Combined Radiation Therapy for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Disqualifiers: Urological surgery, Pelvic irradiation, Metastatic disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to treating prostate cancer using two types of radiation therapy. First, high dose rate brachytherapy (internal radiation therapy) places radiation directly inside the body for a short time. Then, stereotactic body radiation therapy (SBRT) delivers focused radiation to the tumor over three weeks. The trial aims to determine the safety of combining these methods. Men with intermediate-risk prostate cancer, without signs of spreading, are likely suitable candidates. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this combined radiation therapy is safe for prostate cancer?

Research has shown that both high-dose rate (HDR) brachytherapy and stereotactic body radiation therapy (SBRT) are promising and safe options for treating prostate cancer.

For HDR brachytherapy, studies indicate it is generally well-tolerated. Many patients have experienced good cancer control with few side effects over the years, making it a safe choice for prostate cancer treatment.

SBRT has also proven to be safe and effective. Only a small number of patients experience significant side effects. Research shows it can precisely target cancer cells, which helps protect healthy tissues.

While this trial is in its early phase, meaning safety is still being closely monitored, these treatments have a strong safety record in previous studies. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combined use of High-Dose Rate (HDR) brachytherapy and Stereotactic Body Radiation Therapy (SBRT) for prostate cancer because it offers a potentially more precise and targeted approach compared to traditional radiation therapies. Unlike conventional treatments that may require longer durations and potentially affect surrounding healthy tissues, HDR brachytherapy delivers a high dose of radiation directly to the prostate in a single session, while SBRT follows with highly focused radiation over a short period. This combination aims to maximize the cancer-killing effect while minimizing side effects, potentially leading to quicker recovery times and improved quality of life for patients.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

Research has shown that high-dose rate (HDR) brachytherapy effectively controls prostate cancer. Studies indicate high success rates, especially for men whose cancer remains confined to the prostate. HDR brachytherapy has kept cancer under control even 8 years after treatment.

Stereotactic body radiation therapy (SBRT) also effectively treats prostate cancer, offering excellent long-term control, particularly for men with low- and intermediate-risk cancer. In this trial, participants will receive a combination of HDR brachytherapy followed by SBRT, potentially providing a strong and precise treatment option for prostate cancer. ^{1 3 4 6 7}

Who Is on the Research Team?

Robert B. Den

Principal Investigator

Thomas Jefferson University

Are You a Good Fit for This Trial?

Men over 18 with intermediate-risk prostate cancer (specific criteria like T2b-T2c, Gleason score of 7, or PSA levels of 10-20 ng/ml) without metastatic disease can join. They must have certain blood cell counts, agree to use contraception for three months post-treatment, and not have had previous pelvic radiation or surgeries that could complicate treatment.

Inclusion Criteria

I've had a bone scan and CT scan of my abdomen/pelvis in the last 60 days.

My prostate cancer is at an intermediate stage, without spread to other parts.

I am able to care for myself and perform normal activities with minimal assistance.

Exclusion Criteria

I have had surgery on my urinary system that might complicate radiation treatment.

My cancer has spread to distant parts of my body.

I have had surgery or cryosurgery 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 HDR brachytherapy on day 0 followed by SBRT on days 15-30

3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• High-Dose Rate Brachytherapy
• Stereotactic Body Radiation Therapy

Trial Overview The trial is testing the safety of combining two types of radiation therapy: high-dose rate brachytherapy (internal radiation) and stereotactic body radiation therapy (SBRT), which delivers precise doses in a short period. The goal is to see if this combination effectively treats prostate cancer.

How Is the Trial Designed?

Group I: Treatment (HDR brachytherapy, SBRT) Experimental Treatment 4 Interventions

Patients undergo HDR brachytherapy on day 0 followed by SBRT on days 15-30

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 involving 32 patients with early-stage prostate cancer treated with Cyberknife, 29 patients remained free of disease at the last follow-up, indicating strong efficacy of this treatment.

While some patients experienced mild to moderate side effects, including acute genitourinary toxicity and proctitis, all patients were alive at the last follow-up, suggesting that Cyberknife is a safe option for localized prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cyberknife treatment for low and intermediate risk prostate cancer. Detti, B., Bonomo, P., Masi, L., et al.[2015]

CyberKnife (CK) stereotactic body radiotherapy (SBRT) can effectively replicate the dose and distribution of high-dose-rate (HDR) brachytherapy for prostate cancer, with similar planning target volume coverage and improved urethra dose sparing in 9 out of 10 patients.

Early clinical results show a significant reduction in prostate-specific antigen levels (86% decrease from baseline) after CK SBRT, with minimal and transient acute toxicity, primarily urologic, indicating a promising safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual HDR CyberKnife treatment for localized prostatic carcinoma: dosimetry comparison with HDR brachytherapy and preliminary clinical observations. Fuller, DB., Naitoh, J., Lee, C., et al.[2022]

In a study of 101 patients with higher-risk localized prostate cancer, combining high-dose-rate (HDR) brachytherapy with stereotactic body radiation therapy (SBRT) resulted in a very low incidence of severe toxicities, with no grade ≥3 toxicities observed and only 0.99% experiencing grade 2 gastrointestinal issues.

