Clinical trial · Interventional
Diindolylmethane in Treating Patients With Nonmetastatic Prostate Cancer That Has Not Responded To Previous Hormone Therapy
Phase I Study of Bioresponse-dim in Non-Metastatic, Hormone-Refractory Prostate Cancer Patients With Rising Serum PSA
NCT00305747CI-TRIAL-00013472completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Diindolylmethane may slow the growth of prostate cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of diindolylmethane in treating patients with nonmetastatic prostate cancer that has not responded to previous hormone therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BR-DIM | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BR-DIM
- description
- BR-DIM will be administered at a starting dose of 75 mg po twice daily. Patients will be instructed to take tablets twice daily with 8 ozs. of water, with/without food. A study calendar will be provided and patients will be asked to fill the appropriate boxes when they take their study capsules. One treatment cycle is 28 days.
- interventionNames
- Drug: BR-DIM
Primary outcomes (1)
- measure
- Maximum tolerated dose (MTD), Dose limiting toxicity (DLT) & toxicities during study and for 30 days after
- timeFrame
- During study and for 30 days after
Secondary outcomes (4)
- measure
- Plasma pharmacokinetics as measured by occurrences of toxicity
- timeFrame
- At baseline; Cycle 1 Day 1 at 20, 60, 120, 180, 240, and 480 minutes
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * 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 PATIENT CHARACTERISTICS: * 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 PRIOR CONCURRENT THERAPY: * 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 sodium) * No concurrent micronutrient supplements or dietary soy products * One daily multivitamin allowed
References
Publications (0)
Data not yet available
No reference posted for this study.