| September 29, 2006 |
| October 6, 2009 |
| March 2005 |
| July 2007 (final data collection date for primary outcome measure) |
| PSA response - 50% PSA decline, PSA progression, PSA response duration, progressive disease, time to PSA progression. [ Designated as safety issue: No ] |
| PSA response - 50% PSA decline, PSA progression, PSA response duration, progressive disease, time to PSA progression. |
| Complete list of historical versions of study NCT00383487 on ClinicalTrials.gov Archive Site |
| Progressive disease in this study's patients, who would be treated with calcitriol and naprosyn, will be compared to that in historical controls of patients treated with calcitriol alone. [ Designated as safety issue: No ] |
| Progressive disease in this study’s patients, who would be treated with calcitriol and naprosyn, will be compared to that in historical controls of patients treated with calcitriol alone. |
| |
| A Phase II Trial of Calcitriol and Naproxen in Patients With Recurrent Prostate Cancer |
| A Phase II Trial of Calcitriol and Naproxen in Patients With Recurrent Prostate Cancer |
To determine whether, in this patient population, treatment with calcitriol and Naproxen is more effective in delaying the growth of prostate cancer than treatment with calcitriol alone as seen in historical controls. |
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. |
| Phase II |
| Interventional |
| Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Prostatic Neoplasms |
- Drug: DN-101
- Drug: Naproxen (Naprosyn)
|
| |
| |
| |
| Suspended |
| 30 |
|
| July 2007 (final data collection date for primary outcome measure) |
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
|
| Male |
| 18 Years to 90 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00383487 |
| Dr. Sandy Srinivas, Stanford University School of Medicine |
| PROS0021, 95804, NCT00383487, PROS0021 |
| Stanford University |
| Novacea |
| Principal Investigator: |
Dr. Sandy Srinivas |
Stanford University |
|
|
| Stanford University |
| October 2009 |
