Sulforaphane in Treating Patients With Recurrent Prostate Cancer
Condition: Adenocarcinoma of the Prostate; Recurrent Prostate Cancer
MeSH terms: Prostatic Neoplasms; Recurrence
Intervention: Sulforaphane; Laboratory biomarker analysis; Pharmacological study
Intervention description: Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.; Correlative studies; Correlative studies
Intervention MeSH terms: Sulforaphane
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: sulforaphane; broccoli sprout extract (BSE); prostate cancer; recurrent prostate cancer; phase II

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.
    

Eligibility 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