Sulforaphane in Treating Patients With Recurrent Prostate Cancer

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

This phase II trial studies how well sulforaphane works in treating patients with recurrent prostate cancer. Sulforaphane may prevent or slow the growth of certain cancers.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OHSU Knight Cancer Institute
• Collaborator: The Wayne D. Kuni and Joan E. Kuni Foundation
• Treatments: Sulforafan; Sulforaphane

Criteria

Inclusion Criteria:

• Histopathologically or cytologically proven adenocarcinoma of the prostate treated with either a prostatectomy or definitive radiation (external beam or brachytherapy

• Protocol-Specific Prostate Working Group 2 (PCWG2) Criteria: rising PSA after definitive therapy

• For post surgical patients: the nadir reference value (#1) is the last PSA measured before increases are documented, with subsequent values obtained a minimum of 1 week apart; if the PSA at time point 3 (value #3A) is greater than that at point 2, then eligibility has been met; if the PSA is not greater than point 2 (value #3B), but value #4 is, the patient is eligible assuming that other criteria are met and values 3A or #4 are 1.0 ng/mL or higher

• For post radiation therapy patients: the nadir reference value (#1) is the last PSA measured before increases are documented, with subsequent values obtained a minimum of 1 week apart; if the PSA at time point 3 (value #3A) is greater than that at point 2, then eligibility has been met; if the PSA is not greater than point 2 (value #3B), but value #4 is, the patient is eligible assuming that other criteria are met and if values 3A or #4 are 2.0 ng/mL or more above the nadir reference value (#1) according to Phoenix/American Society for Therapeutic Radiology and Oncology (ASTRO) criteria

• Eastern Cooperative Oncology Group (ECOG) performance status <= 2

• The following laboratory results within 4 weeks prior to starting study treatment:

• White blood cells (WBC) >= 3000/mm^3

• Neutrophil >= 1,500/mm^3

• Platelet >= 100,000/mm^3

• Serum creatinine =< upper limit of normal (ULN)

• Albumin > 3.0 gm/dL

• Total bilirubin < 1.5 X ULN

• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 1.5 X ULN

• Testosterone level >= 150ng/dL, and no evidence of progression while on prior hormonal therapy, if applicable (i.e. patient must be non-castrate resistant).

• Prior androgen therapy is allowed as long as the patient did not progress while on therapy.

• The following imaging scans within 12 weeks prior to starting study treatment: Whole Body Bone Scan: computed tomography (CT) Chest/Abdomen/Pelvis w/ contrast; NOTE: if contrast medium for CT scan is contraindicated for the patient, documentation of this is required and a CT scan with contrast will not be required; subject still must obtain a CT without contrast, though.

• Willingness to use effective contraception by study participants or their female partners throughout the treatment period and for at least 2 months following treatment

• Signed informed patient consent and Health Insurance Portability and Accountability Act (HIPAA) within 3 months prior to starting treatment

Exclusion Criteria:

• Significant active medical illness which in the opinion of the investigator would preclude protocol treatment

• Measurable and/or evaluable recurrent prostate cancer by imaging (CT scan of the chest, abdomen, and pelvis and bone scan performed within 12 weeks prior to starting treatment) or by physical exam

• Prior investigational therapy within 30 days prior to starting study treatment

• Prior treatment with a known histone deacetylase inhibitor (including but not limited to valproic acid, suberoylanilide hydroxamic acid [SAHA],Panobinostat (LBH589), etc) within 6 months prior to starting study treatment or while on study therapy

• Concurrent systemic treatment for prostate cancer

• Current treatment with warfarin

• Gastrointestinal ailments which would interfere with the ability to adequately absorb sulforaphane

• Allergy to cruciferous vegetables

• Any condition which, in the opinion of the study clinician, would make participation in the study harmful to the patient