Pilot Study of a Catheter-based Ultrasound Hyperthermia System

University of California San Francisco (UCSF)

Status: Terminated

Conditions: Prostate Cancer; Cervical Cancer

Treatments: Procedure: Hyperthermia; Radiation: HDR brachytherapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00911079

5R01CA122276 (U.S. NIH Grant/Contract)

CDR0000643085

08992 (Other Identifier)

Details and patient eligibility

About

RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above normal body temperature. Ultrasound energy may be able to kill tumor cells by heating up the tumor cells without affecting the surrounding tissue. Implant radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving ultrasound hyperthermia therapy after implant radiation therapy may kill more tumor cells.

PURPOSE: This clinical trial is studying ultrasound hyperthermia therapy to see how well it works after implant radiation therapy in treating patients with Stage III/IV cancer of the cervix or prostate cancer with a rising prostate specific antigen (PSA) after prior local therapy.

Full description

OUTLINE: Patients undergo standard high-dose rate (HDR) brachytherapy. Approximately 2 hours after brachytherapy, patients undergo catheter-based ultrasound hyperthermia therapy over 60 minutes. Treatment with HDR brachytherapy and hyperthermia therapy repeats within 1-3 weeks. Patients may then undergo 2 additional standard HDR brachytherapy sessions.

After completion of study therapy, patients are followed at 1 and 3 months.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who are to be given HDR brachytherapy for treatment of solid tumor of the following:

  • Cervical cancer Stage III or IV OR
  • Prostate cancer (with rising prostate specific antigen after prior local therapy)

• Age >=18 years

• Eligible for brachytherapy as determined per clinical standard of care.

• Ability to give written informed consent and willingness to comply with the requirements of the protocol

Exclusion criteria

• Patients who are not candidates for HDR brachytherapy
• Any condition that compromises compliance with the objectives and procedures of this protocol, as judged by the principal investigator

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Hyperthermia with HDR brachytherapy

Experimental group

Description:

Hyperthermia will be delivered within approximately 2 hours of (HDR) brachytherapy associated with the implant session

Treatment:

Radiation: HDR brachytherapy

Procedure: Hyperthermia