Hyperthermia + Radiation for Recurrent Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Disqualifiers: Urological surgery, Metastatic disease, Mental incompetence, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

3 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, prior androgen deprivation or chemotherapy must be stopped at least 30 days before joining the trial.

What data supports the effectiveness of this treatment for recurrent prostate cancer?

Research suggests that combining hyperthermia (heating the body tissue) with high-dose-rate brachytherapy (a type of internal radiation therapy) can be a promising option for treating recurrent prostate cancer. Studies indicate that this combination may enhance the effectiveness of radiation therapy by improving tumor control and potentially reducing the cancer's ability to repair itself. ^{1 2 3 4 5}

Is the combination of hyperthermia and HDR brachytherapy safe for treating prostate cancer?

Studies have shown that combining hyperthermia (heating the prostate) with HDR brachytherapy (a type of internal radiation) is generally safe for treating prostate cancer, with acceptable levels of side effects related to the urinary and digestive systems. ^{1 2 3 5 6}

How is the treatment of hyperthermia combined with HDR brachytherapy unique for recurrent prostate cancer?

This treatment is unique because it combines high-dose rate brachytherapy (a type of internal radiation therapy) with interstitial hyperthermia (heating the prostate tissue) to enhance the effectiveness of re-irradiation for prostate cancer that has returned after previous radiation therapy. This approach is still being studied to determine the best dosage and schedule, as there is no standard treatment for this specific condition. ^{1 2 3 7 8}

Research Team

Jessie DiNome, MD

Principal Investigator

Thomas Jefferson University

Eligibility Criteria

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.

Inclusion Criteria

You are expected to live for at least 3 more years.

I stopped hormone therapy or chemotherapy more than 30 days ago.

My other health conditions won't affect or increase risks for my treatment, according to my doctor.

Exclusion Criteria

My cancer has spread to distant parts of my body.

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)

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo high dose rate brachytherapy followed immediately by interstitial hyperthermia treatment

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

1 week, 1 month, every 3 months for 2 years, every 6 months for 3 years, annually thereafter

Treatment Details

Interventions

• High-Dose Rate Brachytherapy
• Hyperthermia Treatment

Trial Overview 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.

Participant Groups

Group I: Treatment (high dose rate brachytherapy, hyperthermia) Experimental Treatment 3 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.

High-Dose Rate Brachytherapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as High-Dose Rate Brachytherapy for:

• Prostate adenocarcinoma
• Cervical cancer
• Breast cancer
• Skin cancer

Approved in European Union as High-Dose Rate Brachytherapy for:

• Prostate adenocarcinoma
• Cervical cancer
• Breast cancer
• Skin cancer
• Esophageal cancer

Approved in Canada as High-Dose Rate Brachytherapy for:

• Prostate adenocarcinoma
• Cervical cancer
• Breast cancer

Who Is Running the Clinical Trial?

Sidney Kimmel Cancer Center at Thomas Jefferson University

Lead Sponsor

Trials

164

Recruited

10,900+

Findings from Research

In a study of 101 patients with localized prostate cancer, high-dose rate brachytherapy (HDR) combined with external beam radiation (EBRT) showed promising early efficacy, with 82% of patients free from cancer recurrence after a median follow-up of 56 months.

While there were some significant acute toxicities, such as clot retention and a few serious complications, the long-term side effects were relatively low, with only 8% experiencing late grade 2 genitourinary toxicity and no late grade 3 gastrointestinal toxicity observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HDR brachytherapy combined with external beam radiation for localised prostate cancer: early experience from the Sydney Cancer Centre. Whalley, D., Patanjali, N., Jackson, M., et al.[2018]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Salvage prostate HDR brachytherapy combined with interstitial hyperthermia for local recurrence after radiation therapy failure. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Interstitial hyperthermia of the prostate in combination with brachytherapy : An evaluation of feasibility and early tolerance. [2021]

3. Poland pubmed.ncbi.nlm.nih.gov

Salvage brachytherapy in combination with interstitial hyperthermia for locally recurrent prostate carcinoma following external beam radiation therapy: a prospective phase II study. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Combined hyperthermia and radiotherapy for prostate cancer: a systematic review. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Does microwave interstitial hyperthermia prior to high-dose-rate brachytherapy change prostate volume or therapy plan parameters? [2015]

6. Australia pubmed.ncbi.nlm.nih.gov

HDR brachytherapy combined with external beam radiation for localised prostate cancer: early experience from the Sydney Cancer Centre. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Combined external beam irradiation and external regional hyperthermia for locally advanced adenocarcinoma of the prostate. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

Reirradiation for recurrent head and neck cancer with salvage interstitial pulsed-dose-rate brachytherapy: Long-term results. [2022]