Prostate CancerPhase 2NCT00022412
Doxercalciferol Before Surgery in Treating Localized Prostate Cancer
A Phase 2 study testing doxercalciferol and conventional surgery in people with Prostate Cancer, run by University of Wisconsin, Madison at 6 sites in United States.
Trial summary
RATIONALE: Doxercalciferol may be an effective way to treat localized prostate cancer before surgery. PURPOSE: Randomized phase II trial to study the effectiveness of giving doxercalciferol before surgery in treating patients who have localized prostate cancer. Read more about this study
- Who is it for?
- Ages 21 to 120 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- doxercalciferol and conventional surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 6 sitesUnited States
- Study dates
- Aug 2001to Aug 2008
- 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 21 to 120 years
- Men only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed localized adenocarcinoma of the prostate
- Candidate for prostatectomy
PATIENT CHARACTERISTICS:
Age:
- 21 and over
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 4,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.4 mg/dL
- AST no greater than 3 times normal
Renal:
- Creatinine no greater than 2.0 mg/dL
- Calcium no greater than 10.2 mg/dL
- No idiopathic urinary calcium stone disease
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- No prior hormonal therapy for prostate cancer
- No concurrent hormonal therapy, including luteinizing hormone-releasing hormone agonists, antiandrogens, glucocorticoids, ketoconazole, finasteride, diethylstilbestrol, or progestins
Radiotherapy:
- No prior brachytherapy or external beam radiotherapy for prostate cancer
Surgery:
- See Disease Characteristics
Other:
- At least 7 days since prior vitamin D therapy or calcium supplements
- No other concurrent vitamin D analogues or calcium supplements
- No concurrent magnesium-containing antacids
- No concurrent thiazide-containing diuretics
- No concurrent phenytoin, phenobarbital, glutethimide, digoxin, or digitalis
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, 52242-1002
Veterans Affairs Medical Center - Madison
Madison, Wisconsin, 53705
Meriter Hospital
Madison, Wisconsin, 53715
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, 53226-3596
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Phase II Open Label, Multi-Center Clinical Trial Of Modulation Of Intermediate Endpoint Biomarkers By 1x-Hydroxyvitamin D2 In Patients With Clinically Localized Prostate Cancer And High Grade PIN
RATIONALE: Doxercalciferol may be an effective way to treat localized prostate cancer before surgery.
PURPOSE: Randomized phase II trial to study the effectiveness of giving doxercalciferol before surgery in treating patients who have localized prostate cancer.
Read the detailed description
OBJECTIVES:
- Determine whether doxercalciferol modulates intermediate endpoint biomarkers in the development of prostate cancer in patients with localized prostate cancer.
- Assess the toxicity of this drug in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to one of 2 arms.
- Arm I: Patients receive doxercalciferol once daily for 28 days. Patients then undergo prostatectomy.
- Arm II: Patients undergo observation for 28 days. Patients then undergo prostatectomy.
PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study within 18 months.
- Conditions
- Prostate Cancer
- Being tested
- doxercalciferol, conventional surgery
- Keywords
- adenocarcinoma of the prostate, stage I prostate cancer, stage II 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.
doxercalciferolDietary supplement
Also called Localized adenocarcinoma of the prostate
Arm 1: Patients receive doxercalciferol once daily for 28 days. Patients then undergo prostatectomy.
conventional surgeryProcedure or surgery
Also called Prostatectomy - no dietary supplement
Procedure: Prostatectomy for prostate cancer
| Study group | Role | What they receive |
|---|---|---|
| Observation, then prostatectomy | Placebo comparator | Arm 2: Patients undergo observation for 28 days. Patients then undergo prostatectomy. Receives: Procedure: conventional surgery |
| Doxercalciferol once daily for 28 days | Active comparator | Dietary supplement once daily to treat prostate cancer for 28 days Receives: Dietary Supplement: doxercalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intermediate endpoint biomarker modulation
Measured: 18 months
Toxicity
Measured: 30 months
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 startAug 2001
- Primary completionFeb 2006
- Study completionAug 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.
- More trials run by University of Wisconsin, MadisonThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- George Wilding, MD, Study chair, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00022412
- Sponsor's protocol ID
- CO99802
- Other IDs
- P30CA014520, WCCC-CO-99802, NCI-N01-CN-95130, WCCC-CO-2000169, NCI-P01-0188, CDR0000068813, 2000-595
- Status last verified
- Oct 2016
- First submitted
- 10 Aug 2001
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Open Label, Multi-Center Clinical Trial Of Modulation Of Intermediate Endpoint Biomarkers By 1x-Hydroxyvitamin D2 In Patients With Clinically Localized Prostate Cancer And High Grade PIN
- ClinicalTrials.gov ID
- NCT00022412
- Acronym / sponsor ID
- CO99802
- Conditions
- Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, stage I prostate cancer, stage II prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2001
- Primary completion
- Feb 2006 (actual)
- Study completion
- Aug 2008 (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: Doxercalciferol may be an effective way to treat localized prostate cancer before surgery.
PURPOSE: Randomized phase II trial to study the effectiveness of giving doxercalciferol before surgery in treating patients who have localized prostate cancer.
Detailed description
OBJECTIVES:
- Determine whether doxercalciferol modulates intermediate endpoint biomarkers in the development of prostate cancer in patients with localized prostate cancer.
- Assess the toxicity of this drug in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to one of 2 arms.
- Arm I: Patients receive doxercalciferol once daily for 28 days. Patients then undergo prostatectomy.
- Arm II: Patients undergo observation for 28 days. Patients then undergo prostatectomy.
PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study within 18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observation, then prostatectomy | Placebo comparator | Procedure: conventional surgeryArm 2: Patients undergo observation for 28 days. Patients then undergo prostatectomy. |
| Doxercalciferol once daily for 28 days | Active comparator | Dietary Supplement: doxercalciferolDietary supplement once daily to treat prostate cancer for 28 days |
Who may qualify
- Ages
- 21 to 120 years
- 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 |
|---|---|---|
| doxercalciferolAlso: Localized adenocarcinoma of the prostateArm 1: Patients receive doxercalciferol once daily for 28 days. Patients then undergo prostatectomy. | Dietary supplement | Doxercalciferol once daily for 28 days |
| conventional surgeryAlso: Prostatectomy - no dietary supplementProcedure: Prostatectomy for prostate cancer | Procedure or surgery | Observation, then prostatectomy |
Primary outcome
Intermediate endpoint biomarker modulation
Time frame: 18 months
Toxicity
Time frame: 30 months
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 13 Dec 2019.
- University of Wisconsin Carbone Cancer CenterLink 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.
George Wilding, MD study chair
University of Wisconsin, Madison
6 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 doxercalciferol and conventional surgery in people with Prostate Cancer, run by University of Wisconsin, Madison at 6 sites 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 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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. Some participants in this study may receive a placebo. 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.
What does the primary outcome measure?
Intermediate endpoint biomarker modulation (time frame: 18 months). 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 13 Dec 2019.