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

Dana-Farber Cancer Institute

Status

Completed

Conditions

Prostate Cancer

Treatments

Device: Hyperthermia

Radiation: XRT

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00003045

P30CA006516 (U.S. NIH Grant/Contract)

NCI-H97-1294

94-153

Details and patient eligibility

About

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.

Full description

The purpose of this study is to determine the ability of hyperthermia (heat treatments produced by sound waves) when combined with radiation therapy and in some patients hormonal therapy to control prostate cancer.

Hyperthermia refers to the use of temperatures 42 oC (107-6oF) or higher to treatment malignant tumors. Laboratory and some clinical reports have demonstrated a tumor killing effect if tumors are heated to 43oC (109oF) for 30-60 minutes.

Many studies have shown that hyperthermia improves the killing effect of radiation treatments for many tumors. In clinical studies, the addition of hyperthermia has shown to be beneficial for tumors of the breast, urinary bladder and the head and neck region with combined with radiation therapy. Investigators found an improvement in tumor response rates and a lengthened duration of response. The proposed study is one of the first controlled studies to attempt to prove the usefulness of hyperthermia for patients with prostate cancer.

Enrollment

38 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

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)

Exclusion Criteria :

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.