Stereotactic Body Radiation Therapy for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: City of Hope Medical Center

Must not be taking: Biological chemotherapy

Disqualifiers: Prior malignancies, Prior pelvic radiation, 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: 90

Duration: 1.5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to study the side effects and optimal dose of Stereotactic Body Radiation Therapy (SBRT), a specialized radiation therapy that targets prostate cancer more precisely, potentially sparing healthy tissue. It is intended for individuals treated for prostate cancer with surgery who may still require further treatment. Participants should show no signs of cancer spread to other areas, and conditions such as prior pelvic radiation or uncontrolled bowel disease will make someone ineligible. Those who have undergone prostatectomy and have residual cancer concerns may find this trial suitable. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

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 cannot be on any investigational drugs or biological chemotherapy while participating.

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. One study found SBRT effective, with only 2.25% of patients experiencing significant side effects, indicating that most handle the treatment well.

Another study compared SBRT to traditional radiation and found no major differences in survival rates, suggesting that SBRT does not increase risks. Long-term results are also positive, with most patients remaining disease-free several years after treatment.

Overall, these studies indicate that SBRT is a safe option for treating prostate cancer. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Stereotactic Body Radiation Therapy (SBRT) is unique because it delivers high doses of radiation directly to prostate cancer tumors with pinpoint accuracy, minimizing damage to surrounding healthy tissue. Unlike conventional radiation therapy, which typically requires daily sessions over several weeks, SBRT can be completed in just five treatments over approximately one and a half weeks. Researchers are excited about SBRT because this condensed treatment schedule not only offers convenience for patients but also has the potential to maintain or even improve effectiveness compared to traditional methods.

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

Research has shown that stereotactic body radiation therapy (SBRT) is effective for treating prostate cancer. In this trial, participants will receive SBRT, which studies have demonstrated to be safe and manageable for patients with low- and intermediate-risk prostate cancer, particularly with the CyberKnife System. For instance, one study with 122 patients administered SBRT in doses of 35 Gy or 36.25 Gy over five sessions, proving its effectiveness. The treatment has shown only small differences in survival rates compared to traditional radiation methods, indicating it works just as well. Additionally, long-term results have confirmed that SBRT effectively controls cancer over time. Overall, SBRT is a promising option for treating prostate cancer. ^{1 2 3 6 7}

Who Is on the Research Team?

Sagus Sampath

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

Men who've had prostate cancer surgery can join this trial. They should be in decent physical shape (ECOG 0-2), have no signs of cancer spread based on recent scans, and a PSA level up to 2.0. Men with certain high-risk features from their surgery are also eligible. Those with uncontrolled illnesses, other cancers within the last 5 years (except skin cancer), or taking experimental treatments can't join.

Inclusion Criteria

Eastern Cooperative Oncology Group (ECOG) performance scale 0-2

History of diagnosis of prostate cancer after undergoing prostatectomy

No evidence of regional nodal or distant metastases based on computed tomography (CT) abdomen and pelvis and whole body bone scan within 120 days prior to study entry; nodes less than 1.5 cm will be considered reactive and biopsy is not required; nodes 1.5 cm or larger are required to undergo biopsy and be negative prior to study registration; bone scan findings in the absence of blastic or lytic lesion correlates on CT imaging will also be deemed non-neoplastic

Exclusion Criteria

Patients should not have any uncontrolled illness including ongoing or active infection

Patients may not be receiving any other investigational agents, or concurrent biological chemotherapy

Patients with history of prior malignancies (with exception to non-melanoma skin cancer) are ineligible for this study, unless they are documented to be disease-free for at least 5 years

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive 5 fractions of stereotactic body radiation therapy (SBRT) over 1.5 weeks

1.5 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

Follow-up at 90 days and then periodically for 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Stereotactic Body Radiation Therapy

Trial Overview

The trial is testing how safe and effective stereotactic body radiation therapy is for prostate cancer patients post-surgery. It's looking for the best dose that targets the tumor while sparing healthy tissue, alongside assessing quality-of-life and analyzing biomarkers.

How Is the Trial Designed?

Group I: Treatment (SBRT) Experimental Treatment 3 Interventions

Patients receive 5 fractions of SBRT over 1.5 weeks.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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.

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 ...

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.

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%, ...

7.

thegreenjournal.com

thegreenjournal.com/issue/S0167-8140(25)X0003-7?pageStart=26

May 2025

Prostate cancer focal boost versus no boost in 20 fraction external beam radiotherapy: a prospective cohort on dosimetry, toxicity and quality of life