Bethesda, Maryland 20892

  • Prostate Cancer

Purpose:

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Imaging procedures, such as MRI, may help the doctor send x-rays directly to the tumor and nearby lymph nodes and cause less damage to normal tissue. PURPOSE: This phase I trial is studying the side effects and best dose of MRI-guided radiation therapy in treating patients with prostate cancer.


Study summary:

OBJECTIVES: - Determine the feasibility of treating the pelvic lymph nodes in patients with prostate cancer treated with intensity-modulated radiotherapy (IMRT). - Determine the maximum tolerated dose of IMRT in these patients. - Determine long term effects and toxicity in patients treated with IMRT. OUTLINE: This is a pilot, dose-escalation study. After pathology is available and 2 months of neoadjuvant hormone therapy is complete, patients undergo MRI-guided intensity-modulated radiotherapy (IMRT) to the at-risk or positive lymph nodes 5 days a week for 8.5 weeks. Cohorts of 3-6 patients receive escalating doses of IMRT until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. After completion of study treatment, patients are followed periodically for 3 years. PROJECTED ACCRUAL: A total of 88 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the prostate - Risk of lymph node metastasis ≥ 10% OR biopsy-proven positive lymph nodes - No metastatic disease beyond the pelvis - Tumor visible on MRI PATIENT CHARACTERISTICS: - ECOG performance status 0-2 - No bleeding disorders - PT and PTT < 1.5 times upper limit of normal - Platelet count > 50,000/mm^3 - No artificial heart valve - Weight ≤ 136 kg - No allergy to magnetic resonance contrast agent - No pacemakers, cerebral aneurysm clips, shrapnel injury, or implantable electronic devices - No pre-existing or active prostatitis or proctitis - No medical conditions, based on the opinion of the principal investigator, that would preclude study treatment - No cognitively impaired patients who cannot give informed consent PRIOR CONCURRENT THERAPY: - No prior surgery, radiotherapy, or chemotherapy for this cancer except for neoadjuvant hormone therapy for up to 4 months - Must receive neoadjuvant, concurrent, and adjuvant hormone therapy - Must receive a nonsteroidal anti-androgen, such as flutamide, for approximately 6-8 weeks prior to starting radiotherapy - Must receive a gonadotropin releasing-hormone agonist for concurrent and adjuvant therapy - Adjuvant therapy continues for 3 years or indefinitely - No other concurrent surgery except standard biopsy - No concurrent cytotoxic chemotherapy


NCT ID:

NCT00278356


Primary Contact:

Principal Investigator
Aradhana Kaushal, MD
National Cancer Institute (NCI)


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States

Clinical Trials Office - Warren Grant Magnusen Clinical Center
Phone: 888-NCI-1937

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 27, 2022

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