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

42 Participants Needed

Trial Summary

What is the purpose of this trial?

The first technology is called high dose rate brachytherapy. Brachytherapy is sometimes called internal radiation therapy. High dose rate brachytherapy is a procedure that involves temporarily placing radioactive material inside the patient's body for about 10-20 minutes. Then, the remainder of the radiation treatment will be given over a 3 week period using stereotactic body radiation therapy (SBRT). SBRT is a novel treatment modality that involves the delivery of very high individual doses of radiation to tumors with high precision. This allows the doctor to deliver the same amount of radiation in a much shorter time. The purpose of this study is to determine the safety of brachytherapy when combined with hypofractionated SBRT.

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 data supports the effectiveness of the treatment Combined Radiation Therapy for Prostate Cancer?

Research shows that using CyberKnife, a type of precise radiation therapy, can effectively target prostate cancer similarly to high-dose-rate brachytherapy, which is already a validated treatment. Studies also suggest that combining high-dose-rate brachytherapy with stereotactic body radiation therapy (SBRT) can be effective for higher-risk prostate cancer. ^{1 2 3 4 5}

Is combined radiation therapy for prostate cancer safe?

Studies show that treatments like CyberKnife and stereotactic body radiation therapy (SBRT) are generally safe for prostate cancer, with some patients experiencing mild to moderate side effects like urinary issues and inflammation of the rectum. Most patients in these studies remained free of disease and were alive at follow-up. ^{2 3 6 7 8}

How is the combined radiation therapy for prostate cancer different from other treatments?

This treatment combines high-dose rate brachytherapy (internal radiation) with stereotactic body radiation therapy (CyberKnife), offering precise targeting and dose escalation, which can shorten treatment time and potentially reduce side effects compared to traditional radiation therapies. ^{1 3 4 9 10}

Research Team

Robert B. Den

Principal Investigator

Thomas Jefferson University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

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]

References

1. France pubmed.ncbi.nlm.nih.gov

[Robotic radiotherapy for prostate cancer with CyberKnife]. [2022]

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

Stereotactic ablative radiotherapy with CyberKnife in the treatment of locally advanced prostate cancer: preliminary results. [2017]

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

Virtual HDR CyberKnife treatment for localized prostatic carcinoma: dosimetry comparison with HDR brachytherapy and preliminary clinical observations. [2022]

4. Ireland 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? [2022]

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

Early outcomes of high-dose-rate brachytherapy combined with ultra-hypofractionated radiation in higher-risk prostate cancer. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Dose-Intensified Stereotactic Ablative Radiation for Localized Prostate Cancer. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Cyberknife treatment for low and intermediate risk prostate cancer. [2015]

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

Image-guided stereotactic body radiation therapy for localized prostate cancer. [2022]

9. Australia 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. [2019]

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

High-dose-rate brachytherapy for prostate cancer: Rationale, current applications, and clinical outcome. [2022]