Sulforaphane in Treating Patients With Recurrent Prostate Cancer

Completed · Phase 2

Conditions studied: Adenocarcinoma of the Prostate, Recurrent Prostate Cancer

In brief

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.

Key facts

Study ID

NCT01228084

Run by

OHSU Knight Cancer Institute

People needed

20

Starts

2010-11-01

Expected to finish

2013-05-01

Last updated by the study team

2017-04-28

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• OHSU Knight Cancer Institute — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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