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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2002 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003045
First received: November 1, 1999
Last updated: February 6, 2009
Last verified: November 2002
History of Changes
  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
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:

U.S. FDA Resources

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

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

No publications provided

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
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

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Fever
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
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 May 23, 2013