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Brachytherapy

Hyperthermia + Radiation for Recurrent Prostate Cancer

Q: Is there still an opportunity to participate in this research endeavor?

<p>The information hosted on clinicaltrials.gov suggests that this particular medical trial is no longer actively recruiting patients, as the study has not been modified since July 19th 2021. Nevertheless, there are 2360 other studies currently open for recruitment at this moment in time.</p>

Q: Has the FDA signified acceptance of High-Dose Rate Brachytherapy?

<p>Considering the limited existing evidence supporting High-Dose Rate Brachytherapy's efficacy and safety, our team at Power gave it a score of 1.</p>

N/A

Waitlist Available

Led By Adam Mueller, 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%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

Select...

I am mostly independent and can care for myself.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

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

Secondary outcome measures

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)

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%

Dermatitis radiation

14%

Fibrosis deep connective tissue

10%

Superficial soft tissue fibrosis

Seroma

Skin and subcutaneous tissue disorders

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (APBI Using HDR Brachytherapy)

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sidney Kimmel Cancer Center at Thomas Jefferson UniversityLead Sponsor

162 Previous Clinical Trials

10,908 Total Patients Enrolled

13 Trials studying Prostate Cancer

1,567 Patients Enrolled for Prostate Cancer

Adam Mueller, MDPrincipal InvestigatorThomas Jefferson University

2 Previous Clinical Trials

88 Total Patients Enrolled

Media Library

High-Dose Rate Brachytherapy (Brachytherapy) Clinical Trial Eligibility Overview. Trial Name: NCT02899221 — N/A

Prostate Cancer Research Study Groups: Treatment (high dose rate brachytherapy, hyperthermia)

Prostate Cancer Clinical Trial 2023: High-Dose Rate Brachytherapy Highlights & Side Effects. Trial Name: NCT02899221 — N/A

High-Dose Rate Brachytherapy (Brachytherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02899221 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still an opportunity to participate in this research endeavor?

"The information hosted on clinicaltrials.gov suggests that this particular medical trial is no longer actively recruiting patients, as the study has not been modified since July 19th 2021. Nevertheless, there are 2360 other studies currently open for recruitment at this moment in time."

Answered by AI