Pilot Study of a Catheter-based Ultrasound Hyperthermia System

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pilot Study of a Catheter-based Ultrasound Hyperthermia System

Conditions
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Cervical Cancer, Prostate Cancer

Intervention / Treatment
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* Procedure: Hyperthermia
* Radiation: HDR brachytherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyperthermia with HDR brachytherapy<br>Hyperthermia will be delivered within approximately 2 hours of (HDR) brachytherapy associated with the implant session | Procedure: Hyperthermia<br>* Single course of Catheter-based Ultrasound Hyperthermia (within approximately 2 hours of a Standard-of-care High Dose Rate (HDR) Brachytherapy)<br>Radiation: HDR brachytherapy<br>* Completion of standard-of-care high dose rate (HDR) Brachytherapy treatments (radiation fractions) using Session #1 catheter implants<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of treatment-related toxicities by treatment type | All patients treated with at least one hyperthermia session will be included in the safety analysis. The frequency by grade for all treatment-related adverse events will be tabulated by type as classified in NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 and presented separately for the first and second hyperthermia treatments. | Up to 3 months | 
| Frequency of treatment-related toxicities by accrual plan | All patients treated with at least one hyperthermia session will be included in the safety analysis. The frequency by grade for all treatment-related adverse events will be tabulated by type as classified in NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 presented for the 2 subsets of patients corresponding to the plan for accrual: the first 3 patients with gynecologic cancer, then the final 9 patients with gynecologic cancer; and the first 3 patients with prostate cancer, then the final 9 patients with prostate cancer | Up to 3 months | 
| Proportion of patients treated according to the specified temperature and timing criteria. | The feasibility of administering hyperthermia to patients receiving standard brachytherapy will be summarized by the proportion of patients completing the treatment as planned. The proportion and 95% confidence interval will be calculated for each of the two hyperthermia sessions | Up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average maximum prostate temperature (Tmax) | Attainable temperature and thermal dose distributions will be summarized using descriptive statistics and presented separately for each hyperthermia treatment | Up to 4 weeks | 
| Minimum temperature (Tmin) | Attainable temperature and thermal dose distributions will be summarized using descriptive statistics and presented separately for each hyperthermia treatment | Up to 4 weeks | 
| Median temperature (T50) | Attainable temperature and thermal dose distributions will be summarized using descriptive statistics and presented separately for each hyperthermia treatment | Up to 4 weeks | 
| Number of times temperature exceeded by 90% of the measured temperature points (T90) | Attainable temperature and thermal dose distributions will be summarized using descriptive statistics and presented separately for each hyperthermia treatment | Up to 4 weeks | 
| Cumulative Equivalent Minutes at 43 degree celsius (ºC) for 90% of the measured points (CEM43T90) | Attainable temperature and thermal dose distributions will be summarized using descriptive statistics and presented separately for each hyperthermia treatment | Up to 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stage III, IV cervical cancer, Rising prostate specific antigen (PSA) after local therapy