Adenocarcinoma of the Prostate Clinical Trial
Official title:
The Effects of Sulforaphane in Patients With Biochemical Recurrence of Prostate Cancer
Verified date | April 2017 |
Source | OHSU Knight Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | May 2013 |
Est. primary completion date | May 2012 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | OHSU Knight Cancer Institute | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
OHSU Knight Cancer Institute | The Wayne D. Kuni and Joan E. Kuni Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of Patients Who Achieve a 50% Decline in Prostate-Specific Antigen (PSA) Levels | To determine the proportion of patients who achieve a decline in PSA levels while receiving sulforaphane treatment. as a measure of anti-tumor activity in men with recurrent prostate cancer. | Less than or equal to 20 weeks of sulforaphane treatment. | |
Secondary | Percent Change in PSA From Baseline to Final Measured Value at End of Study | To determine the percentage change in PSA from baseline to the final measured value at the end of study. | Measure at baseline and after stopping study treatment (less than or equal to 20 weeks of treatment with sulforaphane.) | |
Secondary | Minimum Percent Change in PSA (i.e., the Smallest Increase for Those With Increased PSA and the Greatest Decline for Those With Decreased PSA) | PSA measured every 28 days while on study treatment, an average of 5 months | ||
Secondary | Proportion of Patients Whose PSA Levels Have Not Doubled | While on treatment with sulforaphane (less than or equal to 20 weeks.) | ||
Secondary | Incidence of Grade 3 or Higher Treatment Related Toxicity | Toxicities will be graded based on the NIH Cancer Therapy Evaluation Program (CTEP) Common Toxicity Criteria of Adverse Events Version 4.0 (http://ctep.cancer.gov). All adverse events of any grade (for example, abnormal laboratory values, etc.) deemed clinically significant by the investigator will be recorded as a measure of the safety profile of sulforaphane | Continually through study and 14-30 days after last drug dose. | |
Secondary | Half-life of Sulforaphane (SFN) in Blood | Day 1 of study treatment | ||
Secondary | Half-life of SFN in Blood Among Patients With Glutathione-S-Transferase Mu 1 (GSTM1) Null Genotype | Day 1 of study treatment | ||
Secondary | Half-life of SFN in Blood Among Patients With Glutathione-S-Transferase Mu 1 (GSTM1) Intact Genotype | Day 1 of study treatment |
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