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

NCT02899221 | Completed DMC

• 2 other identifiers: 16D.246JT 8400
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Prostate Carcinoma

Outcome Measures

Primary Outcomes (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

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

  Up to 90 days

Secondary Outcomes (2)

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

  Up to 5 years

• 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

Study Arms (1)

Treatment (high dose rate brachytherapy, hyperthermia)

EXPERIMENTAL

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; Procedure: Hyperthermia Treatment; Other: Laboratory Biomarker Analysis

Interventions

High-Dose Rate Brachytherapy RADIATION

Undergo high dose rate brachytherapy

Also known as: Brachytherapy, High Dose, HDR, High dose brachytherapy (procedure)

Treatment (high dose rate brachytherapy, hyperthermia)

Hyperthermia Treatment PROCEDURE

Undergo interstitial hyperthermia treatment

Also known as: Clinical Hyperthermia, Diathermy, Hyperthermia, Hyperthermia Therapy

Treatment (high dose rate brachytherapy, hyperthermia)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (high dose rate brachytherapy, hyperthermia)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University: lead

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

• Thomas Jefferson University Hospital

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Brachytherapy; Diathermy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Hyperthermia, Induced

Study Officials

• Jessie DiNome, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: September 14, 2016
• Study Start: March 21, 2017
• Primary Completion: October 29, 2025
• Study Completion: October 29, 2025
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

US (1)