Sulforaphane in Treating Patients With Recurrent Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
The Wayne D. Kuni and Joan E. Kuni Foundation
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT01228084
First received: October 19, 2010
Last updated: January 14, 2014
Last verified: January 2014
Results First Received: November 5, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Adenocarcinoma of the Prostate
Recurrent Prostate Cancer
Interventions: Drug: Sulforaphane
Other: Laboratory biomarker analysis
Other: Pharmacological study

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Sulforaphane  
STARTED     20  
COMPLETED     16  
NOT COMPLETED     4  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Baseline Measures
    Sulforaphane  
Number of Participants  
[units: participants]
  20  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     4  
>=65 years     16  
Age  
[units: years]
Mean ± Standard Deviation
  70.6  ± 6.8  
Gender  
[units: participants]
 
Female     0  
Male     20  
Region of Enrollment  
[units: participants]
 
United States     20  



  Outcome Measures
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1.  Primary:   Proportion of Patients Who Achieve a 50% Decline in Prostate-Specific Antigen (PSA) Levels   [ Time Frame: Less than or equal to 20 weeks of sulforaphane treatment. ]

2.  Secondary:   Percent Change in PSA From Baseline to Final Measured Value at End of Study   [ Time Frame: Measure at baseline and after stopping study treatment (less than or equal to 20 weeks of treatment with sulforaphane.) ]

3.  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)   [ Time Frame: PSA measured every 28 days while on study treatment, an average of 5 months ]

4.  Secondary:   Proportion of Patients Whose PSA Levels Have Not Doubled   [ Time Frame: While on treatment with sulforaphane (less than or equal to 20 weeks.) ]

5.  Secondary:   Incidence of Grade 3 or Higher Treatment Related Toxicity   [ Time Frame: Continually through study and 14-30 days after last drug dose. ]

6.  Secondary:   Half-life of Sulforaphane (SFN) in Blood   [ Time Frame: Day 1 of study treatment ]

7.  Secondary:   Half-life of SFN in Blood Among Patients With Glutathione-S-Transferase Mu 1 (GSTM1) Null Genotype   [ Time Frame: Day 1 of study treatment ]

8.  Secondary:   Half-life of SFN in Blood Among Patients With Glutathione-S-Transferase Mu 1 (GSTM1) Intact Genotype   [ Time Frame: Day 1 of study treatment ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Joshi Alumkal, MD
Organization: Oregon Health & Science University, Knight Cancer Institute
phone: 503-494-1091


No publications provided


Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT01228084     History of Changes
Other Study ID Numbers: 6613, SOL-10082-L, 6613
Study First Received: October 19, 2010
Results First Received: November 5, 2013
Last Updated: January 14, 2014
Health Authority: United States: Food and Drug Administration