Stereotactic Body Radiation for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Jonsson Comprehensive Cancer Center

Must not be taking: Hormonal therapy

Disqualifiers: Distant metastases, Crohn's, Ulcerative colitis, others

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

220 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special type of radiation therapy called stereotactic body radiation therapy (SBRT) for patients with high-risk prostate cancer that hasn't spread beyond the prostate. The aim is to determine if SBRT can effectively target and kill cancer cells while minimizing damage to healthy tissue. Researchers also seek to understand how this treatment affects patients' long-term quality of life. This trial suits individuals diagnosed with high-risk prostate cancer without cancer in their lymph nodes or other parts of their body. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could enhance future treatment options.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on hormonal therapy for more than 4 months, you may not be eligible to participate.

What prior data suggests that stereotactic body radiation therapy is safe for treating prostate cancer?

Research has shown that stereotactic body radiation therapy (SBRT) is generally safe and well-tolerated for treating prostate cancer. In past studies, patients with low and intermediate-risk prostate cancer had positive experiences with this treatment. Only about 2.25% of patients reported significant side effects, indicating that most manage it well. Other research suggests that SBRT does not cause more long-term side effects or negatively affect quality of life compared to traditional radiation treatments. Overall, SBRT appears to be a promising option for consideration. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Stereotactic Body Radiation Therapy (SBRT) is unique because it delivers highly focused radiation doses directly to the prostate cancer cells, minimizing damage to surrounding healthy tissue. Unlike traditional radiation treatments, which often require daily sessions over several weeks, SBRT compresses the therapy into just five sessions over 14 days. This approach not only reduces the overall treatment time but also potentially enhances patient convenience and quality of life. Researchers are excited about SBRT because it offers the precision of advanced technology, which could lead to fewer side effects and improved outcomes for patients.

What evidence suggests that stereotactic body radiation therapy is effective for prostate cancer?

Research has shown that stereotactic body radiation therapy (SBRT), which participants in this trial will receive, works well for prostate cancer. Studies have found that SBRT, administered in just five sessions, controls cancer as effectively as standard radiation therapy. For patients with low- and intermediate-risk prostate cancer, SBRT has demonstrated promising results. This treatment delivers high doses of radiation directly to the tumor, helping to kill cancer cells while protecting healthy tissue. Long-term evidence also suggests that SBRT remains effective over time. Overall, SBRT offers a strong option for treating prostate cancer, providing a quicker treatment with similar success rates to traditional methods. ^{2 4 6 7 8}

Who Is on the Research Team?

Amar Kishan

Principal Investigator

Jonsson Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for men with high-risk prostate cancer that hasn't spread beyond the prostate or to lymph nodes. Participants must have a Karnofsky performance status of 70 or above, indicating they can care for themselves. They should not have had extensive hormone therapy, prior cryosurgery, HIFU, brachytherapy, pelvic radiotherapy, nor suffer from Crohn's disease or Ulcerative colitis.

Inclusion Criteria

I have chosen SBRT as my main cancer treatment.

Ability to understand, and willingness to sign, the written informed consent

I am able to care for myself but may not be able to do active work.

Exclusion Criteria

I have been on hormonal therapy for more than 4 months.

I have had radiation therapy to my pelvic area before.

I have a history of Crohn's disease or Ulcerative colitis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo SBRT daily or every other day for a total of 5 fractions not exceeding 14 consecutive days. Patients may also receive androgen deprivation therapy for up to 9 months at the discretion of the treating physician.

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year with visits every 4 months, then every 6 months for 5 years, and annually thereafter

What Are the Treatments Tested in This Trial?

Interventions

• Stereotactic Body Radiation Therapy

Trial Overview The study tests stereotactic body radiation therapy (SBRT) on patients with localized high-risk prostate cancer. SBRT delivers a concentrated dose of radiation aiming to kill more tumor cells while sparing healthy tissue. The trial also assesses how this treatment affects patients' quality of life and monitors changes through lab biomarker analysis.

How Is the Trial Designed?

Group I: Treatment (SBRT) Experimental Treatment 4 Interventions

Patients undergo SBRT daily or every other day for a total of 5 fraction not exceeding 14 consecutive days. Patients may also receive androgen deprivation therapy for up to 9 months at the discretion of the treating physician.

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?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

Published Research Related to This Trial

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]

Stereotactic ablative body radiotherapy (SABR) is an advanced treatment that delivers high doses of radiation in fewer sessions while protecting surrounding healthy tissues, making it effective for small tumors in various locations, including the prostate.

SABR is becoming a standard treatment for low and intermediate-risk prostate cancer, supported by research from Sunnybrook and the US prostate SABR consortium, highlighting its efficacy in improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolution of hypofractionated accelerated radiotherapy for prostate cancer - the sunnybrook experience. Musunuru, HB., Cheung, P., Loblaw, A.[2022]

In a study of 100 patients with early-stage non-small cell lung cancer (NSCLC) treated with stereotactic ablative body radiotherapy (SABR), the 1-, 2-, and 3-year local control rates were 100%, 93.55%, and 84.33%, respectively, indicating high efficacy in tumor control.

The treatment was associated with low toxicity, with only 2% of patients experiencing Grade-3 side effects, suggesting that SABR is a safe option for patients who are inoperable or refuse surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Definitive Treatment of Early-Stage Non-Small Cell Lung Cancer with Stereotactic Ablative Body Radiotherapy in a Community Cancer Center Setting. Heal, C., Ding, W., Lamond, J., et al.[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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10660677/

Stereotactic body radiotherapy with CyberKnife® System ... A total of 122 patients with low- and intermediate-risk prostate cancer were treated with the CyberKnife System at a dose of 35 Gy or 36.25 Gy in five fractions ...

2. thegreenjournal.com thegreenjournal.com/issue/S0167-8140(25)X0003-7?pageStart=28

May 2025 Adoption of hypofractionation radiotherapy for localised prostate cancer and quality of life outcomes in an Australian population-based cohort

3. sciencedirect.com sciencedirect.com/science/article/pii/S2773160X25000078

The effectiveness and safety of stereotactic body ... The results show minor, non-significant differences in survival rates compared to conventional fractionation, a type of external radiation, after two and five ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2723641

Long-term Outcomes of Stereotactic Body Radiotherapy for ... This cohort study of pooled individual patient data assesses long-term outcomes after stereotactic body radiotherapy for low-risk and ...

5. cancer.gov cancer.gov/news-events/cancer-currents-blog/2024/prostate-cancer-sbrt-effective-safe

SBRT Proves Effective for Some Prostate Cancers - NCI But it had to be confirmed that a 5-day course of SBRT was not worse at controlling cancer than standard radiation therapy and also that it does ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5494208/

Cyberknife Radioablation of Prostate Cancer Stereotactic ablative radiotherapy of low and intermediate risk prostate cancer patients is a safe, well-tolerated and effective treatment modality (2.25% of ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11844808/

Current State of Stereotactic Body Radiation Therapy for ... Several phase II randomized trials have revealed that once-weekly SBRT does not seem to have superior long-term toxicity or quality-of-life profiles compared ...

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

and intermediate-risk prostate cancer: clinical outcomes ... Results: The 1-, 2-, and 5-year DFS rates were 92.9%, 92.9%, and 92.3%, respectively, while the 1-, 2-, and 5-year bDFS rates were 100%, 100%, and 95.7%, ...