Metastatic CancerPhase 2NCT00634582

Paricalcitol in Treating Patients With Advanced Prostate Cancer and Bone Metastases

A Phase 2 study testing paricalcitol, immunoenzyme technique and laboratory biomarker analysis in people with Metastatic Cancer and Prostate Cancer, run by Wake Forest University Health Sciences at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

RATIONALE: Paricalcitol may help prostate cancer cells become more like normal cells, and to grow and spread more slowly. It may also stop the growth of tumor cells in bone. PURPOSE: This phase II trial is studying how well paricalcitol works in treating patients with advanced prostate cancer and bone metastases. Read more about this study

Who is it for?: Ages 18 to 120 years, men only
Conditions the study is for: Metastatic Cancer, Prostate Cancer
What is being tested?: paricalcitol, immunoenzyme technique and laboratory biomarker analysis
Type of treatment: Surgery or procedure
How many people: 2 participants
Where: 1 siteUnited States
Study dates: Jan 2009to Jun 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

Histologically or cytologically confirmed advanced adenocarcinoma of the prostate
Radiographically proven bone metastasis from prostate cancer
Androgen refractory disease (including anti-androgen withdrawal)
Secondary hyperparathyroidism, defined as two parathyroid hormone (PTH) values > 70 pg/mL, 14 days apart
ECOG performance status 0-2
Leukocytes ≥ 3,000/μL

Show all 21Show fewer

Absolute neutrophil count ≥ 1,500/μL
Platelets ≥ 100,000/μL
Total bilirubin normal
AST/ALT ≤ 2.5 times upper limit of normal
Creatinine clearance ≥ 60 mL/min
Calcium normal
25-hydroxyvitamin D (25-OHD) ≥ 20 ng/mL
1,25(OH)_2D normal
Patients with serum 25-OHD indicative of vitamin D insufficiency are eligible provided they are treated with ergocalciferol to raise 25-OHD levels to 20 ng/mL prior to paricalcitol therapy
More than 8 weeks since prior bisphosphonates
More than 2 weeks since prior palliative radiotherapy
More than 4 weeks since other prior therapy
No more than one prior taxane-containing chemotherapy regimen for metastatic disease
Multiple lines of prior therapy with hormonal agents allowed
Concurrent corticosteroids allowed provided the dose remains stable during the study period

Who cannot join

Underlying metabolic bone disease or vitamin D deficiency
History of hypercalcemia
Concurrent uncontrolled illness or co-morbid condition (including psychiatric illness) that would interfere with study compliance
Concurrent ergocalciferol supplementation
Concurrent chemotherapy or hormonal therapy
Concurrent investigational or commercial agents for the malignancy

Trial locations and contacts

1 site in 1 country.

United States1 site

Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096

Other trials in United States

About this study

Official title: Phase II Trial of Zemplar (19-nor-1 a,25-Dihydroxyvitamin D2, Paricalcitol Capsule) on Bony Remodeling in Advanced Androgen-Insensitive Prostate Cancer

RATIONALE: Paricalcitol may help prostate cancer cells become more like normal cells, and to grow and spread more slowly. It may also stop the growth of tumor cells in bone.

PURPOSE: This phase II trial is studying how well paricalcitol works in treating patients with advanced prostate cancer and bone metastases.

Read the detailed description

OBJECTIVES:

Primary

To explore the relationship between paricalcitol therapy and markers of bone formation in patients with androgen-refractory, advanced prostate cancer with bone metastases.

Secondary

To explore the relationship between paricalcitol therapy and markers of bone resorption in these patients.

OUTLINE: Patients receive oral paricalcitol once daily for 10 weeks in the absence of unacceptable toxicity.

Patients undergo blood sample collection periodically to determine markers of bone formation and resorption by ELISA; parathyroid hormone (PTH) levels by immunometric assay; prostate-specific antigen (PSA) levels by immunoassay; and 25-hydroxyvitamin D and 1,25(OH)_2D levels by radioimmunoassay.

Patients also undergo a bone densitometry (DEXA scan) at baseline and at 10 weeks to assess changes in bone strength.

Quality of life is assessed prior to, during, and after completion of treatment. Questionnaires include the Pain Inventory, the Brief Pain Inventory, the Functional Assessment of Cancer Therapy-G (FACT-G), and the Analgesic Use Diary (Narcotic Pain Medication Logbook).

After completion of study treatment, patients are followed every 6 months for 1 year.

