Bicalutamide and Raloxifene in Treating Patients With Metastatic or Hormone-Refractory Prostate Cancer

Mayo Clinic

Status and phase

Completed

Early Phase 1

Conditions

Hormone-resistant Prostate Cancer

Stage IV Prostate Cancer

Adenocarcinoma of the Prostate

Prostate Cancer

Treatments

Procedure: quality-of-life assessment

Drug: raloxifene

Drug: bicalutamide

Study type

Interventional

Funder types

Other

Identifiers

NCT01050842

NCI-2009-01700 (Registry Identifier)

07-008912 (Other Identifier)

MC0851 (Other Identifier)

Details and patient eligibility

About

RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, may lessen the amount of androgens made by the body. Selective estrogen receptor modulators, such as raloxifene, may work together with bicalutamide to stop the growth of prostate cancer.

PURPOSE: This clinical trial studies giving bicalutamide and raloxifene together in treating patients with metastatic or hormone-refractory prostate cancer.

Full description

OBJECTIVES:

I. To describe the 6-month progression-free survival rate, progression-free survival, and overall survival of patients receiving bicalutamide and raloxifene.

II. To describe the adverse event profile of combined treatment with bicalutamide and raloxifene (adverse events graded using the NCI CTCAE version 3.0).

III. To describe the quality of life of patients receiving bicalutamide and raloxifene.

OUTLINE: Patients receive oral bicalutamide and oral raloxifene on days 1-28. Treatment repeats for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3-6 months for up to 3 years.

Enrollment

18 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histological confirmation of prostate adenocarcinoma
Objective disease progression or rising PSA despite androgen deprivation therapy
Progression of measurable disease assessed within 28 days prior to registration; progression of non-measurable disease assessed within 28 days prior to registration; patients with rising PSA must demonstrate a rising trend with two successive elevations at a minimum interval of two weeks
Patients must have been surgically or medically castrated; if the method of castration is LHRH agonists (leuprolide or goserelin) or LHRH antagonists, then the patient should be willing to continue the use of LHRH agonists; castration using LHRH agonist should not be interrupted and patients who have stopped treatment should be willing to restart
If the patient has been treated with non-steroidal antiandrogens (bicalutamide, flutamide, nilutamide, or ketoconazole) then they must have stopped at least 14 days prior to registration for ketoconazole and at least 28 days prior to registration for bicalutamide, flutamide, or nilutamide and the patients must have demonstrated progression
Any patient with documented antiandrogen withdrawal syndrome with bicalutamide would not be eligible
A minimum PSA of 5 ng/ml or new areas of bony metastases on bone scan are required for patients with no measurable disease; no minimum PSA requirement for patients with measureable disease
ECOG Performance Status (PS) 0, 1, or 2
ANC >= 1500
PLT >= 100,000
HgB >= 9.0 g/dL
Total bilirubin =< 1.5 x UNL
SGOT (AST) =< 3 x UNL
SGPT (ALT) =< 3 x UNL
Alkaline Phosphatase =< 3 x UNL
Creatinine =< 1.5 x UNL
Ability to complete questionnaire(s) independently or with assistance
Provide informed written consent
Willingness to return to Mayo Clinic enrolling institution for follow-up

Exclusion criteria

Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Immunocompromised patients (other than that related to the use of corticosteroids) including patients with known HIV infection
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Prior radiation therapy is allowed; at least 21 days must have elapsed since completion of radiation therapy, and patients must have recovered from side effects
Patients may have received prior surgery; at least 21 days must have elapsed since completion of surgery and patient must have recovered from all side effects
The use of bisphosphonates is allowed provided that the patient has been receiving that medication for >= 4 weeks with evidence of progressive disease
Prior systemic therapy to treat prostate cancer including cytotoxic chemotherapy, biologic therapy, vaccine therapy, and experimental therapy is allowed, and at least 28 days must have elapsed since completion of therapy and the patient must have recovered from all side effects
No concurrent use of estrogen, estrogen-like agents, or other hormonal therapy is allowed; prior use of these agents will need to be discontinued >= 4 weeks prior to registration
Active other malignancy, except non-melanotic skin cancer or carcinoma-in-situ of the cervix; if there is a history of prior malignancy, must not be receiving other specific treatment (other than hormonal therapy) for cancer
History of congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
Experienced documented anti-androgen withdrawal syndrome on bicalutamide
History of venous thromboembolic disease or significant risk for venous thromboembolic disease
History of symptomatic coronary artery disease
History of stroke or significant risk for stroke