The Effects of Sulforaphane in Patients With Biochemical Recurrence of Prostate Cancer
| Status: | Archived |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | November 2010 |
| End Date: | November 2012 |
This is a Phase II study to examine the safety and anti-tumor activity of sulforaphane in
men with recurrent prostate cancer as evidenced by a rising PSA only after primary treatment
of localized prostate cancer.
Patients who are eligible will undergo 20 full weeks of treatment with sulforaphane. A
single 200µmol dose of the drug (names: Broccoli Sprout Extract (BSE) or sulforaphane) will
be given daily, and patients will have extensive Pharmacokinetic (PK) sampling on day 1 of
the first week. In the absence of a required dose reduction due to toxicity, patients will
continue on the same dose once daily from Week 1 Day 1 to Week 20 Day 7. The last scheduled
study drug dose will be taken on the day prior to Week 21, Day 1.
Prostate cancer is the most common cancer in men in the United States. Despite early
identification of this disease through screening, 50,000 men were estimated to recur and
27,000 men were estimated to die despite early, local treatments last year. This
underscores the need to identify safe and effective treatments for men with prostate cancer
and those at risk of its development. The rationale for focusing on sulforaphane in this
group of patients is due to:
1) the epidemiologic data reporting an inverse association between high intake of
cruciferous vegetables, from which sulforaphane is derived, and risk of prostate cancer, 2)
the wealth of pre-clinical data for sulforaphane's effects on cancer prevention and
inhibition of cancer cell growth and survival mediated via modulation of multiple critical
pathways, including our recent work that clarifies that sulforaphane disrupts AR signaling
through a unique mechanism, 3) the low likelihood of discontinuation of treatment early in
this disease state due to symptomatic disease progression, which is a common in clinical
trials in more advanced disease states, and 4) because innumerable prior studies with
sulforaphane have shown biological activity, including one in which intraprostatic
concentrations which are associated with anti-tumor activity were achieved with our proposed
dose.
This phase II trial in men with biochemically-recurrent (PSA-only recurrences) prostate
cancer tests the following central hypothesis: Sulforaphane treatment will lead to
pharmacodynamic modulation and anti-tumor activity through disruption of androgen receptor
(AR) signaling. The proposed trial will determine whether this dose is safe and effective
and will inform future preventive and therapeutic studies of sulforaphane in patients at
risk of or with established prostate cancer.
We found this trial at
1
site
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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