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

NCT ID: NCT00003045

Last Updated: 2017-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-04-30
• Study Completion Date: 2003-12-31

Brief Summary

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.

Detailed 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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hyperthermia

XRT and Hyperthermia Post-therapy evaluation PSA, Clinical Exam, and Prostate Biopsy ( @ 12 Months)

Group Type: EXPERIMENTAL

Hyperthermia

Intervention Type: DEVICE

Hyperthermia is delivered by the transrectal ultrasound applicator just prior to XRT, at least one week apart, during the first 4 weeks of XRT. The goal of hyperthermia is CEM T 90 43 greater than or equal to 10 minutes. The maximum applied power duration will be 120 minutes per treatment session

XRT

Intervention Type: RADIATION

external beam radiation to a dose of 4500 cGy to a small pelvic field, followed by a boost to a reduced volume for an additional 2160 cGy. XRT is given daily, 5 days a week for 180 cGy per day. Total radiation dose=6660cGy

Interventions

Hyperthermia

Hyperthermia is delivered by the transrectal ultrasound applicator just prior to XRT, at least one week apart, during the first 4 weeks of XRT. The goal of hyperthermia is CEM T 90 43 greater than or equal to 10 minutes. The maximum applied power duration will be 120 minutes per treatment session

Intervention Type: DEVICE

XRT

external beam radiation to a dose of 4500 cGy to a small pelvic field, followed by a boost to a reduced volume for an additional 2160 cGy. XRT is given daily, 5 days a week for 180 cGy per day. Total radiation dose=6660cGy

Intervention Type: RADIATION

Other Intervention Names

Radiation Therapy

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Irving Kaplan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Irving Kaplan, MD

Role: STUDY_CHAIR

Beth Israel Deaconess Medical Center

Locations

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

References

Hurwitz MD, Kaplan ID, Hansen JL, Prokopios-Davos S, Topulos GP, Wishnow K, Manola J, Bornstein BA, Hynynen K. Association of rectal toxicity with thermal dose parameters in treatment of locally advanced prostate cancer with radiation and hyperthermia. Int J Radiat Oncol Biol Phys. 2002 Jul 15;53(4):913-8. doi: 10.1016/s0360-3016(02)02809-2.

Reference Type: BACKGROUND

PMID: 12095557 (View on PubMed)

Hurwitz MD, Kaplan ID, Svensson GK, Hynynen K, Hansen MS. Feasibility and patient tolerance of a novel transrectal ultrasound hyperthermia system for treatment of prostate cancer. Int J Hyperthermia. 2001 Jan-Feb;17(1):31-7. doi: 10.1080/02656730150201570.

Reference Type: BACKGROUND

PMID: 11212878 (View on PubMed)

Other Identifiers

P30CA006516

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-H97-1294

Identifier Type: -

Identifier Source: secondary_id

94-153

Identifier Type: -

Identifier Source: org_study_id