Prostate CancerPhase 2NCT00084864

Calcitriol and Dexamethasone Before Radical Prostatectomy in Treating Patients With Localized Adenocarcinoma (Cancer) of the Prostate

A Phase 2 study testing calcitriol, dexamethasone and clinical observation in people with Prostate Cancer, run by Roswell Park Cancer Institute 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: Calcitriol and dexamethasone may slow the growth of prostate cancer cells. PURPOSE: This randomized phase II trial is studying how well giving calcitriol together with dexamethasone before radical prostatectomy works in treating patients with localized stage II or stage III adenocarcinoma (cancer) of the… 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, dexamethasone and clinical observation
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteUnited States
Study dates: Sep 2002to May 2010
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

DISEASE CHARACTERISTICS:

Histologically confirmed adenocarcinoma of the prostate
Organ-confined disease
cT1, cT2, or cT3 tumors
Patients with cT1 tumors are eligible if ≥ 1 core biopsies have ≥ 50% of the tumor OR if 50% of the cores examined contain the tumor
No small cell carcinoma of the prostate
Scheduled for radical prostatectomy

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Platelet count ≥ 100,000/mm^3
WBC ≥ 3,500/mm^3

Hepatic

ALT and AST ≤ 4 times normal
Bilirubin ≤ 2 mg/dL

Renal

Creatinine ≤ 2 times upper limit of normal
Calcium ≤ 10.5 mg/dL
No detectable renal stones by CT scan or ultrasound

Other

No history of diabetes mellitus requiring pharmacotherapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

More than 5 years since prior antiestrogens, antiandrogens, luteinizing hormone-releasing hormone agonists, estrogen, or progestational agents

Radiotherapy

Not specified

Surgery

See Disease Characteristics
No prior nephrectomy
No prior prostatic surgery
No prior cryotherapy or transurethral resection of the prostate

Trial locations and contacts

1 site in 1 country.

United States1 site

Roswell Park Cancer Institute
Buffalo, New York, 14263-0001

Other trials in United States

About this study

Official title: A Pilot Trial of Calcitriol in Localized Prostate Cancer: Investigation of Biologic Effects and Potential Intermediate Endpoints

RATIONALE: Calcitriol and dexamethasone may slow the growth of prostate cancer cells.

PURPOSE: This randomized phase II trial is studying how well giving calcitriol together with dexamethasone before radical prostatectomy works in treating patients with localized stage II or stage III adenocarcinoma (cancer) of the prostate.

Read the detailed description

OBJECTIVES:

Determine the effect of calcitriol and dexamethasone before radical prostatectomy on tumor vessel density in patients with localized adenocarcinoma of the prostate.
Determine the effect of this regimen on the extent of prostatic intraepithelial neoplasia in these patients.
Determine the effect of this regimen on the expression of apoptosis markers, p21, p27, prostate-specific antigen (PSA), prostate-specific membrane antigen, and VDR expression in tumor-associated vascular endothelial cells and endothelium derived from normal-appearing prostate and tumor in these patients.
Determine the acute effects of this regimen on serum PSA in these patients.
Determine the toxicity of this regimen in these patients.

OUTLINE: This is a two-stage, randomized, pilot study.

Stage 1: Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery. Within 48 hours of the last dose, patients undergo radical prostatectomy.
Arm II: Patients receive no study drugs, but undergo radical prostatectomy.
Stage 2: If sufficient activity is seen with the dexamethasone and calcitriol regimen in stage 1, the study is expanded and additional patients are randomized to 1 of 4 treatment arms.
Arm I: Patients receive dexamethasone and calcitriol as in stage 1, arm I.
Arm II: Patients receive oral dexamethasone once daily on days 1-4.
Arm III: Patients receive oral calcitriol once daily on days 2-4.
Arm IV: Patients undergo radical prostatectomy as in stage 1, arm II. In arms I, II, and III, patients undergo radical prostatectomy as in stage 1, arm I.

Patients are followed at 1, 3, and 12 months.

PROJECTED ACCRUAL: A total of 20-80 patients (20 for stage 1 [10 per treatment arm] and 60 for stage 2) will be accrued for this study within 2 years.

