Hormone-Refractory Prostate Cancer Clinical Trial
Official title:
A Phase II Study of Docetaxel Plus Carboplatin in Chemonaive Hormone-Refractory Prostate Cancer (HRPC) Patients
The primary objective is to determine the efficacy of docetaxel plus carboplatin as first line treatment in patients with hormone refractory prostate cancer.
Docetaxel-prednisolone is the current standard in HRPC, based on 2 large randomized trials showing improved survival compared to mitoxantrone-prednisolone. Carboplatin has activity in prostate cancer and the combination of Docetaxel-carboplatin is known to be synergistic and is used with good effect in many cancers. The advantage of using this combination in prostate cancer is suported by clinical data: high response rates of docetaxel-carboplatin-estramustine (with G-CSF support) in a phase II trial (Oh, Halabi, Kelly et al. Cancer. 2003 Dec 15;98(12):2592-8), and additional effect of this combination in prior taxane failures (Oh, George, Tay. Clin Prostate Cancer. 2005 Jun;4(1):61-4). Carboplatin itself has activity and theoretically could target the more hormone resistant clones or neuroendocrine components of the tumor.(Di Sant' Agnese. J Urol. 1994 Nov;152(5 Pt 2):1927-31.) We are studying the combination of docetaxel-carboplatin both given in a weekly, low-dose fashion, without estramustine and without G-CSF. This is expected to be an effective and tolerable treatment for HRPC patients. We will be documenting (to our knowledge) for the first time in this trial the efficacy of the combination given in this particular dose and schedule. ;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03076203 -
Phase IB Trial of Radium-223 and Niraparib in Patients With Castrate Resistant Prostate Cancer (NiraRad)
|
Phase 1 | |
| Terminated |
NCT01450683 -
Study of Itraconazole in Castrate-resistant Prostate Cancer (CRPC) Post-chemotherapy
|
Phase 2 | |
| Terminated |
NCT01020305 -
Temsirolimus to Reverse Androgen Insensitivity for Castration-resistant Prostate Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT00201357 -
An Open Trial to Assess the Efficacy and Safety of Oral Thalidomide in Patients With Hormone-Refractory Prostate Cancer
|
Phase 2 | |
| Completed |
NCT00337077 -
Eribulin Mesylate in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
|
Phase 2 | |
| Completed |
NCT01133704 -
Immunotherapy With APC8015 (Sipuleucel-T, Provenge) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer
|
Phase 3 | |
| Recruiting |
NCT03016741 -
Cognitive Effects of Androgen Receptor Directed Therapies for Advanced Prostate Cancer
|
Phase 4 | |
| Completed |
NCT00570700 -
Trial of Dasatinib (Sprycel®) in Subjects With Hormone-refractory Prostate Cancer
|
Phase 2 | |
| Completed |
NCT02288936 -
Analyze the Predictive Value of Gene TMPRSS2-ETS in Response to Enzalutamide in Patients With Prostate Cancer
|
Phase 2 | |
| Completed |
NCT00636740 -
Multi-Center Phase II Study to Compare MER-101 20mg Tablets to Intravenous Zometa 4mg in Male Bisphosphonate-Naive, Hormone Refractory Prostate Cancer Patients
|
Phase 2 | |
| Completed |
NCT01631552 -
Study of Sacituzumab Govitecan-hziy (IMMU-132) in Adults With Epithelial Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT01422850 -
Safety Study of Repeated Dosing of a Cytotoxic Lymphocytes (CTL) Based Prostate Cancer Therapy
|
Phase 1 | |
| Recruiting |
NCT05997615 -
Safety, Pharmacokinetics, and Preliminary Efficacy of AMX-500 in Metastatic Castration Resistant Prostate Cancer (mCRPC)
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03658434 -
Palliative Radiotherapy to Dominant Symptomatic Lesion in Patients With Hormone Refractory Prostate Cancer
|
N/A | |
| Completed |
NCT00891345 -
Safety Study of a Cytotoxic Lymphocytes (CTL) Based Prostate Cancer Therapy
|
Phase 1 | |
| Completed |
NCT00151073 -
Estramustine, Docetaxel and Zoledronate Treatment in Hormone-Refractory Adenocarcinoma of the Prostate
|
Phase 2 | |
| Terminated |
NCT00048659 -
YM598 Added to Mitoxantrone/Prednisone to Control Pain in Metastatic Prostate Cancer Patients No Longer Responding to Hormone Therapy
|
Phase 2 | |
| Completed |
NCT00082134 -
Study of ILX651 in Patients With Hormone-Refractory Prostate Cancer Previously Treated With Docetaxel
|
Phase 2 |