New drug combo tested to stop prostate cancer spread before surgery
NCT ID NCT01409200
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether adding the drug axitinib to standard hormone therapy before surgery helps men with prostate cancer that has spread to lymph nodes. About 73 men received either hormone therapy alone or hormone therapy plus axitinib before having their prostate removed. The goal was to see if the combination delays cancer recurrence after surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- hormone therapy (androgen deprivation therapy) and axitinib
- What this could lead to
- If successful, this could point toward a more effective pre-surgery treatment for prostate cancer that has spread to lymph nodes.
- What could go wrong
- This is a small, early-phase trial (73 people) with no results yet. Adding axitinib may not improve outcomes and could increase side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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73 people
The number who actually took part.
- Started
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Mar 2012
- Finished
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Feb 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients with adenocarcinoma of the prostate that in the opinion of the urologist could be resected after response to systemic therapy; ductal adenocarcinoma is permitted * Patients must be regarded as acceptable surgical risk for radical prostatectomy and confirm their intention to undergo radical prostatectomy at the end of the pre-surgical therapy * Eastern Cooperative Oncology Group (ECOG) performance status 2 or better * All patients must have thorough tumor staging and meet at least one of the following criteria: * Either lymph node biopsy or lymph node dissection demonstrating lymph node metastasis by prostate cancer * Non-bulky (\< 5 cm) regional pelvic or distant lymphadenopathy visualized on computed tomography (CT)/magnetic resonance imaging (MRI) scan; lymph node biopsy is required if \< 2.0 cm or in atypical distribution * Primary tumor Gleason score \>= 8 and serum prostate-specific antigen (PSA) concentration \>= 25 ng/mL, indicating high risk of occult lymph node metastases * Primary clinical tumor stage of T3 and Gleason score \>= 7, indicating high risk of occult lymph node metastases * Primary tumor stage T4, indicating high risk of occult lymph node metastases; patients in any of these groups and less than 3 sites of non-predominantly lytic bone metastasis will be still considered eligible for the trial; the 2010 American Joint Committee on Cancer (AJCC) staging system will be followed * Prior hormonal therapy (luteinizing hormone-releasing hormone \[LHRH\] agonist/antagonist with or without antiandrogen) up to 8 weeks is permitted * Absolute peripheral neutrophil count (ANC) of \>= 1,500/mm\^3 * Platelet count of \>= 100,000/mm\^3 * Total bilirubin of =\< 1.5 x upper limit of normal (ULN) * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x ULN * Serum creatinine =\< 1.5 x ULN or clearance \>= 60 mL/min (measured or calculated) * Urinary protein \< 2+ by urine dipstick (if \>= 2+, a 24-hour urine protein must show protein \< 2 g per 24 hours) * Patients or their partners must be surgically sterile or must agree to use effective contraception while receiving study treatment and for at least 3 months thereafter; the definition of effective contraception should be in agreement with local regulation and based on the judgment of the principal investigator or a designated associate * Patients must sign the current institutional review board (IRB) approved informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the institution, and willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures * All patients must have a surgical and medical oncology consult prior to signing informed consent Exclusion Criteria: * Patients with biopsy-proven small cell or sarcomatoid histology * Patients with clinical or radiological evidence of bone (\>= 3 sites, or predominantly lytic if \< 3) or other extranodal metastasis * Patients who have had prior chemotherapy, experimental agents for prostate cancer, or patients receiving more than 8 weeks of prior hormone therapy will be excluded * Gastrointestinal abnormalities such as inability to take oral medication; requirement for intravenous alimentation; prior surgical procedures affecting absorption including total gastric resection; treatment for active peptic ulcer disease in the past 6 months; active gastrointestinal bleeding as evidenced by hematemesis, hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy; malabsorption syndromes * Anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors (i.e., verapamil, ketoconazole, miconazole, itraconazole, erythromycin, telithromycin, clarithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir and delavirdine); grapefruit juice is also a CYP3A4 inhibitor * Anticipated need for treatment with drugs that are known CYP3A4 or CYP1A2 inducers (i.e. carbamazepine, dexamethasone, felbamate, omeprazole, phenobarbital, phenytoin, amobarbital, nevirapine, primidone, rifabutin, rifampin, and St. John's wort) * Patients with any infectious process that, in the opinion of the investigator, could worsen or its outcome be affected as a result of the investigational therapy * Patients with symptomatic congestive heart failure, unstable angina or myocardial infarction, coronary/peripheral artery bypass graft or repair, cerebrovascular accident or transient ischemic attack in the 12 months prior to randomization; or deep vein thrombosis or pulmonary embolism in the 6 months prior to randomization * Persistently uncontrolled diabetes mellitus, oxygen-dependent lung disease, chronic liver disease, or human immunodeficiency virus (HIV) infection * Inadequately controlled hypertension (defined as systolic blood pressure \> 140 mmHg and/or diastolic blood pressure \> 90 mmHg) despite antihypertensive medication, or prior history of hypertensive crisis or hypertensive encephalopathy * Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation) * Anticipation of need for major surgical procedure during the course of the study other than as outlined by the protocol * History of abdominal fistula or gastrointestinal perforation within 6 months prior to randomization * Serious, non-healing wound, active ulcer, or untreated bone fracture; any bone fractures must be healed * Known hypersensitivity to any component of axitinib or prior use of axitinib * Second malignancies (excluding non-melanoma skin cancer) unless treated with curative intent and disease-free for 3 years * Overt psychosis, mental disability, otherwise incompetent to give informed consent, or history of non-compliance * Planned participation in any other experimental drug study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
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Other studies related to the condition(s) this trial covers.
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