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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


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Mitchell Sokoloff, MD, FACS

Investigator Role:

Study Chair

Investigator Affiliation:

OHSU Knight Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000446087

NCT ID:

NCT00244920

Start Date:

January 2002

Completion Date:

June 2007

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage III prostate cancer
  • Prostatic Neoplasms

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