This trial is active, not recruiting.

Condition prostate cancer
Treatments hyperthermia treatment, radiation therapy
Phase phase 2
Sponsor Dana-Farber Cancer Institute
Collaborator National Cancer Institute (NCI)
Start date April 1997
Trial size 65 participants
Trial identifier NCT00003045, CDR0000065679, DFCI-94153, NCI-H97-1294


RATIONALE: Hyperthermia therapy may kill prostate cancer cells by heating them to several degrees above body temperature. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining hyperthermia with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of hyperthermia plus radiation therapy in treating patients who have nonmetastatic advanced prostate cancer.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Primary purpose treatment

Eligibility Criteria

Male participants at least 18 years old.

DISEASE CHARACTERISTICS: - Histologically proven prostate cancer; stage T2a, T2b, or T3a disease as defined by 1997 (current) AJCC criteria - No metastatic disease PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-1 Life expectancy: - At least 5 years unless due to prostate cancer Hematopoietic: - WBC greater than 4000/mm3 - Platelet count greater than 100,000/mm3 - Hematocrit greater than 30% Hepatic: - Not specified Renal: - Not specified Cardiovascular: - No myocardial infarction within past 6 months - No unstable angina pectoris with medication - Diastolic BP no greater than 100 mm Hg - No pacemaker - No congestive heart failure requiring medication - No evidence of vasculopathy Neurologic: - No evidence of neuropathy Pulmonary: - No severe chronic obstructive pulmonary disease (FEV1 less than 50% of predicted or less than 1 liter) Other: - No prior or concurrent malignancy except nonmelanoma skin cancer - No severe, insulin dependent diabetes mellitus - No severe cerebrovascular disease PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy Endocrine therapy: - Up to 2 months of prior neoadjuvant hormonal therapy allowed Radiotherapy: - No prior pelvic radiotherapy Surgery: - Not specified Other: - No anti-arrhythmic drugs

Additional Information

Official title A Phase II Trial of Hyperthermia and Radiotherapy for Locally Advanced Adenocarcinoma of the Prostate
Description OBJECTIVES: - Evaluate the efficacy of hyperthermia and radiation therapy in patients with locally advanced prostate cancer. - Evaluate the acute and long term toxicities of these therapies in this patient population. OUTLINE: Patients are treated with external beam irradiation 5 days a week for a total of approximately 7 weeks. Hyperthermia treatment is given twice in the first 4 weeks of radiation therapy, preferably early in the course of radiation. Hyperthermia treatments are only given once a week. A transrectal ultrasound applicator is used to deliver the hyperthermia treatment. Patients are followed every three months for 2 years, and every 6 months thereafter. PROJECTED ACCRUAL: Approximately 65 patients will be accrued over 2 years.
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).