Conditions: Prostate Cancer
Being tested: calcitriol, dexamethasone, clinical observation
Keywords: adenocarcinoma of the prostate, stage II prostate cancer, stage III 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
Given orally
dexamethasoneDrug
Given orally
clinical observationOther
No intervention before surgery

Study groups in NCT00084864
Study group	Role	What they receive
Stage 1, Arm I	Experimental	Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery. Receives: Dietary Supplement: calcitriol; Drug: dexamethasone
Stage 1, Arm II	Experimental	No study drugs before surgery. Receives: Other: clinical observation
Stage 1 Arm 3	Experimental	Patients receive oral dexamethasone once daily on days 1-4. Receives: Drug: dexamethasone
Stage 1, Arm 4	Experimental	Patients receive oral calcitriol once daily on days 2-4. Receives: Dietary Supplement: calcitriol

What is being measured

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

Effect of Preoperative High-dose Calcitriol and Dexamethasone on Prostatic Tumor Vessel Density Measured at 1, 2, 3, and 12 Months Post Prostatectomy
Measured: Up to 30 days of the last administration of study procedure

Secondary outcomes (4)

Effect of Preoperative High-dose Calcitriol and Dexamethasone on Extent of Prostatic Intraepithelial Neoplasia (PIN) at 1, 2, 3, and 12 Months Post Prostatectomy
Measured: Up to 30 days of the last administration of study procedure
Determine the Effect of This Regimen on the Expression of Apoptosis Markers
Determine the effect of this regimen on the expression of apoptosis markers, p21, p27, prostate-specific antigen (PSA), prostate-specific membrane antigen, and VDR expression in tumor-associated vascular endothelial cells and endothelium derived from normal-appearing prostate and tumor in these patients.
Measured: Up to 30 days of the last administration of study procedure
Determine the Acute Effects of This Regimen on Serum PSA in These Patients.
Measured: Up to 30 days of the last administration of study procedure
Number of Participants With Adverse Events, Graded According to NCI CTCAE v2.0
Number of Participants with Adverse Events, Graded According to NCI CTCAE v2.0
Measured: Up to 30 days of the last administration of study procedure

Timeline

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

Sep 2002May 2010

First posted11 Jun 2004 (estimated)
Study startSep 2002
Primary completionFeb 2010
Study completionMay 2010

Why it stopped: sample size is too small to draw a conclusion

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 Prostate CancerStudies of the same condition, open and under way.
More trials run by Roswell Park 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: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00084864
Sponsor's protocol ID: RP 02-12
Other IDs: P30CA016056, RPCI-RP-0212
Status last verified: May 2017
First submitted: 10 Jun 2004
Last updated: 12 Jun 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Trial of Calcitriol in Localized Prostate Cancer: Investigation of Biologic Effects and Potential Intermediate Endpoints
ClinicalTrials.gov ID: NCT00084864
Acronym / sponsor ID: RP 02-12
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate, stage II prostate cancer, stage III prostate cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: sample size is too small to draw a conclusion
Enrolment: 25 participants (actual)
Lead sponsor: Roswell Park Cancer InstituteUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: Sep 2002
Primary completion: Feb 2010 (actual)
Study completion: May 2010 (actual)
First posted: 11 Jun 2004 (estimated)
Results: Posted 12 Jun 2017

Clinical summary

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

RATIONALE: Calcitriol and dexamethasone may slow the growth of prostate cancer cells.

Detailed description

OBJECTIVES:

Determine the effect of calcitriol and dexamethasone before radical prostatectomy on tumor vessel density in patients with localized adenocarcinoma of the prostate.
Determine the effect of this regimen on the extent of prostatic intraepithelial neoplasia in these patients.
Determine the effect of this regimen on the expression of apoptosis markers, p21, p27, prostate-specific antigen (PSA), prostate-specific membrane antigen, and VDR expression in tumor-associated vascular endothelial cells and endothelium derived from normal-appearing prostate and tumor in these patients.
Determine the acute effects of this regimen on serum PSA in these patients.
Determine the toxicity of this regimen in these patients.

OUTLINE: This is a two-stage, randomized, pilot study.

