Hyperthermia Plus Radiation Therapy in Treating Patients With Nonmetastatic Advanced Prostate Cancer

This study is ongoing, but not recruiting participants.
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
First received: November 1, 1999
Last updated: February 6, 2009
Last verified: November 2002

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.

Condition Intervention Phase
Prostate Cancer
Procedure: hyperthermia treatment
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Trial of Hyperthermia and Radiotherapy for Locally Advanced Adenocarcinoma of the Prostate

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 65
Study Start Date: April 1997
Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Histologically proven prostate cancer; stage T2a, T2b, or T3a disease as defined by 1997 (current) AJCC criteria
  • No metastatic disease



  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • At least 5 years unless due to prostate cancer


  • WBC greater than 4000/mm3
  • Platelet count greater than 100,000/mm3
  • Hematocrit greater than 30%


  • Not specified


  • Not specified


  • 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


  • No evidence of neuropathy


  • No severe chronic obstructive pulmonary disease (FEV1 less than 50% of predicted or less than 1 liter)


  • No prior or concurrent malignancy except nonmelanoma skin cancer
  • No severe, insulin dependent diabetes mellitus
  • No severe cerebrovascular disease


Biologic therapy:

  • Not specified


  • No prior chemotherapy

Endocrine therapy:

  • Up to 2 months of prior neoadjuvant hormonal therapy allowed


  • No prior pelvic radiotherapy


  • Not specified


  • No anti-arrhythmic drugs
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00003045

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Joint Center for Radiation Therapy
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Study Chair: Mark Hurwitz, MD Dana-Farber Cancer Institute
  More Information

ClinicalTrials.gov Identifier: NCT00003045     History of Changes
Other Study ID Numbers: CDR0000065679  DFCI-94153  NCI-H97-1294 
Study First Received: November 1, 1999
Last Updated: February 6, 2009

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
stage II prostate cancer
stage III prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on January 19, 2017