Know Cancer

or
forgot password

The Effects of Sulforaphane in Patients With Biochemical Recurrence of Prostate Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Adenocarcinoma of the Prostate, Recurrent Prostate Cancer

Thank you

Trial Information

The Effects of Sulforaphane in Patients With Biochemical Recurrence of Prostate Cancer


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 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.


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

- For post surgical patients: the nadir reference value (#1) is the last PSA
measured before increases are documented, with subsequent values obtained a
minimum of 1 week apart; if the PSA at time point 3 (value #3A) is greater than
that at point 2, then eligibility has been met; if the PSA is not greater than
point 2 (value #3B), but value #4 is, the patient is eligible assuming that
other criteria are met and values 3A or #4 are 1.0 ng/mL or higher

- For post radiation therapy patients: the nadir reference value (#1) is the last
PSA measured before increases are documented, with subsequent values obtained a
minimum of 1 week apart; if the PSA at time point 3 (value #3A) is greater than
that at point 2, then eligibility has been met; if the PSA is not greater than
point 2 (value #3B), but value #4 is, the patient is eligible assuming that
other criteria are met and if values 3A or #4 are 2.0 ng/mL or more above the
nadir reference value (#1) according to Phoenix/American Society for Therapeutic
Radiology and Oncology (ASTRO) criteria

- Eastern Cooperative Oncology Group (ECOG) performance status <= 2

- The following laboratory results within 4 weeks prior to starting study treatment:

- White blood cells (WBC) >= 3000/mm^3

- Neutrophil >= 1,500/mm^3

- Platelet >= 100,000/mm^3

- Serum creatinine =< upper limit of normal (ULN)

- Albumin > 3.0 gm/dL

- Total bilirubin < 1.5 X ULN

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 1.5 X ULN

- Testosterone level >= 150ng/dL, and no evidence of progression while on prior
hormonal therapy, if applicable (i.e. patient must be non-castrate resistant).

- 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:

- Significant active medical illness which in the opinion of the investigator would
preclude protocol treatment

- Measurable and/or evaluable recurrent prostate cancer by imaging (CT scan of the
chest, abdomen, and pelvis and bone scan performed within 12 weeks prior to starting
treatment) or by physical exam

- Prior investigational therapy within 30 days prior to starting study treatment

- Prior treatment with a known histone deacetylase inhibitor (including but not limited
to valproic acid, suberoylanilide hydroxamic acid [SAHA], LBH589, etc) within 6
months prior to starting study treatment or while on study therapy

- Concurrent systemic treatment for prostate cancer

- Current treatment with warfarin

- Gastrointestinal ailments which would interfere with the ability to adequately absorb
sulforaphane

- Allergy to cruciferous vegetables

- Any condition which, in the opinion of the study clinician, would make participation
in the study harmful to the patient

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of patients who achieve a 50% decline in Prostate-Specific Antigen (PSA) levels treatment.

Outcome Description:

To determine the proportion of patients who achieve a decline in PSA levels within 20 weeks of sulforaphane treatment as a measure of anti-tumor activity in men with recurrent prostate cancer.

Outcome Time Frame:

Within 20 weeks of sulforaphane

Safety Issue:

No

Principal Investigator

Joshi J Alumkal, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

OHSU Knight Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

6613

NCT ID:

NCT01228084

Start Date:

November 2010

Completion Date:

May 2013

Related Keywords:

  • Adenocarcinoma of the Prostate
  • Recurrent Prostate Cancer
  • sulforaphane
  • broccoli sprout extract (BSE)
  • prostate cancer
  • recurrent prostate cancer
  • phase II
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms

Name

Location

OHSU Knight Cancer InstitutePortland, Oregon  97239