Pilot Study of a Catheter-based Ultrasound Hyperthermia System

Prostate Cancer Clinical Trial

Official title:

Pilot Study of a Catheter-based Ultrasound Hyperthermia System

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00911079
• Other study ID #: CDR0000643085
• Secondary ID: 089925R01CA12227
• Status: Terminated
• Phase: N/A
• Start date: December 18, 2009
• Est. completion date: July 23, 2020

Study information

• Verified date: June 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: July 23, 2020
• Est. primary completion date: July 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Fever
• Prostate Cancer
• Uterine Cervical Neoplasms

Intervention

Procedure:
• Hyperthermia
Single course of Catheter-based Ultrasound Hyperthermia (within approximately 2 hours of a Standard-of-care High Dose Rate (HDR) Brachytherapy)

Radiation:
• HDR brachytherapy
Completion of standard-of-care high dose rate (HDR) Brachytherapy treatments (radiation fractions) using Session #1 catheter implants

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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