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NCT01409200 · ClinicalTrials.gov registry record · Phase 2
Antiandrogen Therapy With or Without Axitinib Before Surgery in Treating Patients With Previously Untreated Prostate Cancer With Known or Suspected Lymph Node Metastasis
A Phase 2 study of Stage IV Prostate Adenocarcinoma AJCC v7 and Stage III Prostate Adenocarcinoma AJCC v7, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 73
- Enrollment target
- 1
- Study location
NCT01409200: Completed Phase 2 study of Stage IV Prostate Adenocarcinoma AJCC v7 and Stage III Prostate Adenocarcinoma AJCC v7, sponsored by M.D. Anderson Cancer Center.
NCT01409200 is a Phase 2 study of Stage IV Prostate Adenocarcinoma AJCC v7 and Stage III Prostate Adenocarcinoma AJCC v7 that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 73 participants, below the 155-participant average among 7 other Stage IV Prostate Adenocarcinoma AJCC v7 trials with a reported enrollment target (53% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01409200, a Phase 2 study of Stage IV Prostate Adenocarcinoma AJCC v7 and Stage III Prostate Adenocarcinoma AJCC v7, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 73 participants
- Enrollment target
- 1
- Study location
Study Summary
This randomized phase IIA trial studies how well antiandrogen therapy works with or without axitinib before surgery in treating patients with previously untreated prostate cancer that is known or suspected to have spread to lymph nodes. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as antiandrogen therapy may lessen the amount of androgen made by the body. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if antiandrogen therapy is more effective with or without axitinib before surgery in treating patients with prostate cancer.
Primary Outcome
Time to Prostate-specific antigen (PSA)-progression measured from the date of radical prostatectomy to the occurrence of a serum PSA \>1.0 ng/mL (confirmed by a second measurement at least 2 weeks apart). PSA-monitoring every 3 months after surgery for the first 12 months, every 4 months in the second year, every 6 months in the third to fifth year, and yearly thereafter until PSA or radiologic progression.
Conditions Studied
Interventions
- PROCEDURE Radical Prostatectomy
- DRUG Antiandrogen Therapy
- DRUG Axitinib
- PROCEDURE Regional Lymph Node Dissection
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2012-03-26 |
| Est. Completion | 2026-02-05 |
| Phase | Phase 2 |
What the finished NCT01409200 record still lists
NCT01409200 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 155-participant average among 7 other Stage IV Prostate Adenocarcinoma AJCC v7 trials with a reported enrollment target (53% lower).
The record links to 4 conditions, with Stage IV Prostate Adenocarcinoma AJCC v7 appearing as the primary indexed condition, and to 4 interventions - of which Radical Prostatectomy is the first listed.
NCT01409200 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01409200 about?
NCT01409200 is a clinical study titled "Antiandrogen Therapy With or Without Axitinib Before Surgery in Treating Patients With Previously Untreated Prostate Cancer With Known or Suspected Lymph Node Metastasis". This randomized phase IIA trial studies how well antiandrogen therapy works with or without axitinib before surgery in treating patients with previously untreated prostate cancer that is known or suspected to have spread to lymph nodes. Androgens can cause the growth of prostate cancer cells. Antiho...
What is the current status of trial NCT01409200?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 73 participants. The study started on 2012-03-26. Estimated completion is 2026-02-05.
What conditions does trial NCT01409200 study?
This clinical trial studies the following conditions: Stage IV Prostate Adenocarcinoma AJCC v7, Stage III Prostate Adenocarcinoma AJCC v7, Prostate Ductal Adenocarcinoma, Metastatic Malignant Neoplasm in Lymph Node.
What interventions are being tested in trial NCT01409200?
The interventions under investigation include: Radical Prostatectomy (PROCEDURE), Antiandrogen Therapy (DRUG), Axitinib (DRUG), Regional Lymph Node Dissection (PROCEDURE).
Who is sponsoring clinical trial NCT01409200?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01409200 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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