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Brachytherapy

Hyperthermia + Radiation for Recurrent Prostate Cancer

N/A

Waitlist Available

Led By Jessie DiNome, MD

Research Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically proven persistent or recurrent adenocarcinoma of the prostate following prior external beam radiation therapy or brachytherapy

Karnofsky performance status > 70%

Must not have

Prior thermal ablative therapy for prostate cancer (e.g. high-intensity focused ultrasound [HIFU] or cryoablation)

Documented distant metastatic disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trialstudies how to best combine radiation and heat to treat prostate cancer that has returned after prior radiation.

Who is the study for?

This trial is for men with prostate cancer that has returned after radiation. They must have a recent PSA test, biopsy, and scans showing no distant metastasis. Blood counts need to be within certain ranges, they should agree to use contraception if of childbearing potential, and not have had certain urological surgeries or thermal treatments for prostate cancer.

What is being tested?

The study is testing the combination of hyperthermia treatment (heating tumor cells) with high dose rate brachytherapy (targeted internal radiation) in patients whose prostate cancer has recurred after previous radiation therapy. The goal is to see if this approach is more effective when the two are used together.

What are the potential side effects?

Potential side effects may include discomfort from heat during hyperthermia treatment, typical risks associated with anesthesia and invasive procedures like brachytherapy such as bleeding or infection, and usual radiation side effects like fatigue, skin irritation at the treatment site, and urinary issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer has come back or continued after radiation treatment.

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I am mostly independent and can care for myself.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had treatments like HIFU or cryoablation for prostate cancer.

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My cancer has spread to distant parts of my body.

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I am not mentally competent or I am currently in jail.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Side effects data

From 2021 Phase 2 trial • 200 Patients • NCT02526498

22%

Musculoskeletal and connective tissue disorders

20%

Injury, poisoning and procedural complications

18%

Reproductive system and breast disorder

15%

Breast Pain

14%

Fibrosis deep connective tissue

14%

Dermatitis radiation

10%

Superficial soft tissue fibrosis

Seroma

Skin and subcutaneous tissue disorders

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (APBI Using HDR Brachytherapy)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (high dose rate brachytherapy, hyperthermia)Experimental Treatment3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

High-Dose Rate Brachytherapy

2004

Completed Phase 2

~530

Hyperthermia Treatment

2013

N/A

~10