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A Phase II Trial of Calcitriol and Naproxen in Patients With Recurrent Prostate Cancer


Phase 2
18 Years
90 Years
Not Enrolling
Male
Prostatic Neoplasms, Prostate Cancer

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Trial Information

A Phase II Trial of Calcitriol and Naproxen in Patients With Recurrent Prostate Cancer


In summary, in vitro and in vivo studies, as well as early phase clinical trial, have shown
a promising role for both calcitriol and NSAIDs in the treatment of prostate cancer.
Moreover, calcitriol and NSAIDs both exert their antiproliferative effect by decreasing
prostaglandin levels, but they do so by different mechanisms. Thus, there is reason to
believe that their combined effects on prostaglandins may be synergistic. Preliminary in
vitro assays in which calcitriol is given in combination with one of two different NSAIDs
(Naprosyn or sulindac) to LNCaP cell lines have indicated such synergy. This observation
provides the rational for using them in combination for the treatment of prostate cancer. In
addition, it is hoped that any synergy noted would allow for the use of lower doses of
NSAIDs.


Inclusion Criteria:



- Must give written informed consent

- Histologically confirmed adenocarcinoma of the prostate

- Biochemical relapse after primary radiation therapy or surgery

- Normal testosterone levels

- 3 rising PSA after nadir, with interval between PSA determinations > 2 weeks

Exclusion Criteria:

- Local recurrence by CT scan

- Distant metastases by bone scan

- Hypercalcemia

- Nephrolithiasis

- Renal insufficiency (serum creatinine > 1.8 mg/dl)

- Pancreatitis

- History of ulcer or gastrointestinal bleeding

- More than 6 months of hormone ablation therapy

- Concurrent therapy for prostate cancer

- Uncontrolled HTN

- H/O MI, CVA, TIA

- Known coronary disease/cerebrovascular disease

- Platelet counts <50

- Patients on anticoagulants

- Patients on lithium

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PSA response - 50% PSA decline, PSA progression, PSA response duration, progressive disease, time to PSA progression.

Outcome Time Frame:

unknown

Safety Issue:

No

Principal Investigator

Dr. Sandy Srinivas

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

PROS0021

NCT ID:

NCT00383487

Start Date:

March 2005

Completion Date:

July 2007

Related Keywords:

  • Prostatic Neoplasms
  • Prostate Cancer
  • Neoplasms
  • Prostatic Neoplasms

Name

Location
Stanford University School of Medicine Stanford, California  94305-5317