OsteoporosisNCT00176579
Bone Mineral Density and Cancer Recurrence in Patients With Early Stage Prostate Cancer
An observational study of Osteoporosis and Prostate Cancer, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
Trial summary
RATIONALE: Measuring bone mineral density may help doctors predict whether prostate cancer will come back. It may also help the study of prostate cancer in the future. PURPOSE: This clinical trial is studying whether bone mineral density affects cancer recurrence in patients with early stage prostate cancer. Read more about this study
- Who is it for?
- Ages 50 to 75 years, men only
- Conditions the study is for
- Osteoporosis, Prostate Cancer
- What is being tested?
- dual x-ray absorptiometry
- Type of treatment
- Surgery or procedure
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to Jul 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 50 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be recruited from urologists' offices and the oncological practices of CINJ. This will be done by verbal communication through the office staff and with the distribution of a brochure briefly describing the study. If a person is interested, he will be given information that briefly describes the study and his name will be taken down. A research assistant will call him and set up a meeting, preferably at the same time he is scheduled to see his physician. At that meeting, a research assistant will go over the consent form with him and cover all questions concerning the study. Eligibility (based on history) will also be verified at this meeting. If he wishes to participate, he will be instructed to sign the consent and an appointment for the blood tests and DXA scan will be arranged.
DISEASE CHARACTERISTICS:
- Biopsy-confirmed early stage prostate cancer
- Disease localized within the capsule
- No evidence of regional or distant spread (i.e., T1-2, N0, M0 disease)
- A cohort of patients must have undergone a prior radical prostatectomy
- Prostate specific antigen < 12 ng/mL
- Gleason score ≥ 6
PATIENT CHARACTERISTICS:
- Creatinine clearance ≤ 2.0 mg/dL
- No Paget's disease
- No hyperthyroidism or hypothyroidism
- No Cushing's disease
- No chronic liver disease
- No major health problems that would cause a significant reduction in mobility or activities of daily living
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior bisphosphonates, thyroxin, or calcitonin
- No prior agents that suppress PSA levels (e.g., finasteride)
- No prior androgen or estrogen therapy
- More than 12 months since prior glucocorticoids
- More than 12 months since prior herbal supplements that are known to lower PSA levels
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
About this study
Official title: Assessing Bone Mineral Density as a Risk Factor for Early Clinically Significant Prostate Cancer
RATIONALE: Measuring bone mineral density may help doctors predict whether prostate cancer will come back. It may also help the study of prostate cancer in the future.
PURPOSE: This clinical trial is studying whether bone mineral density affects cancer recurrence in patients with early stage prostate cancer.
Read the detailed description
OBJECTIVES:
- Determine bone mineral density (BMD) in patients with clinically significant early stage prostate cancer.
- Determine whether patients who have a higher level of BMD and have had a radical prostatectomy for cure are less likely to have an early relapse (i.e., less than 3 years) than those patients with a low level of BMD.
OUTLINE: This is a case-controlled study followed by a prospective, longitudinal, cohort study.
Patients undergo bone mineral density (BMD) measurements by dual-energy x-ray absorptiometry with a densitometer. Posteroanterior measurements of the total hip are also recorded.
Patients also undergo blood collection to examine markers that provide evidence of systemic disease.
Patients are followed every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
- Conditions
- Osteoporosis, Prostate Cancer
- Being tested
- dual x-ray absorptiometry
- Keywords
- osteoporosis, stage I prostate cancer
- Medical subject headings
- Osteoporosis, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dual x-ray absorptiometryProcedure or surgery
Dual x-ray absortiometry by densitometer will be performed to measure bone mineral density
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density
DXA scan will be done after patient signs consent and eligibilty is confirmed
Measured: Baseline
Prostate Specific Antigen
PSA will be measured to look for biochemical recurrence of prostate cancer
Measured: Baseline, every 6 months for 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJun 2003
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Dentistry of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Stephen W. Marcella, MD, MPH, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00176579
- Sponsor's protocol ID
- CDR0000539677
- Other IDs
- P30CA072720, CINJ-5004, CINJ-4375
- Status last verified
- Aug 2011
- First submitted
- 13 Sep 2005
- Last updated
- 12 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Bone Mineral Density as a Risk Factor for Early Clinically Significant Prostate Cancer
- ClinicalTrials.gov ID
- NCT00176579
- Acronym / sponsor ID
- CDR0000539677
- Conditions
- Osteoporosis, Prostate Cancer
- Keywords
- osteoporosis, stage I prostate cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of Medicine and Dentistry of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2003
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 15 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.
RATIONALE: Measuring bone mineral density may help doctors predict whether prostate cancer will come back. It may also help the study of prostate cancer in the future.
PURPOSE: This clinical trial is studying whether bone mineral density affects cancer recurrence in patients with early stage prostate cancer.
Detailed description
OBJECTIVES:
- Determine bone mineral density (BMD) in patients with clinically significant early stage prostate cancer.
- Determine whether patients who have a higher level of BMD and have had a radical prostatectomy for cure are less likely to have an early relapse (i.e., less than 3 years) than those patients with a low level of BMD.
OUTLINE: This is a case-controlled study followed by a prospective, longitudinal, cohort study.
Patients undergo bone mineral density (BMD) measurements by dual-energy x-ray absorptiometry with a densitometer. Posteroanterior measurements of the total hip are also recorded.
Patients also undergo blood collection to examine markers that provide evidence of systemic disease.
Patients are followed every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited from urologists' offices and the oncological practices of CINJ. This will be done by verbal communication through the office staff and with the distribution of a brochure briefly describing the study. If a person is interested, he will be given information that briefly describes the study and his name will be taken down. A research assistant will call him and set up a meeting, preferably at the same time he is scheduled to see his physician. At that meeting, a research assistant will go over the consent form with him and cover all questions concerning the study. Eligibility (based on history) will also be verified at this meeting. If he wishes to participate, he will be instructed to sign the consent and an appointment for the blood tests and DXA scan will be arranged.
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 |
|---|---|---|
| dual x-ray absorptiometryDual x-ray absortiometry by densitometer will be performed to measure bone mineral density | Procedure or surgery | – |
Primary outcome
Bone mineral density
Time frame: Baseline
DXA scan will be done after patient signs consent and eligibilty is confirmed
Prostate Specific Antigen
Time frame: Baseline, every 6 months for 3 years
PSA will be measured to look for biochemical recurrence of prostate cancer
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 12 Aug 2011.
- Clinical trial summary from Clinicaltrials.gov websiteLink provided by the sponsor.
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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.
Stephen W. Marcella, MD, MPH principal investigator
Rutgers Cancer Institute of New Jersey
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 Osteoporosis and Prostate Cancer, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
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 12 Aug 2011. 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 United States. 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?
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?
Bone mineral density (time frame: Baseline). The study lists 2 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 12 Aug 2011.