SBRT for Prostate Cancer

Overseen By Comron Hassanzadeh, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must be taking: Androgen deprivation therapy

Disqualifiers: Scleroderma, Lupus, Prior prostatectomy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

70 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on androgen deprivation therapy (ADT), you may continue as long as it started within 185 days before registration.

What data supports the effectiveness of the treatment Stereotactic Body Radiation Therapy, Stereotactic Ablative Radiotherapy (SABR), CyberKnife for prostate cancer?

Research shows that Stereotactic Ablative Radiotherapy (SABR) using the CyberKnife system is promising for treating prostate cancer, with studies indicating it is effective for both low-risk and intermediate- to very-high-risk cases. ^{1 2 3 4 5}

Is stereotactic body radiation therapy (SBRT) safe for treating prostate cancer?

Studies show that stereotactic body radiation therapy (SBRT), including the use of CyberKnife, is generally safe for treating prostate cancer, with research focusing on its safety and feasibility for various risk levels of the disease. ^{1 3 6 7 8}

How is the treatment SBRT for prostate cancer different from other treatments?

SBRT (Stereotactic Body Radiation Therapy) for prostate cancer is unique because it uses precise, high-dose radiation delivered in fewer sessions, often with the help of a robotic system like CyberKnife, which allows for targeted treatment with minimal damage to surrounding healthy tissue. ^{1 3 4 9 10}

What is the purpose of this trial?

To look at the safety and effectiveness of stereotactic body radiation therapy (SBRT) in treating advanced or high-risk prostate cancer.

Research Team

Comron Hassanzadeh, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for men over 18 with advanced or high-risk prostate cancer that hasn't spread to other parts of the body. They should have a certain level of physical fitness (ECOG 0-2) and a specific grade of tumor severity (Gleason Grade Group 2-5). Prior hormone treatment for prostate cancer is okay if it started less than about six months ago.

Inclusion Criteria

My cancer is at a stage that can be treated but has not spread extensively.

I can take care of myself and perform daily activities.

My prostate cancer was confirmed by a lab test within the last year.

Exclusion Criteria

My cancer has spread and cannot be completely treated.

I've had radiation in the same area as my current cancer.

I have had surgery or cryosurgery for prostate cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive stereotactic body radiation therapy (SBRT) over 5 sessions, 2-3 times per week, for 2 weeks

2 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3, 6, 12, and 24 months post-treatment

24 months

Treatment Details

Interventions

• Stereotactic Body Radiation Therapy

Trial Overview The PRORAD-5 study tests how safe and effective Stereotactic Body Radiation Therapy (SBRT) is in treating advanced prostate cancer. SBRT delivers precise, high-dose radiation to the tumor in fewer sessions compared to traditional therapy.

Participant Groups

Group I: Stereotactic Body Radiation Therapy Experimental Treatment 1 Intervention

Participants will then be scheduled to receive radiation therapy. Radiation will be given over 5 sessions, 2-3 times per week, for 2 weeks. Each radiation therapy session will take 15-30 minutes to complete. Within 1 day after completing radiation therapy, blood (about 2 tablespoons) will be drawn for routine tests.

Stereotactic Body Radiation Therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Stereotactic Body Radiation Therapy for:

• Non-small cell lung cancer (NSCLC)
• Melanoma
• Renal cell carcinoma (RCC)
• Prostate cancer
• Oligoprogressive cancers

Approved in European Union as Stereotactic Body Radiation Therapy for:

• Non-small cell lung cancer (NSCLC)
• Melanoma
• Renal cell carcinoma (RCC)
• Prostate cancer
• Oligoprogressive cancers

Approved in Canada as Stereotactic Body Radiation Therapy for:

• Non-small cell lung cancer (NSCLC)
• Melanoma
• Renal cell carcinoma (RCC)
• Prostate cancer
• Oligoprogressive cancers

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Findings from Research

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]

In a study of 84 low-risk prostate cancer patients treated with Stereotactic Ablative Body Radiotherapy (SABR), long-term quality of life (QOL) outcomes were generally positive, with a median follow-up of 50.8 months, although some patients reported declines in urinary (17.9%), bowel (26.2%), and sexual (37.5%) QOL domains.

Dosimetric factors such as rectal D1cc and penile bulb V35 were identified as significant predictors of worse QOL, highlighting the importance of adhering to strict dosimetric constraints to minimize side effects from treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric and patient correlates of quality of life after prostate stereotactic ablative radiotherapy. Elias, E., Helou, J., Zhang, L., et al.[2018]

In a study of 29 prostate cancer patients treated with stereotactic body radiotherapy (SBRT) using a Cyberknife, PSA levels showed a significant decrease over time, with a median nadir of 0.329 ng/mL achieved after 23 months.

