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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02899221
Recruitment Status : Active, not recruiting
First Posted : September 14, 2016
Last Update Posted : December 21, 2022
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Recurrent Prostate Carcinoma Radiation: High-Dose Rate Brachytherapy Procedure: Hyperthermia Treatment Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 : June 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
Other Names:
  • Clinical Hyperthermia
  • Diathermy
  • Hyperthermia
  • Hyperthermia Therapy


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Pennsylvania
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
Investigators
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Principal Investigator: Adam Mueller, MD Thomas Jefferson University
More Information
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Additional Information:

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Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT02899221    
Other Study ID Numbers: 16D.246
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: December 21, 2022
Last Verified: December 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Recurrence
Hyperthermia
Disease Attributes
Pathologic Processes
 Body Temperature Changes
Heat Stress Disorders
Wounds and Injuries