SBRT Boost for Prostate Cancer

Overseen By Annie Jose, BS

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Boston Medical Center

Must be taking: Androgen deprivation

Disqualifiers: Prostate surgery, Radiotherapy, Chemotherapy, Invasive malignancy, others

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

Compensation: Varies

Number of Visits: 3

35 Participants Needed

Trial Summary

What is the purpose of this trial?

In this study, participants will have standard Androgen Deprivation Therapy and undergo standard external beam radiation therapy to the prostate and at-risk lymph nodes by Intensity Modulated Radiation Therapy. The subsequent \*boost\* radiation therapy to the prostate alone will be given using the CyberKnife, rather than using the standard Intensity Modulated Radiation Therapy. This study will also see how CyberKnife affects the quality of the participant's life.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you must be receiving or planning to receive standard androgen deprivation therapy as part of the trial.

What data supports the effectiveness of the treatment CyberKnife Boost for prostate cancer?

Research shows that using CyberKnife for stereotactic body radiotherapy (SBRT) in prostate cancer is effective, especially when combined with whole pelvis radiotherapy. Studies have reported positive outcomes for patients with intermediate- to high-risk prostate cancer, indicating that this treatment can be beneficial. ^{1 2 3 4 5}

Is SBRT Boost (CyberKnife Boost) safe for treating prostate cancer?

Research shows that SBRT using CyberKnife is generally safe for prostate cancer patients, with no severe acute complications reported and only a small percentage experiencing significant late urinary issues. Studies indicate favorable safety outcomes even in older patients or those with other health conditions. ^{1 5 6 7 8}

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

The SBRT Boost treatment for prostate cancer is unique because it uses a method called stereotactic body radiotherapy (SBRT) to deliver high doses of radiation in fewer sessions, which can be more convenient and potentially more effective for certain patients. This approach is different from traditional radiation therapy, which typically involves more sessions with lower doses. ^{1 2 4 5 9}

Research Team

Ariel E. Hirsch

Principal Investigator

Boston Medical Center

Eligibility Criteria

This trial is for men over 18 with prostate cancer, a Gleason score of 2-10, and no prior pelvic radiotherapy or prostate surgery. They must be able to have an MRI, not have inflammatory bowel disease or certain other health conditions, and agree to complete questionnaires.

Inclusion Criteria

My prostate cancer is classified as high risk based on PSA levels, Gleason score, or tumor stage.

I am undergoing or planning to start hormone therapy and radiation for prostate cancer.

My prostate is larger than 20cc but smaller than 100cc.

Exclusion Criteria

I haven't had chemotherapy for cancer in the last 5 years.

No implanted hardware (including metal) or other material that would prohibit appropriate treatment planning or treatment delivery

I haven't had any cancer except for skin cancer in the last 5 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Androgen Deprivation Therapy

Participants receive standard androgen deprivation therapy

Varies

External Beam Radiation Therapy

Participants undergo standard external beam radiation therapy to the prostate and at-risk lymph nodes by Intensity Modulated Radiation Therapy

Varies

CyberKnife Boost Radiation Therapy

Participants receive boost radiation therapy to the prostate using CyberKnife

1 week

3 sessions, every other day

Follow-up

Participants are monitored for safety and effectiveness after treatment, including quality of life assessments

5 years

Treatment Details

Interventions

• CyberKnife Boost

Trial Overview The study tests if using CyberKnife for boost radiation therapy after standard treatments improves outcomes in prostate cancer patients. It compares this method against the usual Intensity Modulated Radiation Therapy boost while monitoring quality of life impacts.

Participant Groups

Group I: Boost Experimental Treatment 1 Intervention

CyberKnife Boost 21 Gy in 7 Gy per day, 3 fractions, Every other day

Who Is Running the Clinical Trial?

Boston Medical Center

Lead Sponsor

Trials

410

Recruited

890,000+

Findings from Research

In a study of 39 patients with intermediate- to high-risk prostate cancer, the combination of whole pelvis radiotherapy (WPRT) and a Cyberknife SBRT boost resulted in a high 5-year biochemical failure-free survival rate of 94.7%.

The treatment was associated with minimal toxicity, with no grade 3 acute side effects reported, although 23% experienced grade 2 acute genitourinary and 21% had grade 2 acute gastrointestinal toxicities, which mostly resolved within 2 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of whole pelvis radiotherapy and stereotactic body radiotherapy boost for intermediate- and high-risk prostate cancer. Kim, HJ., Phak, JH., Kim, WC.[2018]

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 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 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]

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 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]

In a study of 45 prostate cancer patients treated with stereotactic body radiation therapy (SBRT) using Cyberknife, the 5-year biochemical relapse-free survival (bRFS) rate was high at 89.7%, indicating effective long-term control of the disease.

The treatment was found to be safe, with no severe acute complications and only 4.4% of patients experiencing grade 3 or higher late urinary toxicity, suggesting that SBRT is a viable option for older patients or those with medical comorbidities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy for prostate cancer patients with old age or medical comorbidity: a 5-year follow-up of an investigational study. Lee, SW., Jang, HS., Lee, JH., et al.[2022]

In a study involving 24 patients with intermediate- to high-risk prostate cancer, hypofractionated stereotactic body radiation therapy (SBRT) using the CyberKnife system showed promising results, with a significant decrease in median PSA levels from 10.6 ng/ml to 1.5 ng/ml within 6 months post-treatment.

The treatment was well tolerated, with only mild acute urinary and gastrointestinal toxicities reported, and no severe Grade 3 or greater toxicities, indicating a favorable safety profile for this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of intensity modulated radiation therapy with hypofractionated stereotactic body radiation therapy (SBRT) boost in the treatment of intermediate- to high-risk prostate cancer. Oermann, EK., Slack, RS., Hanscom, HN., et al.[2022]

In a phase 1 trial involving 30 patients with intermediate-risk prostate cancer, single-fraction stereotactic body radiation therapy (SBRT) boost was found to be feasible and well tolerated, with a median follow-up of 72 months.

Higher doses of SBRT (up to 15 Gy) resulted in lower prostate-specific antigen (PSA) levels, indicating better treatment efficacy, although there were some cases of significant toxicity, including a grade 4 rectal fistula linked to repeated biopsies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiation Therapy Boost for Intermediate-Risk Prostate Cancer: A Phase 1 Dose-Escalation Study. Alayed, Y., Loblaw, A., Chu, W., et al.[2021]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Clinical outcomes of whole pelvis radiotherapy and stereotactic body radiotherapy boost for intermediate- and high-risk prostate cancer. [2018]

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

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

3. 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]

4. Thailand pubmed.ncbi.nlm.nih.gov

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

5. Australia pubmed.ncbi.nlm.nih.gov

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

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

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

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

Stereotactic body radiation therapy for prostate cancer patients with old age or medical comorbidity: a 5-year follow-up of an investigational study. [2022]

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

A pilot study of intensity modulated radiation therapy with hypofractionated stereotactic body radiation therapy (SBRT) boost in the treatment of intermediate- to high-risk prostate cancer. [2022]

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

Stereotactic Body Radiation Therapy Boost for Intermediate-Risk Prostate Cancer: A Phase 1 Dose-Escalation Study. [2021]