Trial Outcomes & Findings for Sulforaphane in Treating Patients With Recurrent Prostate Cancer (NCT NCT01228084)

NCT ID: NCT01228084

Last Updated: 2017-04-28

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 20 participants
• Primary outcome timeframe: Less than or equal to 20 weeks of sulforaphane treatment.
• Results posted on: 2017-04-28

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	20
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sulforaphane in Treating Patients With Recurrent Prostate Cancer

Baseline characteristics by cohort

Measure	Sulforaphane n=20 Participants 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.
Age, Continuous	70.6 years STANDARD_DEVIATION 6.8 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	16 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Less than or equal to 20 weeks of sulforaphane treatment.

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.

Outcome measures

Measure	Sulforaphane n=20 Participants 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.
Proportion of Patients Who Achieve a 50% Decline in Prostate-Specific Antigen (PSA) Levels	5 percentage of participants

SECONDARY outcome

Timeframe: Measure at baseline and after stopping study treatment (less than or equal to 20 weeks of treatment with sulforaphane.)

To determine the percentage change in PSA from baseline to the final measured value at the end of study.

Outcome measures

Measure	Sulforaphane n=20 Participants 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.
Percent Change in PSA From Baseline to Final Measured Value at End of Study	35 Percent change Interval -32.0 to 152.0

SECONDARY outcome

Timeframe: PSA measured every 28 days while on study treatment, an average of 5 months

Outcome measures

Measure	Sulforaphane n=20 Participants 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.
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 percent change Interval -71.0 to 48.0

SECONDARY outcome

Timeframe: While on treatment with sulforaphane (less than or equal to 20 weeks.)

Outcome measures

Measure	Sulforaphane n=20 Participants 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.
Proportion of Patients Whose PSA Levels Have Not Doubled	90 percentage of participants

SECONDARY outcome

Timeframe: Continually through study and 14-30 days after last drug dose.

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

Outcome measures

Measure	Sulforaphane n=20 Participants 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.
Incidence of Grade 3 or Higher Treatment Related Toxicity	0 participants

SECONDARY outcome

Timeframe: Day 1 of study treatment

Outcome measures

Measure	Sulforaphane n=20 Participants 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.
Half-life of Sulforaphane (SFN) in Blood	2.2 hours Interval 1.8 to 5.5

SECONDARY outcome

Timeframe: Day 1 of study treatment

Outcome measures

Measure	Sulforaphane n=8 Participants 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.
Half-life of SFN in Blood Among Patients With Glutathione-S-Transferase Mu 1 (GSTM1) Null Genotype	2.6 Hours Interval 2.0 to 5.5

SECONDARY outcome

Timeframe: Day 1 of study treatment

Outcome measures

Measure	Sulforaphane n=12 Participants 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.
Half-life of SFN in Blood Among Patients With Glutathione-S-Transferase Mu 1 (GSTM1) Intact Genotype	2.1 hours Interval 1.8 to 2.9

Adverse Events

Sulpforaphane

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Sulpforaphane n=20 participants at risk 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
Gastrointestinal disorders Bloating	20.0% 4/20
Gastrointestinal disorders Diarrhea	20.0% 4/20
Gastrointestinal disorders Dyspepsia	20.0% 4/20
Gastrointestinal disorders Flatulence	35.0% 7/20
Gastrointestinal disorders Gatrointestinal pain	15.0% 3/20
Gastrointestinal disorders Nausea	35.0% 7/20

Additional Information

Joshi Alumkal, MD

Oregon Health & Science University, Knight Cancer Institute

Phone: 503-494-1091

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place