AzTrials
AzTrials

Metastatic Malignant Neoplasm in Lymph NodePhase 2NCT01409200

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 testing Antiandrogen Therapy, Axitinib and Radical Prostatectomy in people with Metastatic Malignant Neoplasm in Lymph Node and Prostate Ductal Adenocarcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Antiandrogen Therapy, Axitinib and Radical Prostatectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
1 siteUnited States
Study dates
26 Mar 2012to 5 Feb 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 19Show fewer
  • 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

Who cannot join

  • 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)
Show all 18Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Pre-Surgical Androgen Deprivation Therapy With or Without Axitinib in Previously Untreated Prostate Cancer Patients 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. 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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To compare the proportion of patients progression-free one year after treatment with axitinib plus androgen deprivation versus (vs.) androgen deprivation therapy alone and surgery in newly diagnosed prostate cancer patients with lymph node metastases (TxN1M0 or TxNxM1a) or clinical suspicion of lymph node metastases.

SECONDARY OBJECTIVES:

  1. To compare the rate of pathologic complete response (pCR) in the primary tumor.

II. To evaluate time to progression. III. Describe the perioperative and postoperative morbidity of pre-surgical treatment.

IV. Evaluate the effects of a 6-month time course of androgen deprivation with or without axitinib in prostate cancer tissue and blood.

  1. Develop a prospective tissue archive of prostate tumors that have metastasized to lymph nodes.

OUTLINE:

Patients receive antiandrogen therapy per standard care for 8 weeks.

Patients are then randomized to 1 of 2 treatment arms.

ARM I: Patients receive antiandrogen therapy per standard care and axitinib orally (PO) twice daily (BID) for 4 months. Patients then undergo radical prostatectomy and pelvic lymph node dissection.

ARM II: Patients receive antiandrogen therapy per standard care for 4 months and then undergo radical prostatectomy and pelvic lymph node dissection.

After completion of study treatment, patients are followed up at 1 and 3 months, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then yearly thereafter.

Being tested
Antiandrogen Therapy, Axitinib, Radical Prostatectomy, Regional Lymph Node Dissection
Medical subject headings
Lymphatic Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Antiandrogen TherapyDrug

    Also called ADT, Androgen Deprivation Therapy, Anti-androgen Therapy, Anti-androgen Treatment

    Given per standard of care

  • AxitinibDrug

    Also called AG-013736, AG013736, Inlyta

    Given PO

  • Radical ProstatectomyProcedure or surgery

    Also called Prostatovesiculectomy

    Undergo radical prostatectomy

  • Regional Lymph Node DissectionProcedure or surgery

    Undergo pelvic lymph node dissection

Study groups in NCT01409200
Study groupRoleWhat they receive
Arm I (antiandrogen therapy, axitinib, surgery)ExperimentalPatients receive antiandrogen therapy per standard care and axitinib PO BID for 4 months. Patients then undergo radical prostatectomy and pelvic lymph node dissection.
Receives: Drug: Antiandrogen Therapy; Drug: Axitinib; Procedure: Radical Prostatectomy; Procedure: Regional Lymph Node Dissection
Arm II (antiandrogen therapy, surgery)Active comparatorPatients receive antiandrogen therapy per standard care for 4 months and then undergo radical prostatectomy and pelvic lymph node dissection.
Receives: Drug: Antiandrogen Therapy; Procedure: Radical Prostatectomy; Procedure: Regional Lymph Node Dissection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Participants Progression-free 12 months after surgery

    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.

    Measured: 12 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2011 (estimated)
  2. Study start26 Mar 2012
  3. Primary completion5 Feb 2026
  4. Study completion5 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01409200
Sponsor's protocol ID
2011-0231
Other IDs
NCI-2015-01711, NCI-2011-02749, 2011-0231
Status last verified
Feb 2026
First submitted
2 Aug 2011
Last updated
3 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Antiandrogen Therapy, Axitinib and Radical Prostatectomy in people with Metastatic Malignant Neoplasm in Lymph Node and Prostate Ductal Adenocarcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants Progression-free 12 months after surgery (time frame: 12 months after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01409200.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in