Clinical Trials /

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

NCT02899221

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.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

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

NameTypeDescriptionInterventions
Treatment (high dose rate brachytherapy, hyperthermia)ExperimentalPatients 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:Recruiting
    Lead Sponsor:Sidney Kimmel Cancer Center at Thomas Jefferson University

    Last Updated

    February 20, 2019