NCT02899221Completed
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
Source: ClinicalTrials.gov · Last updated 20 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 3 (actual)
- First submitted
- 8 Sept 2016
- Start date
- 21 Mar 2017
- Primary completion date
- 29 Oct 2025
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Diseases
- Prostate cancer
- NCT number
- NCT02899221
What you commit to
- Study type: Interventional
- Participants enrolled: 3
- From 21 Mar 2017 to the primary completion date, 29 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior thermal ablative therapy for prostate cancer (e.g. high-intensity focused ultrasound \[HIFU\] or cryoablation)
Other illness
- 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)
- 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)
Other
- Mental incompetence or criminal incarceration
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sidney Kimmel Cancer Center at Thomas Jefferson University Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.