Hormone Therapy With or Without Squalamine Lactate in Treating Patients Who Are Undergoing a Radical Prostatectomy for Locally Advanced Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00244920
Recruitment Status : Withdrawn (Sponsor withdrew drug.)
First Posted : October 27, 2005
Last Update Posted : May 28, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
OHSU Knight Cancer Institute

Brief Summary:

RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as leuprolide and bicalutamide, may stop the adrenal glands from making androgens. Squalamine lactate may stop the growth of prostate cancer by blocking blood flow to the tumor. Giving hormone therapy together with squalamine lactate before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This randomized phase II trial is studying how well giving hormone therapy together with squalamine lactate works compared to hormone therapy alone in treating patients who are undergoing a radical prostatectomy for locally advanced prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: bicalutamide Drug: leuprolide acetate Drug: squalamine lactate Procedure: adjuvant therapy Procedure: antiandrogen therapy Procedure: antiangiogenesis therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Procedure: releasing hormone agonist therapy Phase 2

Detailed Description:


  • Compare the effect of neoadjuvant androgen-ablation therapy with vs without squalamine lactate on induced tumor regression and grade migration in patients with locally advanced high-risk adenocarcinoma of the prostate undergoing a radical prostatectomy.
  • Compare the duration of clinical disease-free survival of patients treated with these regimens.
  • Determine the applicability of prostate-specific antigen (PSA) serology as an endpoint determinant in patients treated with these regimens.
  • Compare the feasibility and potential safety effects on wound healing and recovery in patients treated with these regimens before and after a radical prostatectomy.

OUTLINE: This is an open-label, randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive leuprolide intramuscularly once a month for 3 months and oral bicalutamide once a day for 2 weeks.
  • Arm II: Patients receive leuprolide and bicalutamide as in arm I plus squalamine lactate IV over 4 hours once weekly for 6 weeks.

Seven weeks after beginning treatment, patients in both arms undergo standard radical prostatectomy. Patients then continue to receive leuprolide and bicalutamide with or without squalamine lactate for up to 6 additional weeks.

After completion of study treatment, patients are followed periodically for at least 3 years.

PROJECTED ACCRUAL: A total of 132 patients (66 per treatment arm) will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Randomized Phase 2 Study To Evaluate The Activity, Tolerability, And Toxicity Of Combined Neoadjuvant Anti-angiogenesis and Androgen Ablation Therapy in Men Undergoing Radical Prostatectomy
Study Start Date : January 2002
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Tumor response in terms of tumor volume as measured by transrectal ultrasound before and after neoadjuvant treatment
  2. Tumor response in terms of conventional histopathology as measured by prostatectomy specimens and Gleason scores in comparison to pre-treatment biopsies
  3. Tumor response in terms of molecular markers as measured by changes in VEGF, VEGF-flt-1, and integrin Alpha6Beta4, AlphaVBeta3, and AlphaVBeta5 expression in pre-treatment biopsy and post-treatment prostatectomy specimens

Secondary Outcome Measures :
  1. Safety, feasibility, and tolerability as measured by CTCAE v3.0
  2. Prostate-specific antigen (PSA) serology as measured by PSA value during and after completion of study treatment
  3. Survival for up to 3 years after completion of study treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of the prostate

    • Locally advanced disease

      • No metastatic disease
  • High-risk characteristics, meeting ≥ 1 of the following criteria:

    • Large, hard tumor on digital exam
    • Aggressive-appearing cancer cells on biopsy
  • Prostate-specific antigen > 10 ng/mL


Performance status

  • 0-1

Life expectancy

  • Not specified


  • WBC > 1,500/mm^3
  • Platelet count > 100,000/mm^3
  • Hemoglobin > 11.0 g/dL


  • Bilirubin < 2 times upper limit of normal (ULN)
  • SGOT and SGPT < 2 times ULN
  • PT and PTT normal


  • Creatinine < 1.8 g/dL


  • No history of ventricular arrhythmia or dysfunction
  • No congestive heart failure
  • No symptomatic coronary artery disease
  • No prior myocardial infarction
  • No history of thromboembolic disease (e.g., deep vein thrombosis or stroke) within the past 12 months
  • No other significant cardiovascular disease


  • No pulmonary embolism within the past 12 months
  • No exercise-limiting respiratory disease


  • Fertile patients must use effective barrier method contraception
  • No sexual intercourse for 6 weeks after surgery
  • No uncontrolled diabetes
  • No serious acute infection
  • No other malignancy except nonmelanoma skin cancer


Biologic therapy

  • No prior squalamine lactate


  • No prior chemotherapy for prostate cancer
  • No concurrent anticancer chemotherapy

Endocrine therapy

  • No concurrent systemic corticosteroids


  • No prior radiotherapy for prostate cancer
  • No concurrent radiotherapy


  • No prior surgery for prostate cancer
  • No other concurrent surgery


  • At least 6 weeks since prior and no concurrent use of over-the-counter or herbal drugs that have estrogenic activity
  • No participation in another investigational study within the past 3 months
  • No concurrent participation in another investigational study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00244920

Sponsors and Collaborators
OHSU Knight Cancer Institute
National Cancer Institute (NCI)
Study Chair: Mitchell Sokoloff, MD, FACS OHSU Knight Cancer Institute

Responsible Party: OHSU Knight Cancer Institute Identifier: NCT00244920     History of Changes
Other Study ID Numbers: CDR0000446087
First Posted: October 27, 2005    Key Record Dates
Last Update Posted: May 28, 2012
Last Verified: May 2011

Keywords provided by OHSU Knight Cancer Institute:
adenocarcinoma of the prostate
stage III prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Androgen Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Anti-Bacterial Agents
Anti-Infective Agents
Anticarcinogenic Agents
Protective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors