Hormone Therapy With or Without Squalamine Lactate in Treating Patients Who Are Undergoing a Radical Prostatectomy for Locally Advanced Prostate Cancer
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: 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 |
- Tumor response in terms of tumor volume as measured by transrectal ultrasound before and after neoadjuvant treatment [ Designated as safety issue: No ]
- Tumor response in terms of conventional histopathology as measured by prostatectomy specimens and Gleason scores in comparison to pre-treatment biopsies [ Designated as safety issue: No ]
- 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 [ Designated as safety issue: No ]
- Safety, feasibility, and tolerability as measured by CTCAE v3.0 [ Designated as safety issue: Yes ]
- Prostate-specific antigen (PSA) serology as measured by PSA value during and after completion of study treatment [ Designated as safety issue: No ]
- Survival for up to 3 years after completion of study treatment [ Designated as safety issue: No ]
| Enrollment: | 0 |
| Study Start Date: | January 2002 |
| Study Completion Date: | June 2007 |
| Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | OHSU Knight Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00244920 History of Changes |
| Other Study ID Numbers: | CDR0000446087, OHSU-MSI-1256F-204, OHSU-IRB-357 |
| Study First Received: | October 25, 2005 |
| Last Updated: | May 24, 2012 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration |
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 Neoplasms Genital Diseases, Male Prostatic Diseases Androgen Antagonists Bicalutamide Hormones Leuprolide Squalamine Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Fertility Agents, Female Fertility Agents Reproductive Control Agents Anti-Bacterial Agents Anti-Infective Agents Anticarcinogenic Agents Protective Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013