Clinical trial · Interventional
Calcitriol, Mitoxantrone, and Prednisone in Treating Patients With Metastatic Prostate Cancer
Phase II Study of DN-101 (High Dose Pulse Calcitriol), Mitoxantrone, Prednisone in Androgen-Independent Prostate Cancer (AIPC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Calcitriol may cause prostate cancer cells to look more like normal cells, and to grow and spread more slowly. Drugs used in chemotherapy, such as mitoxantrone and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well giving calcitriol together with mitoxantrone and prednisone works in treating patients with metastatic prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| calcitriol | Dietary Supplement | — | UNRESOLVED |
| mitoxantrone hydrochloride | Drug | Mitoxantrone | ALIAS |
| prednisone | Drug | Prednisone | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Reduction in serum prostate-specific antigen (PSA) by 50% measured every 21 days
Secondary outcomes (13)
- measure
- Toxicity as measured by Common Toxicity Criteria v3.0
- measure
- Frozen plasma and serum samples for correlative biomarker analysis collected every 21 days
- measure
- Confirmed PSA reduction > 75% measured every 21 days
- measure
- PSA normalization (< 4 ng/mL) measured every 21 days
- measure
- Response to measurable disease as measured by RECIST criteria every 9 weeks
- measure
- Analgesic response as measured by McGill-Melzack Pain Questionnaire every 21 days
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed prostate cancer
* Androgen-independent disease, defined as disease progression while on standard hormonal management, including antiandrogen withdrawal
* Patients must continue primary hormonal therapy during study treatment
* Regional or distant metastases
* Prostate-specific antigen \> 5 ng/mL
* No brain metastases
PATIENT CHARACTERISTICS:
Age
* 18 to 100
Performance status
* ECOG 0-3
Life expectancy
* Not specified
Hematopoietic
* Adequate hematologic function
Hepatic
* Adequate hepatic function
Renal
* Adequate renal function
* No calcium-salt kidney stones within the past 5 years
* No hypercalcemia
Cardiovascular
* Adequate cardiac function
* No significant cardiac disease
* No atrial fibrillation
Other
* Fertile patients must use effective barrier contraception during and for 2 months after completion of study treatment
* No other serious medical illness
* No other active malignancy except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
* More than 28 days since prior biologic therapy
Chemotherapy
* No prior chemotherapy
Endocrine therapy
* See Disease Characteristics
Radiotherapy
* No prior strontium chloride Sr 89
* More than 28 days since prior radiotherapy
* More than 56 days since prior samarium Sm 153 lexidronam pentasodium
Surgery
* Prior prostatectomy and/or orchiectomy allowed
Other
* More than 28 days since prior investigational therapyReferences
Publications (1)
- RESULTChan JS, Beer TM, Quinn DI, Pinski JK, Garzotto M, Sokoloff M, Dehaze DR, Ryan CW. A phase II study of high-dose calcitriol combined with mitoxantrone and prednisone for androgen-independent prostate cancer. BJU Int. 2008 Dec;102(11):1601-6. doi: 10.1111/j.1464-410X.2008.08017.x. Epub 2008 Sep 8. PMID 18782306