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

NCT00244920 | Withdrawn Phase 2

• 3 other identifiers: CDR0000446087OHSU-MSI-1256F-204OHSU-IRB-357
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage III prostate cancer

Outcome Measures

Primary Outcomes (3)

• Tumor response in terms of tumor volume as measured by transrectal ultrasound before and after neoadjuvant treatment

• Tumor response in terms of conventional histopathology as measured by prostatectomy specimens and Gleason scores in comparison to pre-treatment biopsies

• 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 Outcomes (3)

• Safety, feasibility, and tolerability as measured by CTCAE v3.0

• Prostate-specific antigen (PSA) serology as measured by PSA value during and after completion of study treatment

• Survival for up to 3 years after completion of study treatment

Interventions

bicalutamide DRUG

leuprolide acetate DRUG

squalamine lactate DRUG

adjuvant therapy PROCEDURE

antiandrogen therapy PROCEDURE

antiangiogenesis therapy PROCEDURE

conventional surgery PROCEDURE

neoadjuvant therapy PROCEDURE

releasing hormone agonist therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * 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 PATIENT CHARACTERISTICS: Performance status * 0-1 Life expectancy * Not specified Hematopoietic * WBC \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 * Hemoglobin \> 11.0 g/dL Hepatic * Bilirubin \< 2 times upper limit of normal (ULN) * SGOT and SGPT \< 2 times ULN * PT and PTT normal Renal * Creatinine \< 1.8 g/dL Cardiovascular * 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 Pulmonary * No pulmonary embolism within the past 12 months * No exercise-limiting respiratory disease Other * 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 PRIOR CONCURRENT THERAPY: Biologic therapy * No prior squalamine lactate Chemotherapy * No prior chemotherapy for prostate cancer * No concurrent anticancer chemotherapy Endocrine therapy * No concurrent systemic corticosteroids Radiotherapy * No prior radiotherapy for prostate cancer * No concurrent radiotherapy Surgery * No prior surgery for prostate cancer * No other concurrent surgery Other * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

bicalutamide; Leuprolide; squalamine lactate; Chemotherapy, Adjuvant; Androgen Antagonists; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Combined Modality Therapy; Therapeutics; Drug Therapy; Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Mitchell Sokoloff, MD, FACS

  OHSU Knight Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2005
• First Posted: October 27, 2005
• Study Start: January 1, 2002
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: May 28, 2012

Record last verified: 2011-05