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

Primary Purpose

Recurrent Prostate Carcinoma

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

High-Dose Rate Brachytherapy

Hyperthermia Treatment

Laboratory Biomarker Analysis

About this trial

This is an interventional treatment trial for Recurrent Prostate Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Sidney Kimmel Cancer Center at Thomas Jefferson University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (high dose rate brachytherapy, hyperthermia)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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)

Full Information

NCT ID

NCT02899221

First Posted

September 8, 2016

Last Updated

September 29, 2023

Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University

1. Study Identification

Unique Protocol Identification Number

NCT02899221

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

March 21, 2017 (Actual)

Primary Completion Date

August 18, 2024 (Anticipated)

Study Completion Date

August 18, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent Prostate Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment (high dose rate brachytherapy, hyperthermia)

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

High-Dose Rate Brachytherapy

Other Intervention Name(s)

Brachytherapy, High Dose, HDR, High dose brachytherapy (procedure)

Intervention Description

Undergo high dose rate brachytherapy

Intervention Type

Procedure

Intervention Name(s)

Hyperthermia Treatment

Other Intervention Name(s)

Clinical Hyperthermia, Diathermy, Hyperthermia, Hyperthermia Therapy

Intervention Description

Undergo interstitial hyperthermia treatment

Intervention Type

Other

Intervention Name(s)

Laboratory Biomarker Analysis

Intervention Description

Correlative studies

Primary Outcome Measure Information:

Title

Description

Will be computed with the corresponding 90% exact binomial confidence intervals.

Time Frame

Up to 90 days

Secondary Outcome Measure Information:

Title

Incidence of long-term toxicity associated with combined salvage high dose rate (HDR) brachytherapy and interstitial hyperthermia

Description

Will be computed with the corresponding 90% exact binomial confidence intervals.

Time Frame

Up to 5 years

Title

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)

Time Frame

Up to 5 years

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adam Mueller, MD

Organizational Affiliation

Thomas Jefferson University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sidney Kimmel Cancer Center at Thomas Jefferson University

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

12. IPD Sharing Statement

Links:

URL

http://hospitals.jefferson.edu/

Description

Thomas Jefferson University Hospital

Learn more about this trial

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

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