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Sulforaphane in Treating Patients With Recurrent Prostate Cancer

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ClinicalTrials.gov Identifier: NCT01228084
Recruitment Status : Completed
First Posted : October 25, 2010
Results First Posted : March 3, 2014
Last Update Posted : April 28, 2017
Sponsor:
Collaborator:
The Wayne D. Kuni and Joan E. Kuni Foundation
Information provided by (Responsible Party):
Joshi Alumkal, OHSU Knight Cancer Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adenocarcinoma of the Prostate
Recurrent Prostate Cancer
Interventions Drug: Sulforaphane
Other: Laboratory biomarker analysis
Other: Pharmacological study
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sulforaphane
Hide Arm/Group 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.
Period Title: Overall Study
Started 20
Completed 16
Not Completed 4
Arm/Group Title Sulforaphane
Hide Arm/Group 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.
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4
  20.0%
>=65 years
16
  80.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
70.6  (6.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
0
   0.0%
Male
20
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
1.Primary Outcome
Title Proportion of Patients Who Achieve a 50% Decline in Prostate-Specific Antigen (PSA) Levels
Hide Description 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.
Time Frame Less than or equal to 20 weeks of sulforaphane treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane
Hide Arm/Group 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.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: percentage of participants
5
2.Secondary Outcome
Title Percent Change in PSA From Baseline to Final Measured Value at End of Study
Hide Description To determine the percentage change in PSA from baseline to the final measured value at the end of study.
Time Frame Measure at baseline and after stopping study treatment (less than or equal to 20 weeks of treatment with sulforaphane.)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane
Hide Arm/Group 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.
Overall Number of Participants Analyzed 20
Median (Full Range)
Unit of Measure: Percent change
35
(-32 to 152)
3.Secondary Outcome
Title Minimum Percent Change in PSA (i.e., the Smallest Increase for Those With Increased PSA and the Greatest Decline for Those With Decreased PSA)
Hide Description [Not Specified]
Time Frame PSA measured every 28 days while on study treatment, an average of 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane
Hide Arm/Group 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.
Overall Number of Participants Analyzed 20
Median (Full Range)
Unit of Measure: percent change
2
(-71 to 48)
4.Secondary Outcome
Title Proportion of Patients Whose PSA Levels Have Not Doubled
Hide Description [Not Specified]
Time Frame While on treatment with sulforaphane (less than or equal to 20 weeks.)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane
Hide Arm/Group 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.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: percentage of participants
90
5.Secondary Outcome
Title Incidence of Grade 3 or Higher Treatment Related Toxicity
Hide Description 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
Time Frame Continually through study and 14-30 days after last drug dose.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane
Hide Arm/Group 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.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
0
6.Secondary Outcome
Title Half-life of Sulforaphane (SFN) in Blood
Hide Description [Not Specified]
Time Frame Day 1 of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane
Hide Arm/Group 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.
Overall Number of Participants Analyzed 20
Median (Full Range)
Unit of Measure: hours
2.2
(1.8 to 5.5)
7.Secondary Outcome
Title Half-life of SFN in Blood Among Patients With Glutathione-S-Transferase Mu 1 (GSTM1) Null Genotype
Hide Description [Not Specified]
Time Frame Day 1 of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane
Hide Arm/Group 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.
Overall Number of Participants Analyzed 8
Median (Full Range)
Unit of Measure: Hours
2.6
(2.0 to 5.5)
8.Secondary Outcome
Title Half-life of SFN in Blood Among Patients With Glutathione-S-Transferase Mu 1 (GSTM1) Intact Genotype
Hide Description [Not Specified]
Time Frame Day 1 of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane
Hide Arm/Group 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.
Overall Number of Participants Analyzed 12
Median (Full Range)
Unit of Measure: hours
2.1
(1.8 to 2.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sulpforaphane
Hide Arm/Group 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
All-Cause Mortality
Sulpforaphane
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sulpforaphane
Affected / at Risk (%)
Total   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sulpforaphane
Affected / at Risk (%)
Total   15/20 (75.00%) 
Gastrointestinal disorders   
Bloating  4/20 (20.00%) 
Diarrhea  4/20 (20.00%) 
Dyspepsia  4/20 (20.00%) 
Flatulence  7/20 (35.00%) 
Gatrointestinal pain  3/20 (15.00%) 
Nausea  7/20 (35.00%) 
1
Term from vocabulary, CTCAE v4
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Joshi Alumkal, MD
Organization: Oregon Health & Science University, Knight Cancer Institute
Phone: 503-494-1091
Responsible Party: Joshi Alumkal, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT01228084     History of Changes
Other Study ID Numbers: 6613
SOL-10082-L ( Other Identifier: OHSU Knight Cancer Institute )
6613 ( Other Identifier: OHSU IRB )
First Submitted: October 19, 2010
First Posted: October 25, 2010
Results First Submitted: November 5, 2013
Results First Posted: March 3, 2014
Last Update Posted: April 28, 2017