Conditions: Metastatic Cancer, Prostate Cancer
Being tested: paricalcitol, immunoenzyme technique, laboratory biomarker analysis, dual x-ray absorptometry, quality-of-life assessment
Keywords: adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer, bone metastases
Medical subject headings: Neoplasm Metastasis, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

paricalcitolDrug
immunoenzyme techniqueOther
laboratory biomarker analysisOther
dual x-ray absorptometryProcedure or surgery
quality-of-life assessmentProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

Biochemical Markers (i.e., Serum Parathyroid Hormone [PTH], Bone-specific Alkaline Phosphatase, and Osteocalcin) That Are Surrogates for Fracture Risk and Are Associated With Increased Bone Pain, Morbidity, and Mortality From Prostate Cancer
Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2009Jun 2015

First posted13 Mar 2008 (estimated)
Study startJan 2009
Primary completionJan 2013
Study completionJun 2015

Why it stopped: slow accrual

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Metastatic CancerStudies of the same condition, open and under way.
More trials run by Wake Forest University Health SciencesThe 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00634582
Sponsor's protocol ID: IRB00004564
Other IDs: P30CA012197, CCCWFU-85107
Status last verified: Jul 2018
First submitted: 12 Mar 2008
Last updated: 6 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Metastatic Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Trial of Zemplar (19-nor-1 a,25-Dihydroxyvitamin D2, Paricalcitol Capsule) on Bony Remodeling in Advanced Androgen-Insensitive Prostate Cancer
ClinicalTrials.gov ID: NCT00634582
Acronym / sponsor ID: IRB00004564
Conditions: Metastatic Cancer, Prostate Cancer
Keywords: adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer, bone metastases
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: slow accrual
Enrolment: 2 participants (actual)
Lead sponsor: Wake Forest University Health SciencesUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: Jan 2009
Primary completion: Jan 2013 (actual)
Study completion: Jun 2015 (actual)
First posted: 13 Mar 2008 (estimated)
Results: Posted 10 Jan 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

RATIONALE: Paricalcitol may help prostate cancer cells become more like normal cells, and to grow and spread more slowly. It may also stop the growth of tumor cells in bone.

PURPOSE: This phase II trial is studying how well paricalcitol works in treating patients with advanced prostate cancer and bone metastases.

Detailed description

OBJECTIVES:

Primary

To explore the relationship between paricalcitol therapy and markers of bone formation in patients with androgen-refractory, advanced prostate cancer with bone metastases.

Secondary

To explore the relationship between paricalcitol therapy and markers of bone resorption in these patients.

OUTLINE: Patients receive oral paricalcitol once daily for 10 weeks in the absence of unacceptable toxicity.

Patients also undergo a bone densitometry (DEXA scan) at baseline and at 10 weeks to assess changes in bone strength.

After completion of study treatment, patients are followed every 6 months for 1 year.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
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

Key inclusion criteria (21 listed)

Histologically or cytologically confirmed advanced adenocarcinoma of the prostate
Androgen refractory disease (including anti-androgen withdrawal)
Secondary hyperparathyroidism, defined as two parathyroid hormone (PTH) values > 70 pg/mL, 14 days apart
ECOG performance status 0-2
Leukocytes ≥ 3,000/μL

Key exclusion criteria (6 listed)

Underlying metabolic bone disease or vitamin D deficiency
History of hypercalcemia
Concurrent uncontrolled illness or co-morbid condition (including psychiatric illness) that would interfere with study compliance
Concurrent ergocalciferol supplementation
Concurrent chemotherapy or hormonal therapy

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
paricalcitol	Drug	–
immunoenzyme technique	Other	–
laboratory biomarker analysis	Other	–
dual x-ray absorptometry	Procedure or surgery	–
quality-of-life assessment	Procedure or surgery	–

Primary outcome

Biochemical Markers (i.e., Serum Parathyroid Hormone [PTH], Bone-specific Alkaline Phosphatase, and Osteocalcin) That Are Surrogates for Fracture Risk and Are Associated With Increased Bone Pain, Morbidity, and Mortality From Prostate Cancer
Time frame: 16 weeks

Results and safety

Results posted to the registry on 10 Jan 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Paricalcitol	2	2

Primary outcome: Biochemical Markers (i.e., Serum Parathyroid Hormone [PTH], Bone-specific Alkaline Phosphatase, and Osteocalcin) That Are Surrogates for Fracture Risk and Are Associated With Increased Bone Pain, Morbidity, and Mortality From Prostate Cancer

Time frame: 16 weeks

Population analysed: This trial was closed for slow accrual. For cost reasons, analysis was to be done in a batch size never reached, so the analysis was not done.

Adverse events

Time frame: 16 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Paricalcitol	1 of 2 (50%)	2 of 2 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Metastatic Cancer

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Enrolling by invitationPhase 2
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Pancreatic Cancer Metastatic
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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.

Gary G. Schwartz, MD, PhD, MPH study chair

Wake Forest University Health Sciences

Mebea Aklilu, MD principal investigator

Wake Forest University Health Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 21 inclusion and 6 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: stopped early, as of the sponsor's last update on 6 Jul 2018. 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?

Yes. Results are posted in the registry (first posted 10 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Biochemical Markers (i.e., Serum Parathyroid Hormone [PTH], Bone-specific Alkaline Phosphatase, and Osteocalcin) That Are Surrogates for Fracture Risk and Are Associated With Increased Bone Pain, Morbidity, and Mortality From Prostate Cancer (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00634582.

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 6 Jul 2018; AzTrials last refreshed its copy on 7 Nov 2026.