NCT02899221

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

Phase I Study of Hyperthermia Combined With High Dose Rate Salvage Radiotherapy for the Treatment of Radiation Recurrent Prostate Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
RADIATION	High-Dose Rate Brachytherapy	Undergo high dose rate brachytherapy
PROCEDURE	Hyperthermia Treatment	Undergo interstitial hyperthermia treatment
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2017-03-21
• Primary completion: 2025-10-29
• Completion: 2025-10-29
• First posted: 2016-09-14
• Last updated: 2026-02-20

Locations

1 site across 1 country: United States