The treatment showed promising efficacy, with a 2-year biochemical relapse-free survival rate of 97%, indicating strong cancer control outcomes alongside a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early outcomes of high-dose-rate brachytherapy combined with ultra-hypofractionated radiation in higher-risk prostate cancer. Gorovets, D., Hopkins, M., Kollmeier, M., et al.[2021]

In a study comparing two-fraction stereotactic ablative radiotherapy (SABR) and two-fraction high dose rate (HDR) brachytherapy for localized prostate cancer, both treatments showed similar rates of biochemical failure after 72 months, with SABR having a slightly lower failure rate of 3.5% compared to 12.8% for HDR.

Both SABR and HDR treatments exhibited low rates of significant toxicity and maintained comparable quality of life scores, suggesting that SABR is a safe and effective alternative to HDR brachytherapy for prostate cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-fraction stereotactic ablative radiotherapy (SABR) versus two-fraction high dose rate (HDR) brachytherapy for localized prostate cancer: Does dose heterogeneity matter? Correa, RJM., Morton, G., Chung, HT., et al.[2022]

The CyberKnife robotic system for prostate cancer treatment shows promise as a comparable option to high dose rate brachytherapy, suggesting it could be a viable alternative in radiation therapy.

While the CyberKnife may be seen as a technical improvement over existing treatments, further clinical and economic evaluations are necessary to fully understand its effectiveness and potential benefits in prostate cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Robotic radiotherapy for prostate cancer with CyberKnife]. Hannoun-Levi, JM., Benezery, K., Bondiau, PY., et al.[2022]

Stereotactic ablative radiation (SAbR) at a dose of 45 Gy in 5 fractions shows a promising safety profile for treating localized prostate cancer, with acute urinary and gastrointestinal toxicity rates of 20.4% and 7.3%, respectively, and low rates of late toxicity after 2 years.

The treatment demonstrated excellent efficacy, with a biochemical failure-free survival rate of 100% at 1 year and 98.7% at 2 years, indicating strong disease control outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-Intensified Stereotactic Ablative Radiation for Localized Prostate Cancer. Chen, L., Gannavarapu, BS., Desai, NB., et al.[2022]

High-dose-rate brachytherapy (HDR BRT) is gaining popularity as a treatment for prostate cancer, showing promise in both monotherapy and in combination with external beam radiation therapy (EBRT).

Long-term data indicates that HDR BRT provides effective oncologic outcomes while maintaining a manageable toxicity profile, supporting its use in various clinical scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-dose-rate brachytherapy for prostate cancer: Rationale, current applications, and clinical outcome. Strouthos, I., Karagiannis, E., Zamboglou, N., et al.[2022]

Stereotactic body radiation therapy (SBRT) using CyberKnife for localized prostate cancer was found to be safe, with no severe treatment-related toxicities (grade 3 or higher) reported among 44 patients over a median follow-up of 40 months.

The treatment showed excellent efficacy, with a 100% cause-specific survival rate and progression-free survival rate, and a high biochemical failure-free rate of 90.8% for high-risk patients, particularly with the 34 Gy in 4 fractions regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image-guided stereotactic body radiation therapy for localized prostate cancer. Kang, JK., Cho, CK., Choi, CW., et al.[2022]

Combination high dose rate brachytherapy (HDRB) with external beam radiation therapy is a feasible and effective treatment for localized prostate cancer, showing a 91% prostate-specific antigen progression-free survival rate in 82 patients over a median follow-up of 3 years.

The use of HDRB allows for a shorter overall treatment time and is advantageous both biologically and logistically, making it a practical option for facilities that can perform brachytherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of localized prostate cancer using a combination of high dose rate Iridium-192 brachytherapy and external beam irradiation: initial Australian experience. Stevens, MJ., Stricker, PD., Saalfeld, J., et al.[2019]

CyberKnife stereotactic ablative radiotherapy (SABR) for treating intermediate- to very-high-risk prostate cancer showed a high 3-year biochemical relapse-free survival rate of 90.2%, indicating its efficacy in managing this condition.

The treatment was well-tolerated, with no patients experiencing severe toxicity (≥ grade 3), and only mild genitourinary and gastrointestinal side effects were reported, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy with CyberKnife in the treatment of locally advanced prostate cancer: preliminary results. Fan, CY., Chao, HL., Huang, WY., et al.[2017]

Citations

1. 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 ...

2. 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 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2452109425001484

High-dose-rate brachytherapy boost for prostate cancer: A ... Overall, this study demonstrated the efficacy of EBRT-boosted brachytherapy in the treatment of intermediate- and high-risk prostate cancer, ...

4. 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- ...

5. urotoday.com urotoday.com/conference-highlights/astro-2024/astro-2024-prostate-cancer/155302-astro-2024-a-randomized-comparison-of-low-dose-rate-or-high-dose-rate-brachytherapy-combined-with-external-beam-radiation-for-unfavorable-intermediate-or-high-risk-prostate-cancer-efficacy-results-at-median-6-years.html

ASTRO 2024: A Randomized Comparison of Low Dose ... HDR and LDR boost both appear to be highly effective for the treatment of unfavorable risk prostate cancer, with 85% biochemical cure (i.e., PSA ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38160102/

Safety of high-dose rate (HDR) brachytherapy for patients ... Conclusions: HDR-BT is a safe treatment for patients with prostate cancer who previously received RT for rectal cancer. Further studies are ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2405630825000138

Effectiveness, toxicity and impact on quality of life of high ... High-dose-rate brachytherapy is an option for prostate cancer patients. •. Two fractions of high-dose-rate brachytherapy as monotherpy appear to be safe. •.