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Prostate CancerPhase 2NCT00054522

Calcitriol and Dexamethasone in Treating Patients With Prostate Cancer Who Have Undergone Surgery or Radiation Therapy

A Phase 2 study testing calcitriol and dexamethasone in people with Prostate Cancer, run by Roswell Park Cancer Institute at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Calcitriol may help tumor cells develop into normal cells. Dexamethasone may increase the effectiveness of calcitriol by making tumor cells more sensitive to the drug. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
calcitriol and dexamethasone
How many people
15 participants
Where
2 sitesUnited States
Study dates
Apr 2002to Mar 2006
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 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate meeting all of the following criteria:
  • Curatively treated with radical prostatectomy OR definitive radiotherapy
  • No signs of clinical recurrence or dissemination of prostate cancer by digital rectal examination without tumor
  • No local recurrence by CT scan or MRI of the pelvis
  • No metastases by bone scan and chest x-ray NOTE: Prior Prostascint scans allowed regardless of results
  • At least 3 prostate-specific antigen (PSA) measurements obtained over at least 90 days after radical prostatectomy on post-radiotherapy PSA nadir must be available
  • PSA at least 2 ng/mL after prostatectomy OR at least 4 ng/mL after prior radiotherapy
  • Patients previously treated with radiotherapy must have a PSA clearly rising from lowest value within 6 months after completion of therapy

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • At least 12 months

Hematopoietic

  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL

Hepatic

  • Bilirubin no greater than upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 2 times ULN

Renal

  • Creatinine less than 1.8 mg/dL
  • Phosphorus normal
  • No hypercalcemia (albumin-corrected calcium greater than ULN)
  • No nephrolithiasis
  • Single episode of renal lithiasis allowed provided episode occurred more than 5 years prior to study

Other

  • Fertile patients must use effective double-barrier contraception for at least 1 week before, during, and for at least 2 weeks after study
  • No symptomatic pancreatitis
  • No uncontrolled diabetes
  • No known or suspected inability to comply with study requirements (e.g., abuse of alcohol/drugs or psychotic states)
  • Curatively treated condition associated with renal stones (e.g., hyperparathyroidism, bladder dysfunction, or obstructive uropathy) allowed provided patient has been free of stone formation for more than 5 years

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy for prostate cancer
  • At least 24 months since prior chemotherapy for other diseases

Endocrine therapy

  • More than 6 months since prior hormonal therapy, including neoadjuvant or adjuvant androgen deprivation therapy (e.g., luteinizing hormone-releasing hormone analogue or antiandrogen)
  • No prior androgen deprivation therapy of more than 8 months duration
  • No prior hormonal therapy for prostate cancer more than 3 months after definitive local therapy
  • No concurrent androgen therapy

Radiotherapy

  • See Disease Characteristics
  • More than 3 months since prior radiotherapy for locally recurrent prostate cancer
  • No concurrent radiotherapy, including for pain control

Surgery

  • See Disease Characteristics

Other

  • More than 4 weeks since prior investigational drugs
  • No concurrent medication known to affect systemic calcium metabolism, including any of the following:
  • More than 400 IU of cholecalciferol supplements
  • More than 500 IU of vitamin A supplements
  • Calcium supplements
  • Fluoride
  • Antiepileptics

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Hillman Cancer Center at University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15232

Other trials in United States

About this study

Official title: Calcitriol + Dexamethasone in Early, Recurrent Prostate Cancer Following Local Therapy, A Phase I/II Trial

RATIONALE: Calcitriol may help tumor cells develop into normal cells. Dexamethasone may increase the effectiveness of calcitriol by making tumor cells more sensitive to the drug.

PURPOSE: Phase II trial to study the effectiveness of combining calcitriol with dexamethasone in treating patients with prostate cancer who have undergone surgery or radiation therapy.

Read the detailed description

OBJECTIVES:

  • Determine whether calcitriol and dexamethasone can slow the rise in prostate-specific antigen (PSA) levels in patients with early, recurrent prostate cancer after prior radical prostatectomy or radiotherapy.
  • Determine the safety of this regimen in these patients.
  • Determine the utility of serum PSA in monitoring the therapeutic effect of calcitriol in these patients.

OUTLINE: Patients are stratified according to prior therapy (radical prostatectomy vs radiotherapy).

Patients receive oral calcitriol once daily on days 1-3 alone on week 1. Beginning on week 3, patients receive calcitriol as in week 1 and oral dexamethasone on days 0-4. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 56 patients (28 per stratum) will be accrued for this study.

Conditions
Prostate Cancer
Being tested
calcitriol, dexamethasone
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.

Timeline

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

  1. First posted6 Feb 2003 (estimated)
  2. Study startApr 2002
  3. Primary completionJan 2006
  4. Study completionMar 2006

Resources

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
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00054522
Sponsor's protocol ID
CDR0000270758
Other IDs
RPCI-RP-0203
Status last verified
Mar 2011
First submitted
5 Feb 2003
Last updated
8 Mar 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing calcitriol and dexamethasone in people with Prostate Cancer, run by Roswell Park Cancer Institute at 2 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 8 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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. 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?
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 8 Mar 2011.

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