Prostate CancerNCT00228124
PR.7 Companion Trial: Effect of Intermittent Versus Continuous Androgen Suppression on Bone Loss and Body Composition
An observational study of Prostate Cancer, run by Ontario Cancer Research Network at 1 site in Canada.
Trial summary
The purpose of this study is to determine, in patients entered on the National Cancer Institute of Canada (NCIC)-PR.7 trial of intermittent versus continuous androgen ablation, whether the rates of osteoporosis, fractures, and alteration in body composition are reduced by intermittent androgen ablation. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Prostate Cancer
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2004to Apr 2008
- Phase
- Observational
- 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically confirmed PCa
- Completed radiotherapy to the prostatic area more than 12 months prior to randomization
- Rising PSA level (serum PSA > 3 ng/ml (3 μg/L)) and higher than the lowest level recorded previously since the end of radiotherapy (i.e. higher than the post-radiotherapy nadir)
- No definite evidence of distant metastasis (radiological changes compatible with non-malignant diseases are acceptable)
- No prior hormonal therapy with the exception of neo-adjuvant cytoreduction prior to radical radiotherapy or prostatectomy for a maximum duration of 12 months and completed at least 12 months prior to randomization.
Who cannot join
- Severe osteoporosis
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook and Women's College Health Sciences Centre
Toronto, Ontario, M4N 3M5
Marlene Kebabdjian, CRA, 416-480-6100 ext. 2890, marlene.kebabdjian@sw.ca
About this study
Official title: Effect of Intermittent Versus Continuous Androgen Suppression on Bone Loss and Body Composition in a Phase III Randomized Trial
The purpose of this study is to determine, in patients entered on the National Cancer Institute of Canada (NCIC)-PR.7 trial of intermittent versus continuous androgen ablation, whether the rates of osteoporosis, fractures, and alteration in body composition are reduced by intermittent androgen ablation.
There will be two groups of patients:
- A cross-sectional group of 150 patients registered in PR.7 prior to January 1, 2002, randomized between intermittent androgen suppression (IAS) and continuous androgen suppression (CAS) (75 from each group). Patients who have definite bone metastases are excluded from this study. Biochemical failure does not exclude the patient.
- A longitudinal study of 150 newly accrued patients randomized between IAS and CAS (75 from each group). These patients will have baseline evaluation of bone loss and body composition, longitudinal monitoring and follow-up on an annual basis for patients on CAS and at the end of each "off cycle" of IAS. Patients taking bisphosphonates are excluded from this study.
Read the detailed description
Primary Objectives:
- To compare CAS and IAS with respect to bone mineral density (BMD): We will determine whether the bone loss associated with long term CAS can be reduced by IAS by evaluation of:
- BMD,
- biochemical markers of bone formation/resorption,
- skeletal relevant events (SRE) (defined as pathological fracture, symptomatic hypercalcemia or hypocalcemia, spinal cord compression, or need of spinal orthosis for vertebral deformity or collapse).
- To compare CAS and IAS with respect to body composition: We will determine whether the reduction in muscle mass and increased fat accumulation associated with long term CAS can be reduced by IAS. We will evaluate:
- percentage fat body mass,
- percentage lean body mass and
- body mass index.
- To evaluate the predictive value of germline polymorphisms in the Vitamin D receptor (VDR) gene for bone loss
Eligible Patients for PR.7:
- Histologically confirmed prostate cancer (PCa)
- Completed radiotherapy to the prostatic area more than 12 months prior to randomization
- Rising prostate specific antigen (PSA) level (serum PSA > 3 ng/ml (3 μg/L)) and higher than the lowest level recorded previously since the end of radiotherapy (i.e. higher than the post-radiotherapy nadir)
- No definite evidence of distant metastasis (radiological changes compatible with non-malignant diseases are acceptable)
- No prior hormonal therapy with the exception of neo-adjuvant cytoreduction prior to radical radiotherapy or prostatectomy for a maximum duration of 12 months and completed at least 12 months prior to randomization
Evaluation during protocol treatment will take place to assess differences in BMD, body composition, biochemical and genetic markers of bone disease in the two groups.
