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| ID | Type | Description | Link |
|---|---|---|---|
| SOL-10082-L | Other Identifier | OHSU Knight Cancer Institute | |
| 6613 | Other Identifier | OHSU IRB |
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| Name | Class |
|---|---|
| The Wayne D. Kuni and Joan E. Kuni Foundation | OTHER |
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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.
PRIMARY OBJECTIVES:
I. To determine the proportion of patients who achieve a 50% decline in prostate-specific antigen (PSA) levels within 20 weeks of sulforaphane treatment.
SECONDARY OBJECTIVES:
I. To determine the percentage change in PSA from baseline to the final measured value at the end of study as well as the maximal PSA decline that occurs while on study for each subject.
II. To determine the proportion of patients whose PSA has not doubled after full 20 weeks of sulforaphane treatment.
III. To determine the safety profile of sulforaphane. IV. To determine the pharmacokinetics (PK) of sulforaphane and its metabolites in blood.
V. To determine the effect of sulforaphane supplementation on target pharmacodynamic (PD) modulation in peripheral blood cells.
VI. To assess the effect of Glutathione-S-Transferase Mu 1 (GSTM1) genotype on sulforaphane PK, PD.
VII. To collect frozen serum for future analysis of correlative biomarkers.
OUTLINE:
Patients receive sulforaphane orally (PO) once daily for 20 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 14-30 days and every 6 months for 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sulforaphane | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sulforaphane | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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.) |
| Minimum Percent Change in PSA (i.e., the Smallest Increase for Those With Increased PSA and the Greatest Decline for Those With Decreased PSA) |
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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
Eastern Cooperative Oncology Group (ECOG) performance status <= 2
The following laboratory results within 4 weeks prior to starting study treatment:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Joshi J Alumkal, MD | OHSU Knight Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHSU Knight Cancer Institute | Portland | Oregon | 97239 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sulforaphane | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sulforaphane | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | percentage of participants | Less than or equal to 20 weeks of sulforaphane treatment. |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sulpforaphane | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bloating | Gastrointestinal disorders | CTCAE v4 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joshi Alumkal, MD | Oregon Health & Science University, Knight Cancer Institute | 503-494-1091 |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C016766 | sulforaphane |
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| Laboratory biomarker analysis | Other | Correlative studies |
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| Pharmacological study | Other | Correlative studies |
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| PSA measured every 28 days while on study treatment, an average of 5 months |
| Proportion of Patients Whose PSA Levels Have Not Doubled | While on treatment with sulforaphane (less than or equal to 20 weeks.) |
| 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. |
| Half-life of Sulforaphane (SFN) in Blood | Day 1 of study treatment |
| Half-life of SFN in Blood Among Patients With Glutathione-S-Transferase Mu 1 (GSTM1) Null Genotype | Day 1 of study treatment |
| Half-life of SFN in Blood Among Patients With Glutathione-S-Transferase Mu 1 (GSTM1) Intact Genotype | Day 1 of study treatment |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| 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. | Posted | Median | Full Range | Percent change | Measure at baseline and after stopping study treatment (less than or equal to 20 weeks of treatment with sulforaphane.) |
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| 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) | Posted | Median | Full Range | percent change | PSA measured every 28 days while on study treatment, an average of 5 months |
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| Secondary | Proportion of Patients Whose PSA Levels Have Not Doubled | Posted | Number | percentage of participants | While on treatment with sulforaphane (less than or equal to 20 weeks.) |
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| 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 | Posted | Number | participants | Continually through study and 14-30 days after last drug dose. |
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| Secondary | Half-life of Sulforaphane (SFN) in Blood | Posted | Median | Full Range | hours | Day 1 of study treatment |
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| Secondary | Half-life of SFN in Blood Among Patients With Glutathione-S-Transferase Mu 1 (GSTM1) Null Genotype | Posted | Median | Full Range | Hours | Day 1 of study treatment |
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| Secondary | Half-life of SFN in Blood Among Patients With Glutathione-S-Transferase Mu 1 (GSTM1) Intact Genotype | Posted | Median | Full Range | hours | Day 1 of study treatment |
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| 0 |
| 20 |
| 15 |
| 20 |
| Diarrhea | Gastrointestinal disorders | CTCAE v4 |
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| Dyspepsia | Gastrointestinal disorders | CTCAE v4 |
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| Flatulence | Gastrointestinal disorders | CTCAE v4 |
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| Gatrointestinal pain | Gastrointestinal disorders | CTCAE v4 |
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| Nausea | Gastrointestinal disorders | CTCAE v4 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |