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| ID | Type | Description | Link |
|---|---|---|---|
| JT 8400 | Other Identifier | JeffTrial Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (high dose rate brachytherapy, hyperthermia) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-Dose Rate Brachytherapy | Radiation | Undergo high dose rate brachytherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Will be computed with the corresponding 90% exact binomial confidence intervals. | Up to 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of long-term toxicity associated with combined salvage high dose rate (HDR) brachytherapy and interstitial hyperthermia | Will be computed with the corresponding 90% exact binomial confidence intervals. | Up to 5 years |
| Efficacy of combined salvage HDR brachytherapy and interstitial hyperthermia as defined by nadir PSA =< 0.5 mg/ml and freedom from biochemical failure per the Phoenix definition (nadir + 2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessie DiNome, MD | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Cancer Center at Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
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| Label | URL |
|---|---|
| Thomas Jefferson University Hospital | View source |
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| Hyperthermia Treatment | Procedure | Undergo interstitial hyperthermia treatment |
|
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| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Up to 5 years |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D001918 | Brachytherapy |
| D003972 | Diathermy |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D006979 | Hyperthermia, Induced |
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