Description:
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.
Title
- Brief Title: Hyperthermia and High Dose Rate Radiation Therapy in Treating Patients With Recurrent Prostate Cancer After Radiation
- Official Title: Phase I Study of Hyperthermia Combined With High Dose Rate Salvage Radiotherapy for the Treatment of Radiation Recurrent Prostate Cancer
Clinical Trial IDs
- ORG STUDY ID:
16D.246
- NCT ID:
NCT02899221
Conditions
- Recurrent Prostate Carcinoma
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
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. | |
Eligibility Criteria
Inclusion Criteria:
- Karnofsky performance status > 70%
- Expected survival of at least 3 years
- Informed consent signed by the subject
- Prostate-specific antigen (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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Male |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | 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 |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | 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 |
Safety Issue: | |
Description: | |
Measure: | 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 |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Sidney Kimmel Cancer Center at Thomas Jefferson University |
Last Updated
July 20, 2021