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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of heat therapy and radiation to determine its effectiveness in treating prostate cancer that has returned after earlier radiation treatment. High-Dose Rate Brachytherapy, or Internal Radiation Therapy, delivers a high dose directly near the tumor, while the heat therapy aims to increase the cancer cells' sensitivity to this radiation. Men whose prostate cancer has returned after previous radiation treatments, without signs of spreading to other parts of the body, may be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for recurrent prostate cancer.

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 prior data suggests that hyperthermia and high-dose rate brachytherapy are safe for treating recurrent prostate cancer?

Research has shown that high-dose rate brachytherapy, a type of radiation treatment where radioactive material is placed close to a tumor, is generally safe. Studies indicate it is well-tolerated and effective for treating prostate cancer, even if the cancer returns. Patients have experienced good control over their cancer, and the side effects remain manageable.

For hyperthermia therapy, which involves heating tumor cells to make them more sensitive to radiation, research also shows it is safe. It is often used with radiation for better results, and most patients handle it well.

Both treatments have proven successful, and side effects are usually mild. This suggests that combining these therapies is likely safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for recurrent prostate cancer, which often involve hormone therapy and external beam radiation, this new approach combines high-dose rate brachytherapy with interstitial hyperthermia. Researchers are excited about this treatment because hyperthermia, or the use of heat, enhances the cancer-killing effects of radiation, potentially improving outcomes. This innovative combination could lead to more effective and faster results by precisely targeting cancer cells and minimizing damage to surrounding healthy tissue.

What evidence suggests that hyperthermia and high-dose rate brachytherapy could be effective for recurrent prostate cancer?

This trial will evaluate the combination of high-dose rate brachytherapy and hyperthermia treatment for recurrent prostate cancer. Studies have shown that high-dose rate brachytherapy, which places radioactive material close to the tumor, can effectively control prostate cancer and is safe for patients with recurrent cancer. Specifically, one study demonstrated strong disease control rates for men with localized prostate cancer using this method. For hyperthermia treatment, which heats tumor cells to increase their sensitivity to radiation, research indicates it can be safely combined with radiation to improve outcomes in recurrent cases. Combining hyperthermia with radiation therapy has improved disease-free survival rates by 20% compared to radiation alone. This combination treatment might be more effective for patients whose cancer has returned after previous radiation treatment. ^{1 2 3 4 5}

Who Is on the Research Team?

Jessie DiNome, MD

Principal Investigator

Thomas Jefferson University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12190164/

Long-Term Outcomes After High-Dose-Rate Brachytherapy ... These outcomes included lower biochemical recurrence-free survival at 5 and 8 years, lower OS, and lower prostate CSS compared to patients with ...

2. advancesradonc.org advancesradonc.org/article/S2452-1094(25)00148-4/fulltext

High-Dose-Rate Brachytherapy Boost for Prostate Cancer However, studies have shown that combining brachytherapy with EBRT results in a higher rate of cancer control than EBRT alone. Nevertheless, the ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6043748/

High dose-rate brachytherapy in the treatment of prostate cancer In summary, HDR brachytherapy boost results in a high disease control rates for men with localized prostate cancer, with strong evidence that it provides ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0167814025046493

High-Dose-Rate brachytherapy for salvage treatment of ... HDR-BT is a safe and effective salvage option for well-selected patients with local recurrence after RP and a/sEBRT. Our data support its ...

5. thegreenjournal.com thegreenjournal.com/article/S0167-8140(24)00651-0/fulltext

Prostate high dose-rate brachytherapy as monotherapy for ... HDR monotherapy delivered in two fractions of 13.5 Gy demonstrated a persistent cancer control rate at 8 years and was well-tolerated. Single- ...