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A Phase II Trial of Hyperthermia and Radiotherapy for Locally Advanced Adenocarcinoma of the Prostate


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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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 TherapyBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115