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

Completed · Not applicable

Conditions studied: Prostate Cancer

In brief

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. The purpose of this study is to determine the ability of hyperthermia when combined with radiation therapy and in some patients hormonal therapy to control prostate cancer.

Key facts

Study ID

NCT00003045

Run by

Dana-Farber Cancer Institute

People needed

38

Starts

1997-04-01

Expected to finish

2003-12-31

Last updated by the study team

2017-04-26

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Histologic confirmation of prostate cancer. (Slides will be obtained for central review)
• Clinical stage T2b, T2c, T3a, or T3b disease as defined by the AJCC 4th edition staging manual (see Appendix A)
• No evidence of metastatic disease (bone, lymph node or visceral) based on bone scan and computed tomography
• Adequate hematologic function
• WBC> 4000/mm3
• platelet count > 100, 000/mm3
• hematocrit of > 30%
• An ECOG Performance Status of zero or one
• Age ≥ 18
• A life expectancy of 5 years or more(excluding possible prostate related causes)

You may not qualify if…

• Prior history of malignancy (except for non-melanoma skin cancer)
• Prior systemic therapy
• No prior chemotherapy
• No prior hormonal therapy other than that recommended in this protocol
• Prior pelvic radiotherapy
• Medical problems (such as an abnormal bleeding propensity) which would make transrectal ultrasound-directed transperineal thermal probe placement hazardous.
• Patients with severe insulin-dependent diabetes mellitus and evidence of neuropathy or vaculopathy
• Patients with unstable cardiac status including:
• Unstable angina pectoris on medication
• Patients with documented myocardial infarction within six months of protocol entry
• Congestive heart failure requiring medication
• Patients on anti-arrhythmic drugs
• Severe hypertension (diastolic BP> 100 on medication
• Patients with cardiac pacemakers
• Severe cerebrovascular disease (multiple CVA or CVA within 6 months)
• Severe COPD (medication requiring, with FEV 1 < 50% of expected or < 1 liter)
• Individuals who appear unlikely to tolerate the required prolonged stationary position during treatment due to emotional immaturity or instability or otherwise due to mental incompetence.

Where it is running

• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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