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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003045
  Purpose

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
Procedure: radiation therapy
Phase II

MedlinePlus related topics:   Cancer    Fever    Prostate Cancer   

U.S. FDA Resources

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

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

Estimated Enrollment:   65
Study Start Date:   April 1997

Detailed 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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003045

Locations
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)

Investigators
Study Chair:     Mark Hurwitz, MD     Dana-Farber Cancer Institute    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000065679, DFCI-94153, NCI-H97-1294
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003045
Health Authority:   United States: Federal Government

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

Study placed in the following topic categories:
Fever
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on September 16, 2008




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