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Phase I Study of Bioresponse-dim in Non-Metastatic, Hormone-Refractory Prostate Cancer Patients With Rising Serum PSA

Phase 1
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

Phase I Study of Bioresponse-dim in Non-Metastatic, Hormone-Refractory Prostate Cancer Patients With Rising Serum PSA



- Establish the maximum tolerated dose, dose-limiting toxicity, and a recommended phase
II dose of absorption-enhanced diindolylmethane (BioResponse-DIM^® [BR-DIM]) in
patients with nonmetastatic, hormone-refractory prostate cancer and rising serum
prostate-specific antigen (PSA) levels.

- Evaluate the toxicities of BR-DIM.


- Evaluate the plasma pharmacokinetics of twice daily oral administration of BR-DIM in
this patient population.

- Evaluate the effect of BR-DIM supplementation on serum PSA level.

- Correlate changes in expression levels of lymphocytes NF-kB with serum PSA levels in
patients taking BR-DIM supplementation.

- Determine quality of life measures in patients taking BR-DIM supplementation.

OUTLINE: This is an open-label, dose-escalation study.

Patients receive oral absorption-enhanced absorption-enhanced diindolylmethane
(BioResponse-DIM^® [BR-DIM]) twice daily on days 1-28. Treatment repeats every 28 days for
up to 12 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of BR-DIM until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients
experience dose-limiting toxicity. At least 6 patients are treated at the MTD.

Quality of life is assessed at baseline, on day 1 of each course, and at the completion of
study therapy.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

Inclusion Criteria


- Histologically proven adenocarcinoma of the prostate

- Prostate specific antigen (PSA)-only failure after local therapy (surgery, radiation
therapy, brachytherapy, or cryotherapy)

- Rising PSA despite androgen-deprivation therapy with castrate levels of testosterone
(< 50 ng/dL)

- Two successive rising PSA levels at least 1 week apart

- PSA ≥ 5 ng/mL

- Patients with a history of combined hormonal therapy must continue
luteinizing-hormone releasing-hormone agonist treatment but must demonstrate rising
PSA after anti-androgen withdrawal

- No evidence of distant metastasis by bone scan and CT scan

- No known brain metastases requiring active therapy


- ECOG performance status ≤ 3

- Life expectancy ≥ 12 weeks

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 8.0 g/dL

- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

- SGOT and/or SGPT ≤ 2.5 times ULN AND alkaline phosphatase normal OR alkaline
phosphatase ≤ 4 times ULN AND SGOT and/or SGPT normal

- Creatinine clearance ≥ 60 mL/min OR creatinine normal

- Fertile patients must use effective contraception

- None of the following conditions within the past 6 months:

- Myocardial infarction

- Severe or unstable angina

- Symptomatic congestive heart failure

- Cerebrovascular accident or transient ischemic attack

- Coronary/peripheral artery bypass grafting

- No other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that would preclude study participation


- See Disease Characteristics

- At least 28 days since prior radiotherapy

- At least 28 days since prior investigational agents for treatment of prostate cancer

- At least 4 weeks since prior flutamide

- At least 6 weeks since prior bicalutamide

- No other concurrent antineoplastic agents

- No concurrent warfarin-related anticoagulants

- No concurrent proton-pump inhibitor drugs for gastroesophageal reflux disease (e.g.,
rabeprazole, esomeprazole magnesium, lansoprazole, omeprazole, or pantoprazole

- No concurrent micronutrient supplements or dietary soy products

- One daily multivitamin allowed

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose during study and for 30 days after

Safety Issue:


Principal Investigator

Elisabeth I. Heath, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute


United States: Federal Government

Study ID:




Start Date:

August 2005

Completion Date:

September 2010

Related Keywords:

  • Prostate Cancer
  • recurrent prostate cancer
  • stage I prostate cancer
  • stage II prostate cancer
  • stage III prostate cancer
  • adenocarcinoma of the prostate
  • stage IV prostate cancer
  • Prostatic Neoplasms



Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
Weisberg Cancer Treatment Center Detroit, Michigan  48334