
Endocrine therapy:
- See Disease Characteristics
- No prior estramustine
- No prior antiandrogens (e.g., bicalutamide)
- No concurrent estrogen-containing medicine
Radiotherapy:
- More than 4 weeks since prior radiotherapy
- No concurrent radiotherapy to more than 1 field
Surgery:
- See Disease Characteristics
Other:
- At least 4 weeks since prior investigational drugs
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Switzerland12 sites
Kantonspital Aarau
Aarau, 5001
University Hospital
Basel, CH-4031
Inselspital, Bern
Bern, CH-3010
Spitalzentrum Biel
Biel, CH-2500
Kantonsspital Bruderholz
Bruderholz, CH-4101
Ratisches Kantons und Regionalspital
Chur, CH-7000
Clinique De Genolier
Genolier, Ch-1272
Centre Hospitalier Universitaire Vaudois
Lausanne, CH-1011
Istituto Oncologico della Svizzera Italiana
Lugano, CH-6900
Ospedale Beata Vergine
Mendrisio, CH-6850
Institut Central des Hopitaux Valaisans
Sion, CH1951
Universitaetsspital
Zurich, CH-8091
About this study
Official title: A Randomized Phase II Trial of Exemestane With and Without Bicalutamide as Second Line Therapy After Failure of Androgen Suppression in Advanced Prostate Cancer
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using exemestane plus bicalutamide may fight prostate cancer by reducing the production of androgens. It is not yet known if exemestane is more effective with or without bicalutamide in treating prostate cancer.
PURPOSE: Randomized phase II trial to study the effectiveness of exemestane with or without bicalutamide in treating patients who have stage IV prostate cancer that has been previously treated with hormone therapy or surgery.
Read the detailed description
OBJECTIVES:
- Compare the efficacy and tolerability of exemestane with or without bicalutamide as second-line therapy after failure of androgen suppression (luteinizing hormone-releasing hormone agonist or orchiectomy) in patients with stage IV prostate cancer.
- Determine the potential antagonistic effect of the weak androgen action of exemestane when combined with bicalutamide in these patients.
- Compare the quality of life (QOL) in patients treated with these regimens.
- Correlate prostate-specific antigen response and data of QOL, including scores for pain intensity and analgesic consumption, in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to performance status (0 vs 1-2), pain (none or mild vs moderate or severe), and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral exemestane once daily.
- Arm II: Patients receive exemestane as in arm I and oral bicalutamide once daily.
Treatment in both arms continues every 4 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.
Quality of life and pain are assessed at baseline, on day 1 of course 2 and any subsequent courses, and at disease progression or treatment failure (if applicable).
Patients are followed monthly until disease progression.
PROJECTED ACCRUAL: A total of 20-62 patients (10-31 per treatment arm) will be accrued for this study.
- Conditions
- Prostate Cancer
- Being tested
- Exemestane, Exemestane+bicalutamide
- Keywords
- adenocarcinoma of the prostate, 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.
ExemestaneDrug
Exemestane
Exemestane+bicalutamideDrug
Exemestane as in arm I and oral bicalutamide once daily
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Active comparator | Patients receive oral exemestane once daily Receives: Drug: Exemestane |
| Arm II | Active comparator | Patients receive exemestane as in arm I and oral bicalutamide once daily Receives: Drug: Exemestane+bicalutamide |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2003 (estimated)
- Study startAug 2001
- Primary completionJun 2002
- Study completionJun 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco Bonomo, MD, Study chair, Ospedale Beata Vergine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00031889
- Sponsor's protocol ID
- SAKK 09/01
- Other IDs
- EU-20139
- Status last verified
- May 2012
- First submitted
- 8 Mar 2002
- Last updated
- 15 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial of Exemestane With and Without Bicalutamide as Second Line Therapy After Failure of Androgen Suppression in Advanced Prostate Cancer
- ClinicalTrials.gov ID
- NCT00031889
- Acronym / sponsor ID
- SAKK 09/01
- Conditions
- Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Swiss Cancer InstituteUniversity, hospital or other
- Study start
- Aug 2001
- Primary completion
- Jun 2002 (actual)
- Study completion
- Jun 2002 (actual)
- First posted
- 1 Jul 2003 (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 stimulate the growth of prostate cancer cells. Hormone therapy using exemestane plus bicalutamide may fight prostate cancer by reducing the production of androgens. It is not yet known if exemestane is more effective with or without bicalutamide in treating prostate cancer.
PURPOSE: Randomized phase II trial to study the effectiveness of exemestane with or without bicalutamide in treating patients who have stage IV prostate cancer that has been previously treated with hormone therapy or surgery.
Detailed description
OBJECTIVES:
- Compare the efficacy and tolerability of exemestane with or without bicalutamide as second-line therapy after failure of androgen suppression (luteinizing hormone-releasing hormone agonist or orchiectomy) in patients with stage IV prostate cancer.
- Determine the potential antagonistic effect of the weak androgen action of exemestane when combined with bicalutamide in these patients.
- Compare the quality of life (QOL) in patients treated with these regimens.
- Correlate prostate-specific antigen response and data of QOL, including scores for pain intensity and analgesic consumption, in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to performance status (0 vs 1-2), pain (none or mild vs moderate or severe), and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral exemestane once daily.
- Arm II: Patients receive exemestane as in arm I and oral bicalutamide once daily.
Treatment in both arms continues every 4 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.
Quality of life and pain are assessed at baseline, on day 1 of course 2 and any subsequent courses, and at disease progression or treatment failure (if applicable).
Patients are followed monthly until disease progression.
PROJECTED ACCRUAL: A total of 20-62 patients (10-31 per treatment arm) will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Active comparator | Drug: ExemestanePatients receive oral exemestane once daily |
| Arm II | Active comparator | Drug: Exemestane+bicalutamidePatients receive exemestane as in arm I and oral bicalutamide once daily |
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 |
|---|---|---|
| ExemestaneExemestane | Drug | Arm I |
| Exemestane+bicalutamideExemestane as in arm I and oral bicalutamide once daily | Drug | Arm II |
Primary outcome
Not reported in the source record.
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 15 May 2012.
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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.
Marco Bonomo, MD study chair
Ospedale Beata Vergine
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Exemestane and Exemestane+bicalutamide in people with Prostate Cancer, run by Swiss Cancer Institute at 12 sites in Switzerland.
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 15 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Switzerland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
Where can I read the original study information?
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 15 May 2012.