The treatment demonstrated a favorable safety profile, with only 3% of patients experiencing Grade 2 urinary toxicities and no severe late rectal toxicities reported, indicating that SBRT is a feasible option for prostate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for prostate cancer: a preliminary report. Lee, YH., Son, SH., Yoon, SC., et al.[2022]

In a study of 33 patients with low- and intermediate-risk prostate cancer treated with CyberKnife SBRT, there was no biochemical failure, indicating high efficacy of the treatment over a median follow-up of 51 months.

The treatment resulted in manageable side effects, with no grade 3 acute or late toxicities reported, and most acute complications resolved within 2 months, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated stereotactic body radiotherapy in low- and intermediate-risk prostate carcinoma. Kim, HJ., Phak, JH., Kim, WC.[2022]

In a study comparing three radiotherapy techniques for prostate cancer treatment, RapidArc (RA) demonstrated superior target dose distribution and better sparing of critical structures compared to Cyberknife (CK) and Helical Tomotherapy (HT).

RA also had a better conformity index and gradient index, while CK required significantly more monitor units and beam-on time, indicating it may be less efficient than RA for delivering the same treatment margins.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cyberknife, Helical Tomotherapy and Rapid Arc SIB-SBRT Treatment Plan Comparison for Carcinoma Prostate. T K, B., K M, G., A, P., et al.[2021]

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]

In a study of 230 men with early low-risk prostate cancer treated with stereotactic body radiotherapy (SBRT), the ten-year biochemical disease-free survival rate was an impressive 93%, indicating high efficacy of this treatment.

The treatment showed low toxicity, with only 10% of patients experiencing mild late urinary toxicity and 4% with late rectal toxicity, while quality of life scores for bowel and urinary function returned to baseline after initial declines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiotherapy for Low-Risk Prostate Cancer: A Ten-Year Analysis. Katz, A.[2020]

Stereotactic ablative radiotherapy (SABR) using Cyberknife demonstrated high effectiveness in treating stage I non-small-cell lung cancer, with 2-year local control, progression-free, and overall survival rates of 91.9%, 61.7%, and 84.8%, respectively, based on a study of 153 patients.

The treatment was generally safe, with only 8.1% of patients experiencing severe toxicities, including one case of grade 5 radiation pneumonitis, indicating that while SABR is effective, careful monitoring for side effects is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Radiotherapy Using CyberKnife for Stage I Non-small-cell Lung Cancer: A Retrospective Analysis. Hayashi, K., Suzuki, O., Shiomi, H., et al.[2022]

The Cyberknife® system, used for stereotactic body radiation therapy (SBRT), shows promising efficacy in treating localized prostate cancer, with median PSA levels dropping significantly after treatment and biochemical progression-free survival rates ranging from 78.3% to 100% over a follow-up period of 4 to 60 months.

While the treatment is associated with mostly mild side effects (grade 1/2), there are reports of erectile dysfunction and some grade 3 toxicities, indicating a need for further long-term studies and randomized trials to establish its safety and effectiveness as a standard treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current role of image-guided robotic radiosurgery (Cyberknife(®) ) for prostate cancer treatment. Seisen, T., Drouin, SJ., Phé, V., et al.[2018]

A single session of stereotactic ablative body radiotherapy (SABR) for oligometastatic prostate cancer was found to be feasible and safe, with only one significant adverse event (a vertebral fracture) reported among 33 patients over a 2-year follow-up period.

The treatment resulted in high local progression-free survival rates of 97% at 1 year and 93% at 2 years, with nearly half of the patients (48%) avoiding the need for androgen deprivation therapy at the 2-year mark, indicating effective disease control and maintained quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Abative Body Radiotherapy (SABR) for Oligometastatic Prostate Cancer: A Prospective Clinical Trial. Siva, S., Bressel, M., Murphy, DG., et al.[2022]

References

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

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

2. Ireland pubmed.ncbi.nlm.nih.gov

Dosimetric and patient correlates of quality of life after prostate stereotactic ablative radiotherapy. [2018]

3. Australia pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for prostate cancer: a preliminary report. [2022]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Hypofractionated stereotactic body radiotherapy in low- and intermediate-risk prostate carcinoma. [2022]

5. Thailand pubmed.ncbi.nlm.nih.gov

Cyberknife, Helical Tomotherapy and Rapid Arc SIB-SBRT Treatment Plan Comparison for Carcinoma Prostate. [2021]

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

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

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

Stereotactic Body Radiotherapy for Low-Risk Prostate Cancer: A Ten-Year Analysis. [2020]

8. Greece pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Radiotherapy Using CyberKnife for Stage I Non-small-cell Lung Cancer: A Retrospective Analysis. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Current role of image-guided robotic radiosurgery (Cyberknife(®) ) for prostate cancer treatment. [2018]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Stereotactic Abative Body Radiotherapy (SABR) for Oligometastatic Prostate Cancer: A Prospective Clinical Trial. [2022]