A Phase II Trial of Hyperthermia and Radiotherapy for Locally Advanced Adenocarcinoma of the Prostate
18 Years
N/A
Male
Prostate Cancer
Trial Information
A Phase II Trial of Hyperthermia and Radiotherapy for Locally Advanced Adenocarcinoma of the Prostate
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Mark Hurwitz, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Dana-Farber Cancer Institute
Authority:
United States: Federal Government
Study ID:
CDR0000065679
NCT ID:
NCT00003045
Start Date:
April 1997
Completion Date:
Related Keywords:
- Prostate Cancer
- adenocarcinoma of the prostate
- stage II prostate cancer
- stage III prostate cancer
- Adenocarcinoma
- Prostatic Neoplasms
- Fever
Name | Location |
|---|---|
| Joint Center for Radiation Therapy | Boston, Massachusetts 02215 |
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
