Prostate CancerPhase 3NCT00014586
Bicalutamide Compared With Observation Followed by Bicalutamide Plus Either Goserelin or Orchiectomy in Treating Patients With Prostate Cancer
A Phase 3 study testing bicalutamide, goserelin acetate and orchiectomy in people with Prostate Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 1 site in Germany.
Trial summary
RATIONALE: Testosterone can stimulate the growth of cancer cells. Bicalutamide and goserelin may fight prostate cancer by reducing the production of testosterone. It is not yet known which hormone therapy regimen is most effective for prostate cancer. Read more about this study
- Who is it for?
- Ages Up to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- bicalutamide, goserelin acetate and orchiectomy
- Type of treatment
- Surgery or procedure
- How many people
- 110 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2001to Feb 2003
- 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 Up to 80 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed prostate cancer
- T1-3, any G (any Gleason), N0 or NX
- High risk defined as G3 or Gleason more than 6 or PSA more than 20 ng/mL and unfit or unwilling to undergo local curative therapy OR
- Low risk defined as G1-2 or Gleason less than 7 and PSA no more than 20 ng/mL and no prior local curative therapy
- Asymptomatic (pain score of 0)
- PSA no more than 100 ng/mL (no more than 25 times normal)
- No metastatic disease by chest x-ray, bone scan (if PSA more than 10 ng/mL or 2.5 times normal), and pelvic CT (if chance of lymph node metastases is at least 5% by Partin tables)
- No bone disease that would interfere with diagnosis of metastatic disease
PATIENT CHARACTERISTICS:
Age:
- 80 and under
Performance status:
- WHO 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No other malignancy within the past 5 years except adequately treated basal cell skin cancer
- No psychological, personal, sociological, or geographical condition that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Phase III Step-Up Study On Initial Antiandrogen Monotherapy In Comparison With Watchful Waiting In Asymptomatic T1-3 Any G (Any Gleason) NO or Nx M0 Prostate Cancer Patients Without Local Treatment With Curative Intent
RATIONALE: Testosterone can stimulate the growth of cancer cells. Bicalutamide and goserelin may fight prostate cancer by reducing the production of testosterone. It is not yet known which hormone therapy regimen is most effective for prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of bicalutamide with that of observation followed by bicalutamide plus either goserelin or orchiectomy for patients who have prostate cancer.
Read the detailed description
OBJECTIVES:
- Compare the overall and cancer-specific survival of patients with prostate cancer treated with bicalutamide alone followed by bicalutamide with either goserelin or bilateral orchiectomy vs observation followed by bicalutamide with either goserelin or bilateral orchiectomy.
- Compare the time to first and second clinical progression in patients treated with these regimens.
- Compare the quality of life, including potency, of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, tumor differentiation grade (G3 or Gleason more than 6 vs other values), T category, comorbidity (i.e., chronic disease) (yes vs no), potency (yes vs no), type of chosen hormonal ablation (goserelin vs orchiectomy), PSA level (less than 10 ng/mL vs 10-20 ng/mL vs 20-100 ng/mL), and N status (N0 vs NX). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive oral bicalutamide once daily. At first symptomatic disease progression, patients also receive goserelin subcutaneously once every 28 or 84 days or undergo bilateral orchiectomy. At second disease progression, patients discontinue bicalutamide.
- Arm II: Patients are observed until first symptomatic disease progression. At first disease progression, patients receive bicalutamide with either goserelin or bilateral orchiectomy as in arm I. Patients discontinue bicalutamide as in arm I.
Quality of life is assessed at baseline, every 6 months for 6 years, at each disease progression, and then annually thereafter.
Patients are followed annually.
PROJECTED ACCRUAL: Approximately 1266 patients (633 per treatment arm) will be accrued for this study within 5 years.
- Conditions
- Prostate Cancer
- Being tested
- bicalutamide, goserelin acetate, orchiectomy
- Keywords
- stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III 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.
bicalutamideDrug
goserelin acetateDrug
orchiectomyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJan 2001
- Primary completionFeb 2003
Why it stopped: low accrual
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.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- 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
- 110 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Gerald H.J. Mickisch, MD, Study chair, Center of Operative Urology Bremen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00014586
- Sponsor's protocol ID
- EORTC-30991
- Other IDs
- EORTC-GU-30991
- Status last verified
- Sep 2012
- First submitted
- 10 Apr 2001
- Last updated
- 24 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase III Step-Up Study On Initial Antiandrogen Monotherapy In Comparison With Watchful Waiting In Asymptomatic T1-3 Any G (Any Gleason) NO or Nx M0 Prostate Cancer Patients Without Local Treatment With Curative Intent
- ClinicalTrials.gov ID
- NCT00014586
- Acronym / sponsor ID
- EORTC-30991
- Conditions
- Prostate Cancer
- Keywords
- stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 110 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Jan 2001
- Primary completion
- Feb 2003 (actual)
- First posted
- 27 Jan 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: Testosterone can stimulate the growth of cancer cells. Bicalutamide and goserelin may fight prostate cancer by reducing the production of testosterone. It is not yet known which hormone therapy regimen is most effective for prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of bicalutamide with that of observation followed by bicalutamide plus either goserelin or orchiectomy for patients who have prostate cancer.
Detailed description
OBJECTIVES:
- Compare the overall and cancer-specific survival of patients with prostate cancer treated with bicalutamide alone followed by bicalutamide with either goserelin or bilateral orchiectomy vs observation followed by bicalutamide with either goserelin or bilateral orchiectomy.
- Compare the time to first and second clinical progression in patients treated with these regimens.
- Compare the quality of life, including potency, of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, tumor differentiation grade (G3 or Gleason more than 6 vs other values), T category, comorbidity (i.e., chronic disease) (yes vs no), potency (yes vs no), type of chosen hormonal ablation (goserelin vs orchiectomy), PSA level (less than 10 ng/mL vs 10-20 ng/mL vs 20-100 ng/mL), and N status (N0 vs NX). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive oral bicalutamide once daily. At first symptomatic disease progression, patients also receive goserelin subcutaneously once every 28 or 84 days or undergo bilateral orchiectomy. At second disease progression, patients discontinue bicalutamide.
- Arm II: Patients are observed until first symptomatic disease progression. At first disease progression, patients receive bicalutamide with either goserelin or bilateral orchiectomy as in arm I. Patients discontinue bicalutamide as in arm I.
Quality of life is assessed at baseline, every 6 months for 6 years, at each disease progression, and then annually thereafter.
Patients are followed annually.
PROJECTED ACCRUAL: Approximately 1266 patients (633 per treatment arm) will be accrued for this study within 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- Up to 80 years
- 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 |
|---|---|---|
| bicalutamide | Drug | – |
| goserelin acetate | Drug | – |
| orchiectomy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 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.
Gerald H.J. Mickisch, MD study chair
Center of Operative Urology Bremen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bicalutamide, goserelin acetate and orchiectomy in people with Prostate Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 1 site in Germany.
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: stopped early, as of the sponsor's last update on 24 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 was stopped early (reason given: low accrual). Results are not available in the source record.
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 24 Sep 2012.