Hyperthermia and High Dose Rate Radiation Therapy in Treating Patients With Recurrent Prostate Cancer After Radiation
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|ClinicalTrials.gov Identifier: NCT02899221|
Recruitment Status : Active, not recruiting
First Posted : September 14, 2016
Last Update Posted : July 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Prostate Carcinoma||Radiation: High-Dose Rate Brachytherapy Procedure: Hyperthermia Treatment||Phase 1|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Hyperthermia Combined With High Dose Rate Salvage Radiotherapy for the Treatment of Radiation Recurrent Prostate Cancer|
|Actual Study Start Date :||March 21, 2017|
|Actual Primary Completion Date :||October 18, 2019|
|Estimated Study Completion Date :||January 2022|
Experimental: 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.
Radiation: High-Dose Rate Brachytherapy
Undergo high dose rate brachytherapy
Procedure: Hyperthermia Treatment
Undergo interstitial hyperthermia treatment
- Incidence of dose limiting toxicity defined as >= grade 3 per National Cancer Institute Common Toxicity Criteria version 4 occurring within 90 days of treatment and at least possibly attributed to radiation therapy and/or hyperthermia [ Time Frame: Up to 90 days after last treatment ]
- Incidence of long-term toxicity associated with combined salvage high dose rate brachytherapy and interstitial hyperthermia [ Time Frame: Up to 5 years after last treatment ]
- Efficacy of combined salvage high dose rate brachytherapy and interstitial hyperthermia as defined by nadir PSA(prostate-specific antigen) =< 0.5 mg/ml and freedom from biochemical failure per the Phoenix definition (nadir + 2) [ Time Frame: Up to 5 years after last treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02899221
|United States, Pennsylvania|
|Sidney Kimmel Cancer Center at Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Adam Mueller, MD||Thomas Jefferson University|