Stage 1: Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery. Within 48 hours of the last dose, patients undergo radical prostatectomy.
Arm II: Patients receive no study drugs, but undergo radical prostatectomy.
Stage 2: If sufficient activity is seen with the dexamethasone and calcitriol regimen in stage 1, the study is expanded and additional patients are randomized to 1 of 4 treatment arms.
Arm I: Patients receive dexamethasone and calcitriol as in stage 1, arm I.
Arm II: Patients receive oral dexamethasone once daily on days 1-4.
Arm III: Patients receive oral calcitriol once daily on days 2-4.
Arm IV: Patients undergo radical prostatectomy as in stage 1, arm II. In arms I, II, and III, patients undergo radical prostatectomy as in stage 1, arm I.

Patients are followed at 1, 3, and 12 months.

PROJECTED ACCRUAL: A total of 20-80 patients (20 for stage 1 [10 per treatment arm] and 60 for stage 2) will be accrued for this study within 2 years.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Stage 1, Arm I	Experimental	Dietary Supplement: calcitriol, Drug: dexamethasonePatients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery.
Stage 1, Arm II	Experimental	Other: clinical observationNo study drugs before surgery.
Stage 1 Arm 3	Experimental	Drug: dexamethasonePatients receive oral dexamethasone once daily on days 1-4.
Stage 1, Arm 4	Experimental	Dietary Supplement: calcitriolPatients receive oral calcitriol once daily on days 2-4.

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
calcitriolGiven orally	Dietary supplement	Stage 1, Arm 4, Stage 1, Arm I
dexamethasoneGiven orally	Drug	Stage 1 Arm 3, Stage 1, Arm I
clinical observationNo intervention before surgery	Other	Stage 1, Arm II

Primary outcome

Effect of Preoperative High-dose Calcitriol and Dexamethasone on Prostatic Tumor Vessel Density Measured at 1, 2, 3, and 12 Months Post Prostatectomy
Time frame: Up to 30 days of the last administration of study procedure

4 secondary outcomes

Effect of Preoperative High-dose Calcitriol and Dexamethasone on Extent of Prostatic Intraepithelial Neoplasia (PIN) at 1, 2, 3, and 12 Months Post Prostatectomy
Time frame: Up to 30 days of the last administration of study procedure
Determine the Effect of This Regimen on the Expression of Apoptosis Markers
Time frame: Up to 30 days of the last administration of study procedure
Determine the Acute Effects of This Regimen on Serum PSA in These Patients.
Time frame: Up to 30 days of the last administration of study procedure
Number of Participants With Adverse Events, Graded According to NCI CTCAE v2.0
Time frame: Up to 30 days of the last administration of study procedure

Results and safety

Results posted to the registry on 12 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1	10	9
Arm 2	7	7
Arm 3	4	4
Arm 4	4	4

Primary outcome: Effect of Preoperative High-dose Calcitriol and Dexamethasone on Prostatic Tumor Vessel Density Measured at 1, 2, 3, and 12 Months Post Prostatectomy

Time frame: Up to 30 days of the last administration of study procedure

Population analysed: Study was activated in 9/2002 which was prior to Roswell Park Cancer Institute (RPCI) putting a system in place to centralize data entry and data management. Data entry of the outcomes was done by PI's staff and has since been lost. All attempts to retrieve the data have failed.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1	0 of 10 (0%)	5 of 10 (50%)	Not reported
Arm 2	1 of 7 (14.3%)	4 of 7 (57.1%)	Not reported
Arm 3	0 of 4 (0%)	3 of 4 (75%)	Not reported
Arm 4	0 of 4 (0%)	2 of 4 (50%)	Not reported

Limitations and caveats (from the sponsor): Study was activated prior to Roswell Park Cancer Institute (RPCI) putting a system in place to centralize data entry and data management. Data entry was done by PI's staff. PI left institute and left incomplete data.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Donald L. Trump, MD principal investigator

Roswell Park 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, dexamethasone and clinical observation in people with Prostate Cancer, run by Roswell Park 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: stopped early, as of the sponsor's last update on 12 Jun 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?

Yes. Results are posted in the registry (first posted 12 Jun 2017). 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?

Effect of Preoperative High-dose Calcitriol and Dexamethasone on Prostatic Tumor Vessel Density Measured at 1, 2, 3, and 12 Months Post Prostatectomy (time frame: Up to 30 days of the last administration of study procedure). 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 NCT00084864.

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 Jun 2017.