Hyperthermia and High Dose Rate Radiation Therapy in Treating Patients With Recurrent Prostate Cancer After Radiation

NCT ID: NCT02899221

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-21
• Study Completion Date: 2026-02-28

Brief Summary

This phase I trial studies the side effects and best way to give hyperthermia and high dose rate radiation therapy in treating patients with prostate cancer that has come back after prior radiation treatment. Radiation therapy, such as high dose rate brachytherapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Hyperthermia therapy may make tumor cells more sensitive to the effects of radiation therapy by heating them to several degrees above normal body temperature. Giving hyperthermia and high dose rate radiation therapy may work better in treating patients with recurrent prostate cancer after radiation.

Detailed Description

PRIMARY OBJECTIVES:

I. To assess the safety and feasibility of combined single fraction high dose rate (HDR) brachytherapy followed immediately by interstitial hyperthermia treatment of radio-recurrent prostate cancer.

SECONDARY OBJECTIVES:

I. To assess long-term toxicity. II. To provide a preliminary assessment of efficacy. III. To obtain blood for future analysis of immune response to combined radiation therapy and hyperthermia.

OUTLINE:

Patients undergo high dose rate brachytherapy for 15-30 minutes. Immediately after radiation therapy (no longer than 90 minutes), patients undergo interstitial hyperthermia treatment for up to 60 minutes.

After completion of study treatment, patients are followed up at 1 week, 1 month, and every 3 months for 2 years, every 6 months for 3 years and annually thereafter.

Conditions

Recurrent Prostate Carcinoma

Study Design

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

Study Groups

Treatment (high dose rate brachytherapy, hyperthermia)

Patients undergo high dose rate brachytherapy for 15-30 minutes. Immediately after radiation therapy (no longer than 90 minutes), patients undergo interstitial hyperthermia treatment for up to 60 minutes.

Group Type: EXPERIMENTAL

High-Dose Rate Brachytherapy

Intervention Type: RADIATION

Undergo high dose rate brachytherapy

Hyperthermia Treatment

Intervention Type: PROCEDURE

Undergo interstitial hyperthermia treatment

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Interventions

High-Dose Rate Brachytherapy

Undergo high dose rate brachytherapy

Intervention Type: RADIATION

Hyperthermia Treatment

Undergo interstitial hyperthermia treatment

Intervention Type: PROCEDURE

Laboratory Biomarker Analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

Brachytherapy; High Dose; HDR; High dose brachytherapy (procedure); Clinical Hyperthermia; Diathermy; Hyperthermia; Hyperthermia Therapy

Eligibility Criteria

Inclusion Criteria

• Male age >= 18 years
• Karnofsky performance status > 70%
• Expected survival of at least 3 years
• Informed consent signed by the subject
• PSA blood test within 60 days prior to registration
• Prostate biopsy with Gleason score and TNM staging within one year prior to registration
• No evidence of metastasis on computed tomography (CT) or magnetic resonance imaging (MRI) of the pelvis within 120 days prior to registration
• No evidence of metastasis on bone scan within 120 days prior to registration
• Within 60 days prior to registration, hematologic minimal values: absolute neutrophil count > 1,500/mm^3
• Within 60 days prior to registration, hematologic minimal values: hemoglobin > 8.0 g/dl
• Within 60 days prior to registration, hematologic minimal values: platelet count > 100,000/mm^3
• Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months after completion of treatment
• Histologically proven persistent or recurrent adenocarcinoma of the prostate following prior external beam radiation therapy or brachytherapy
• Prior androgen deprivation or chemotherapy is allowed if discontinued at least 30 days prior to enrollment
• Concurrent disease - patients under treatment for concurrent medical conditions will be eligible for protocol treatment if, in the opinion of the physician responsible for hyperthermia treatment that the concurrent medical condition will neither interfere with the process of the treatment or patient assessments nor add significantly to the risks or complications of the treatment

Exclusion Criteria

• History of urological surgery or procedures predisposing to genitourinary (GU) complications after radiation, i.e., anastomoses, stricture repair, transurethral resection, etc. (will be determined by radiation oncologist)
• Prior thermal ablative therapy for prostate cancer (e.g. high-intensity focused ultrasound [HIFU] or cryoablation)
• Documented distant metastatic disease
• Patient with other co-morbidities that in the opinion of the treating physician would be a contra-indication to protocol participation (e.g. inflammatory bowel disease)
• Mental incompetence or criminal incarceration

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

Sponsors

Sidney Kimmel Cancer Center at Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessie DiNome, MD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Countries

United States

Related Links

http://hospitals.jefferson.edu/

Thomas Jefferson University Hospital

Other Identifiers

JT 8400

Identifier Type: OTHER

Identifier Source: secondary_id

16D.246

Identifier Type: -

Identifier Source: org_study_id