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

Recurrent Prostate Carcinoma Clinical Trial

Official title:

Phase I Study of Hyperthermia Combined With High Dose Rate Salvage Radiotherapy for the Treatment of Radiation Recurrent Prostate Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02899221
• Other study ID #: 16D.246
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 21, 2017
• Est. completion date: August 18, 2024

Study information

• Verified date: June 2024
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3
• Est. completion date: August 18, 2024
• Est. primary completion date: August 18, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperthermia
• Recurrence
• Recurrent Prostate Carcinoma

Intervention

Radiation:
• High-Dose Rate Brachytherapy
Undergo high dose rate brachytherapy

Procedure:
• Hyperthermia Treatment
Undergo interstitial hyperthermia treatment

Other:
• Laboratory Biomarker Analysis
Correlative studies

Locations

Country	Name	City	State
United States	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 90 days
Secondary	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.	Up to 5 years
Secondary	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)		Up to 5 years

External Links

•   Thomas Jefferson University Hospital