Prostate CancerPhase 3NCT00363285
Cyproterone Acetate in Treating Patients With Newly Diagnosed Stage III or Stage IV Prostate Cancer
A Phase 3 study testing gonadotrophin releasing hormone, cyproterone acetate and quality-of-life assessment in people with Prostate Cancer, run by St. Bartholomew's Hospital at 2 sites in United Kingdom.
Trial summary
RATIONALE: Androgens can cause the growth of prostate cancer cells. Hormone therapy, such as cyproterone acetate may stop the adrenal glands from making androgens. Sometimes the tumor may not need treatment until it progresses. In this case, observation may be sufficient. Read more about this study
- Who is it for?
- Ages Up to 79 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- gonadotrophin releasing hormone, cyproterone acetate and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- How many people
- 900 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jan 2003to not given
- 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 79 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- T3 -T4, M0-M1 (stage III or IV disease)
- Prostate-specific antigen level ≥ 4 ng/mL and ≤ 100 ng/mL
PATIENT CHARACTERISTICS:
- Performance status 0-2
- Normal liver function
- No other neoplasia (except skin, excluding melanoma)
- No expected difficulties of follow-up related to psychiatric disorders, marked senility, or too large a distance between patient's home and investigator's center
- No severe chronic disease
PRIOR CONCURRENT THERAPY:
- No prior hormonal therapy or chemotherapy
- No prior surgery (radical prostatectomy), except transurethral resection, for M0 patients
- No prior radiotherapy to the primary tumor for M0 patients
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
Saint Bartholomew's Hospital
London, England, EC1A 7BE
R. T. Oliver, MD, 44-207-601-8522, r.t.oliver@qmul.ac.uk
- Recruiting
Scarborough General Hospital
Scarborough, England, YO12 6QL
Simon Hawkyard, MD, 44-1723-342-085
About this study
Official title: Intermittent Hormone Therapy for Newly Diagnosed Metastatic Prostate Cancer
RATIONALE: Androgens can cause the growth of prostate cancer cells. Hormone therapy, such as cyproterone acetate may stop the adrenal glands from making androgens. Sometimes the tumor may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether giving cyproterone acetate continuously is more effective than giving cyproterone acetate after tumor progression in treating prostate cancer.
PURPOSE: This randomized phase III trial is studying cyproterone acetate to compare how well it works when given continuously or after tumor progression in treating patients with newly diagnosed stage III or stage IV prostate cancer.
Read the detailed description
OBJECTIVES:
Primary
- Compare time to loss of androgen dependence, based on serum prostate-specific antigen failure, in patients with newly diagnosed stage III or IV prostate cancer treated with intermittent vs continuous androgen suppression comprising cyproterone acetate.
- Compare time to treatment failure (subjective or objective progression) in patients treated with these regimens.
- Compare quality of life of patients treated with these regimens.
- Compare survival of patients treated with these regimens.
Secondary
- Compare the side effects in patients treated with these regimens.
- Determine the first and total therapy-free intervals in patients treated with intermittent cyproterone acetate.
OUTLINE: This is a randomized, multicenter study.
All patients receive cyproterone acetate daily for 16 weeks. Patients also receive monthly injections of luteinizing hormone-releasing hormone (LHRH) agonist beginning in week 2 and continuing for 14 weeks. Patients with a prostate-specific antigen (PSA) level of ≤ 4 ng/mL and who are asymptomatic at 14 weeks are randomized to 1 of 2 treatment arms.
- Arm I (continuous maximum-androgen blockade): Patients receive cyproterone acetate daily and monthly LHRH agonist depot injections in the absence of disease progression or unacceptable toxicity. Patients may also undergo orchidectomy.
Quality of life is assessed every 6 months for 2 years and then annually thereafter.
- Arm II (intermittent treatment): Patients are observed after randomization. Treatment with daily cyproterone acetate resumes if symptoms demand hormone treatment and patient has any PSA level OR if patient is asymptomatic and has a PSA level ≥ 20 ng/mL. Treatment continues in the absence of disease progression or unacceptable toxicity. If after 9 months of treatment, a PSA level of ≤ 4 ng/mL is not achieved or the patient remains symptomatic, treatment is discontinued.
Quality of life is assessed every 6 months and when therapy is restarted.
Pain and performance status are assessed at each visit in both treatment arms.
After completion of study therapy, patients are followed periodically.
PROJECTED ACCRUAL: A total of 900 patients will be accrued for this study.
