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

NCT00003045 | Completed DMC FDA Device

• 3 other identifiers: 94-153P30CA006516NCI-H97-1294
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage II prostate cancer; stage III prostate cancer

Outcome Measures

Primary Outcomes (1)

• Time of PSA Failure

  Kaplan Meier estimation and Cox regression model

  2 Years

Secondary Outcomes (1)

• Local Control and Disease Specific survival

  One year post treatment

Study Arms (1)

Hyperthermia

EXPERIMENTAL

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

Device: Hyperthermia; Radiation: XRT

Interventions

Hyperthermia 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

Hyperthermia

XRT 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

Also known as: Radiation Therapy

Hyperthermia

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

• 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.

  PMID: 12095557 BACKGROUND

• 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.

  PMID: 11212878 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Diathermy; Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hyperthermia, Induced; Therapeutics

Study Officials

• Irving Kaplan, MD

  Beth Israel Deaconess Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: July 11, 2003
• Study Start: April 1, 1997
• Primary Completion: December 31, 2001
• Study Completion: December 31, 2003
• Last Updated: April 26, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)