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Continuous androgen suppression, Intermittent androgen suppression, Bone loss, Osteoporosis
- Medical subject headings
- Prostatic Neoplasms, Bone Diseases, Metabolic, Osteoporosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2005 (estimated)
- Study startApr 2004
- Study completionApr 2008
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
- Observational
- Time perspective
- Other
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Ontario Cancer Research Network
- Sponsor type
- Research network
- Investigators
- Laurence Klotz, MD, FRCSC, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00228124
- Sponsor's protocol ID
- 02-OCT-0203
- Other IDs
- 02-OCT-0203
- Status last verified
- Sep 2005
- First submitted
- 27 Sep 2005
- Last updated
- 26 Jan 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intermittent Versus Continuous Androgen Suppression on Bone Loss and Body Composition in a Phase III Randomized Trial
- ClinicalTrials.gov ID
- NCT00228124
- Acronym / sponsor ID
- 02-OCT-0203
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Continuous androgen suppression, Intermittent androgen suppression, Bone loss, Osteoporosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants
- Lead sponsor
- Ontario Cancer Research NetworkResearch network
- Study start
- Apr 2004
- Study completion
- Apr 2008
- First posted
- 28 Sep 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.
The purpose of this study is to determine, in patients entered on the National Cancer Institute of Canada (NCIC)-PR.7 trial of intermittent versus continuous androgen ablation, whether the rates of osteoporosis, fractures, and alteration in body composition are reduced by intermittent androgen ablation.
There will be two groups of patients:
- A cross-sectional group of 150 patients registered in PR.7 prior to January 1, 2002, randomized between intermittent androgen suppression (IAS) and continuous androgen suppression (CAS) (75 from each group). Patients who have definite bone metastases are excluded from this study. Biochemical failure does not exclude the patient.
- A longitudinal study of 150 newly accrued patients randomized between IAS and CAS (75 from each group). These patients will have baseline evaluation of bone loss and body composition, longitudinal monitoring and follow-up on an annual basis for patients on CAS and at the end of each "off cycle" of IAS. Patients taking bisphosphonates are excluded from this study.
Detailed description
Primary Objectives:
- To compare CAS and IAS with respect to bone mineral density (BMD): We will determine whether the bone loss associated with long term CAS can be reduced by IAS by evaluation of:
- BMD,
- biochemical markers of bone formation/resorption,
- skeletal relevant events (SRE) (defined as pathological fracture, symptomatic hypercalcemia or hypocalcemia, spinal cord compression, or need of spinal orthosis for vertebral deformity or collapse).
- To compare CAS and IAS with respect to body composition: We will determine whether the reduction in muscle mass and increased fat accumulation associated with long term CAS can be reduced by IAS. We will evaluate:
- percentage fat body mass,
- percentage lean body mass and
- body mass index.
- To evaluate the predictive value of germline polymorphisms in the Vitamin D receptor (VDR) gene for bone loss
Eligible Patients for PR.7:
- Histologically confirmed prostate cancer (PCa)
- Completed radiotherapy to the prostatic area more than 12 months prior to randomization
- Rising prostate specific antigen (PSA) level (serum PSA > 3 ng/ml (3 μg/L)) and higher than the lowest level recorded previously since the end of radiotherapy (i.e. higher than the post-radiotherapy nadir)
- No definite evidence of distant metastasis (radiological changes compatible with non-malignant diseases are acceptable)
- No prior hormonal therapy with the exception of neo-adjuvant cytoreduction prior to radical radiotherapy or prostatectomy for a maximum duration of 12 months and completed at least 12 months prior to randomization
Evaluation during protocol treatment will take place to assess differences in BMD, body composition, biochemical and genetic markers of bone disease in the two groups.
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically confirmed PCa
- Completed radiotherapy to the prostatic area more than 12 months prior to randomization
- Rising PSA level (serum PSA > 3 ng/ml (3 μg/L)) and higher than the lowest level recorded previously since the end of radiotherapy (i.e. higher than the post-radiotherapy nadir)
- No definite evidence of distant metastasis (radiological changes compatible with non-malignant diseases are acceptable)
- No prior hormonal therapy with the exception of neo-adjuvant cytoreduction prior to radical radiotherapy or prostatectomy for a maximum duration of 12 months and completed at least 12 months prior to randomization.
Key exclusion criteria (1 listed)
- Severe osteoporosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2006.
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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.
Laurence Klotz, MD, FRCSC principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Ontario Cancer Research Network at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. 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 Jan 2006. 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 Canada. 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.
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?
Contact Laurence Klotz, MD, FRCSC (416-480-4673, laurence.klotz@sw.ca), or a site near the patient. 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 26 Jan 2006.