- Conditions
- Prostate Cancer
- Being tested
- gonadotrophin releasing hormone, cyproterone acetate, quality-of-life assessment
- 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.
gonadotrophin releasing hormoneBiological
cyproterone acetateDrug
quality-of-life assessmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to loss of androgen-dependence, based on serum prostate-specific antigen (PSA) failure according to protocol definition
Time to treatment failure (subjective or objective progression)
Quality of life
Survival
Secondary outcomes (2)
Side effects
First and total therapy-free intervals in patients treated with intermittent cyproterone acetate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startJan 2003
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Bartholomew's Hospital
- Sponsor type
- University, hospital or other
- Investigators
- R. T. Oliver, MD, Study chair, St. Bartholomew's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00363285
- Sponsor's protocol ID
- CDR0000495321
- Other IDs
- SEUG-9901, BARTS-SEUK-9901, MREC-04/5/006, BARTS-P/02/203, EU-20630
- Status last verified
- Oct 2006
- First submitted
- 10 Aug 2006
- Last updated
- 26 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Hormone Therapy for Newly Diagnosed Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT00363285
- Acronym / sponsor ID
- CDR0000495321
- Conditions
- Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, stage III prostate cancer, stage IV prostate cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- St. Bartholomew's HospitalUniversity, hospital or other
- Study start
- Jan 2003
- First posted
- 15 Aug 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: Androgens can cause the growth of prostate cancer cells. Hormone therapy, such as cyproterone acetate may stop the adrenal glands from making androgens. Sometimes the tumor may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether giving cyproterone acetate continuously is more effective than giving cyproterone acetate after tumor progression in treating prostate cancer.
PURPOSE: This randomized phase III trial is studying cyproterone acetate to compare how well it works when given continuously or after tumor progression in treating patients with newly diagnosed stage III or stage IV prostate cancer.
Detailed description
OBJECTIVES:
Primary
- Compare time to loss of androgen dependence, based on serum prostate-specific antigen failure, in patients with newly diagnosed stage III or IV prostate cancer treated with intermittent vs continuous androgen suppression comprising cyproterone acetate.
- Compare time to treatment failure (subjective or objective progression) in patients treated with these regimens.
- Compare quality of life of patients treated with these regimens.
- Compare survival of patients treated with these regimens.
Secondary
- Compare the side effects in patients treated with these regimens.
- Determine the first and total therapy-free intervals in patients treated with intermittent cyproterone acetate.
OUTLINE: This is a randomized, multicenter study.
All patients receive cyproterone acetate daily for 16 weeks. Patients also receive monthly injections of luteinizing hormone-releasing hormone (LHRH) agonist beginning in week 2 and continuing for 14 weeks. Patients with a prostate-specific antigen (PSA) level of ≤ 4 ng/mL and who are asymptomatic at 14 weeks are randomized to 1 of 2 treatment arms.
- Arm I (continuous maximum-androgen blockade): Patients receive cyproterone acetate daily and monthly LHRH agonist depot injections in the absence of disease progression or unacceptable toxicity. Patients may also undergo orchidectomy.
Quality of life is assessed every 6 months for 2 years and then annually thereafter.
- Arm II (intermittent treatment): Patients are observed after randomization. Treatment with daily cyproterone acetate resumes if symptoms demand hormone treatment and patient has any PSA level OR if patient is asymptomatic and has a PSA level ≥ 20 ng/mL. Treatment continues in the absence of disease progression or unacceptable toxicity. If after 9 months of treatment, a PSA level of ≤ 4 ng/mL is not achieved or the patient remains symptomatic, treatment is discontinued.
Quality of life is assessed every 6 months and when therapy is restarted.
Pain and performance status are assessed at each visit in both treatment arms.
After completion of study therapy, patients are followed periodically.
PROJECTED ACCRUAL: A total of 900 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- Up to 79 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 |
|---|---|---|
| gonadotrophin releasing hormone | Biological | – |
| cyproterone acetate | Drug | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Time to loss of androgen-dependence, based on serum prostate-specific antigen (PSA) failure according to protocol definition
Time to treatment failure (subjective or objective progression)
Quality of life
Survival
2 secondary outcomes
Side effects
First and total therapy-free intervals in patients treated with intermittent cyproterone acetate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
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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.
R. T. Oliver, MD study chair
St. Bartholomew's Hospital
2 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 gonadotrophin releasing hormone, cyproterone acetate and quality-of-life assessment in people with Prostate Cancer, run by St. Bartholomew's Hospital at 2 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: status not confirmed, as of the sponsor's last update on 26 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 2 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?
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?
Time to loss of androgen-dependence, based on serum prostate-specific antigen (PSA) failure according to protocol definition. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 26 Aug 2013.