Phase 2
N=20
Sulforaphane in Treating Patients With Recurrent Prostate Cancer
Adenocarcinoma of the Prostate · Recurrent Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01228084 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: Proportion of Patients Who Achieve a 50% Decline in Prostate-Specific Antigen (PSA) Levels — 5 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sulforaphane (Drug); Laboratory biomarker analysis (Other); Pharmacological study (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- OHSU Knight Cancer Institute
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Who Achieve a 50% Decline in Prostate-Specific Antigen (PSA) Levels |
5 | — |
| SECONDARY Percent Change in PSA From Baseline to Final Measured Value at End of Study |
35 | — |
| 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) |
2 | — |
| SECONDARY Proportion of Patients Whose PSA Levels Have Not Doubled |
90 | — |
| SECONDARY Incidence of Grade 3 or Higher Treatment Related Toxicity |
— | — |
| SECONDARY Half-life of Sulforaphane (SFN) in Blood |
2.2 | — |
| SECONDARY Half-life of SFN in Blood Among Patients With Glutathione-S-Transferase Mu 1 (GSTM1) Null Genotype |
2.6 | — |
| SECONDARY Half-life of SFN in Blood Among Patients With Glutathione-S-Transferase Mu 1 (GSTM1) Intact Genotype |
2.1 | — |
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 = 3000/mm^3
- Neutrophil >= 1,500/mm^3
- Platelet >= 100,000/mm^3
- Serum creatinine = 3.0 gm/dL
- Total bilirubin = 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
Data sourced from ClinicalTrials.gov (NCT01228084). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.