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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a special type of radiation treatment, called CyberKnife, can improve the lives of people with prostate cancer. Participants will first receive typical hormone therapy and regular radiation, followed by a focused CyberKnife radiation boost to the prostate. The trial aims to determine if this approach enhances treatment outcomes and maintains quality of life. Men diagnosed with prostate cancer, who are undergoing or planning to undergo standard treatments, and have specific cancer characteristics (such as certain PSA levels or Gleason scores) may be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve future prostate cancer treatments.

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 prior data suggests that the CyberKnife Boost is safe for prostate cancer treatment?

Research has shown that CyberKnife, a type of precise radiation therapy, is generally well-tolerated. In studies, almost all patients managed the treatment well, with only about 0.8% experiencing serious urinary side effects both shortly after and later in the treatment.

Other studies have also demonstrated low levels of harmful side effects. Many patients reported improvements in their quality of life. These findings suggest that CyberKnife is a safe option for treating prostate cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CyberKnife Boost for prostate cancer because it offers a precise and targeted approach to delivering radiation therapy. Unlike traditional radiation treatments that can take several weeks to complete, the CyberKnife Boost administers high doses of radiation in just three sessions, every other day. This method not only shortens the treatment duration but also aims to minimize damage to surrounding healthy tissue, potentially reducing side effects. By focusing the radiation more accurately, it provides a promising alternative to standard options like external beam radiation therapy or brachytherapy.

What evidence suggests that the CyberKnife Boost is effective for prostate cancer?

Research shows that using the CyberKnife for treating prostate cancer can be very effective. In this trial, participants will receive a CyberKnife Boost, delivering 21 Gy in 7 Gy per day over 3 fractions, every other day. Studies have found excellent survival rates without the disease at five and ten years for patients with low to intermediate risk. Patients reported fewer severe prostate symptoms compared to other treatments. The CyberKnife also reduces side effects related to the stomach and urinary systems. Overall, early evidence suggests that the CyberKnife is a promising tool for precisely targeting prostate cancer. ^{1 2 5 6 7}

Who Is on the Research Team?

Ariel E. Hirsch

Principal Investigator

Boston Medical Center

Are You a Good Fit for This Trial?

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.

I have not had prostate surgery or treatment, except for hormone therapy.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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 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 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 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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8557180/

Five-year outcomes of stereotactic body radiation therapy ... To evaluate the efficacy and safety of SBRT for localized prostate cancer (PCa) with CyberKnife in China. Moreover, it is the largest-to-date pilot study to ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0360301624004255

Simultaneous Focal Boost With Stereotactic Radiation ... This study evaluated the toxicity and quality of life (QoL) with CyberKnife-based SBRT and simultaneous integrated boost in localized prostate cancer.

3. accuray.com accuray.com/case-studies/largest-clinical-studies-to-date-support-cyberknife-sbrt-for-localized-prostate-cancer/

Largest Clinical Studies to Date* Support CyberKnife ... EFFECTIVE · Excellent disease-free survival rates at five and 10-years for low-intermediate risk patients · Reduced gastrointestinal and genitourinary toxicities ...

4. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2024.1325200/full

High-risk prostate cancer treated with a stereotactic body ... Utilization of an SBRT boost following pelvic nodal irradiation in the treatment of high-risk prostate cancer is oncologically effective with early follow-up.

5. ro-journal.biomedcentral.com ro-journal.biomedcentral.com/articles/10.1186/s13014-023-02233-4

Stereotactic body radiation therapy for prostate cancer: a study ... Patient reports indicated that CyberKnife can significantly reduce peak prostate symptoms compared to VMAT. Physician-reported GU toxicity ...

6. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2023.1270498/full

and intermediate-risk prostate cancer: clinical outcomes ... Dixit evaluated the health-related QoL outcomes among 45 prostate cancer patients following SBRT with CyberKnife. The mean GHS score improved from 81.3 at ...

7. redjournal.org redjournal.org/article/S0360-3016(25)03438-8/fulltext

CyberKnife Stereotactic Body Radiation Therapy (SBRT ... Median baseline PSA was 6.5, with a median of 42% positive cores. 85% of our patients had unfavorable intermediate risk prostate cancer. The median duration of ...