Adenocarcinoma of the Prostate Clinical Trial
Official title:
Phase II Study of Antineoplastons A10 and AS2-1 Capsules With Total Androgen Blockade in Patients With Stage III or IV Adenocarcinoma of the Prostate
RATIONALE: Antineoplastons are naturally occurring substances that may also be made in the
laboratory. Antineoplastons may inhibit the growth of cancer cells.
PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating
patients with stage III or stage IV prostate cancer.
OBJECTIVES:
- Determine the antitumor activity of antineoplastons A10 and AS2-1 capsules in
combination with total androgen blockade in patients with localized, regional or
metastatic adenocarcinoma of the prostate by determining the proportion of patients who
experience an objective tumor response.
- Evaluate the adverse effects of and tolerance to this regimen in these patients.
OUTLINE: This is an open-label study.
Patients receive gradually escalating doses of antineoplastons A10 and AS2-1 capsules orally
6-7 times daily until the maximum tolerated dose is reached. Treatment continues for at
least 3 months in the absence of disease progression or unacceptable toxicity. Concurrently,
patients continue hormonal therapy with flutamide, leuprolide, or bicalutamide at the same
dose as before beginning antineoplaston therapy.
Tumors are measured every 4 months for 2 years, every 6 months for 2 years, and then
annually for 2 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
;
Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02217709 -
Phenelzine Sulfate in Treating Patients With Non-metastatic Recurrent Prostate Cancer
|
Phase 2 | |
| Completed |
NCT03077659 -
Trial of NanoPac® Focal Therapy in Subjects With Prostate Cancer
|
Phase 2 | |
| Recruiting |
NCT03624660 -
Dose-Escalated Proton Radiation Therapy for High-Risk Prostate Cancer
|
N/A | |
| Completed |
NCT01054079 -
Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer
|
Phase 2 | |
| Terminated |
NCT00512668 -
Hormone Therapy and Temsirolimus in Treating Patients With Relapsed Prostate Cancer
|
Phase 1 | |
| Completed |
NCT00087139 -
Ixabepilone in Treating Patients With Metastatic Prostate Cancer
|
Phase 2 | |
| Completed |
NCT00182052 -
Rosiglitazone (Avandia) vs. Placebo for Androgen Dependent Prostate Cancer
|
Phase 3 | |
| Active, not recruiting |
NCT03511196 -
Intermittent Androgen Deprivation Therapy for Stage IV Castration Sensitive Prostate Cancer
|
Early Phase 1 | |
| Active, not recruiting |
NCT01655836 -
High-Dose Rate Brachytherapy and Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer
|
N/A | |
| Terminated |
NCT03535675 -
Muscadine Plus (MPX) In Men With Prostate Cancer
|
Phase 3 | |
| Terminated |
NCT01866423 -
Orteronel in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
|
Phase 2 | |
| Completed |
NCT02234921 -
Pilot Study of DRibble Vaccine for Prostate Cancer Patients
|
Phase 1 | |
| Completed |
NCT01468532 -
Docetaxel, Prednisone, and Pasireotide in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03686683 -
Open- Label Trial of Sipuleucel-T Administered to Active Surveillance Patients for Newly Diagnosed Prostate Cancer
|
Phase 3 | |
| Active, not recruiting |
NCT03689699 -
Nivolumab and BMS-986253 for Hormone-Sensitive Prostate Cancer (MAGIC-8)
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04694924 -
Prospective Prostate Cancer and Patient-reported Outcomes Registry
|
||
| Active, not recruiting |
NCT04909294 -
Evaluation of the Efficacy and the Safety of a Stereotaxic Prostatic Radiotherapy Delivered With Linac MRI, in Patients With Prostate Adenocarcinoma
|
N/A | |
| Completed |
NCT02225925 -
Intraoperative Dosimetry for Prostate Brachytherapy Using Fluoroscopy and Ultrasound
|
N/A | |
| Completed |
NCT01949519 -
Docetaxel and Lycopene in Metastatic Prostate Cancer
|
Phase 1 | |
| Completed |
NCT01433913 -
Metformin Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery
|
Phase 2 |