Prostate CancerPhase 2NCT00004043
Calcitriol in Treating Patients With a Rising PSA Level Following Treatment for Prostate Cancer
A Phase 2 study testing calcitriol in people with Prostate Cancer, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
RATIONALE: Calcitriol, a form of vitamin D, may be able to prevent or slow the growth of prostate cancer cells. PURPOSE: Phase II trial to study the effectiveness of calcitriol in treating patients who have a rising PSA level following previous treatment for prostate cancer. Read more about this study
- Who is it for?
- Ages 18 to 120 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- calcitriol
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 1999to Mar 2003
- 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 18 to 120 years
- Men only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically or cytologically proven adenocarcinoma of the prostate previously treated with prostatectomy or definitive radiotherapy Rising PSA after post definitive therapy nadir on at least 3 measurements at least 2 weeks apart PSA at least 0.4 ng/mL for prostatectomy patients PSA at least 1.0 ng/mL for radiotherapy patients
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Greater than 2 months Hematopoietic: Not specified Hepatic: Not specified Renal: Phosphate no greater than 4.2 mg/dL Creatinine no greater than 1.3 mg/dL Calcium no greater than 10.5 mg/dL No history of hypercalcemia Cardiovascular: No significant heart disease No myocardial infarction within past 3 months No history of heart failure Cardiac ejection fraction at least 30% Other: No other significant active medical illness that would preclude compliance Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior systemic chemotherapy for metastatic prostate cancer (except neoadjuvant treatment for localized prostate cancer) Endocrine therapy: No prior systemic hormonal therapy for prostate cancer (except neoadjuvant treatment for localized prostate cancer) Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics Other: No other concurrent systemic therapy for metastatic prostate cancer At least 30 days since other prior investigational drugs No concurrent digoxin At least 7 days since prior thiazide diuretic therapy No concurrent magnesium containing antacids, bile resin binding drugs, or calcium supplements
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: Phase II Study of Pulse Calcitriol in Patients With Rising PSA After Definitive Treatment for Prostate Cancer
RATIONALE: Calcitriol, a form of vitamin D, may be able to prevent or slow the growth of prostate cancer cells.
PURPOSE: Phase II trial to study the effectiveness of calcitriol in treating patients who have a rising PSA level following previous treatment for prostate cancer.
Read the detailed description
OBJECTIVES: I. Determine the response to pulse calcitriol in patients with previously treated adenocarcinoma of the prostate with rising PSA levels. II. Assess the impact of this regimen on the slope of the PSA rise in these patients. III. Determine the qualitative and quantitative toxic effects of this regimen in these patients. IV. Assess the impact of this regimen on the quality of life of these patients.
OUTLINE: All patients remain on a reduced calcium diet for the duration of the study. Twelve hours prior to treatment, patients begin drinking 4-6 glasses of extra fluid for 3 days. Patients receive oral calcitriol over 4 hours weekly. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every 4 weeks during treatment, and at the end of the study. Patients are followed for at least 1 month.
PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study.
- Conditions
- Prostate Cancer
- Being tested
- calcitriol
- Keywords
- adenocarcinoma of the prostate, recurrent 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.
calcitriolDietary supplement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2004 (estimated)
- Study startFeb 1999
- Primary completionMar 2003
- Study completionMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tom Beer, OHSU Knight Cancer Institute
- Investigators
- Tomasz Beer, MD, Study chair, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004043
- Sponsor's protocol ID
- CDR0000067041
- Other IDs
- OHSU-5231, OCC-HOR-98068-L, NCI-V99-1542
- Status last verified
- Apr 2017
- First submitted
- 10 Dec 1999
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lowe BA, Henner WD, Lemmon DD, et al.: Long term administration of high dose weekly oral calcitriol in patients with a rising PSA after definitive treatment for prostate cancer (PC): a phase II study. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-2446, 2002.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Pulse Calcitriol in Patients With Rising PSA After Definitive Treatment for Prostate Cancer
- ClinicalTrials.gov ID
- NCT00004043
- Acronym / sponsor ID
- CDR0000067041
- Conditions
- Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, recurrent prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Study start
- Feb 1999
- Primary completion
- Mar 2003 (actual)
- Study completion
- Mar 2003 (actual)
- First posted
- 17 Jun 2004 (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: Calcitriol, a form of vitamin D, may be able to prevent or slow the growth of prostate cancer cells.
PURPOSE: Phase II trial to study the effectiveness of calcitriol in treating patients who have a rising PSA level following previous treatment for prostate cancer.
Detailed description
OBJECTIVES: I. Determine the response to pulse calcitriol in patients with previously treated adenocarcinoma of the prostate with rising PSA levels. II. Assess the impact of this regimen on the slope of the PSA rise in these patients. III. Determine the qualitative and quantitative toxic effects of this regimen in these patients. IV. Assess the impact of this regimen on the quality of life of these patients.
OUTLINE: All patients remain on a reduced calcium diet for the duration of the study. Twelve hours prior to treatment, patients begin drinking 4-6 glasses of extra fluid for 3 days. Patients receive oral calcitriol over 4 hours weekly. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every 4 weeks during treatment, and at the end of the study. Patients are followed for at least 1 month.
PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 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 |
|---|---|---|
| calcitriol | Dietary supplement | – |
Primary outcome
Not reported in the source record.
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 28 Apr 2017.
- Results publicationLowe BA, Henner WD, Lemmon DD, et al.: Long term administration of high dose weekly oral calcitriol in patients with a rising PSA after definitive treatment for prostate cancer (PC): a phase II study. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-2446, 2002.
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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.
Tomasz Beer, MD study chair
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing calcitriol in people with Prostate Cancer, run by OHSU Knight Cancer Institute 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 28 Apr 2017. 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00004043, which also lists 1 linked publication.
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 28 Apr 2017.