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

26 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase I trial studies the side effects and best dose of stereotactic body radiation therapy in treating patients with prostate cancer after undergoing surgery. Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

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 data supports the effectiveness of the treatment Stereotactic Body Radiation Therapy for Prostate Cancer?

Research shows that Stereotactic Ablative Radiotherapy (SABR) using the CyberKnife system is promising for treating prostate cancer, with encouraging results in low-risk cases and ongoing evaluation for higher-risk cases. Additionally, SABR has been effective in treating other cancers, like early-stage lung cancer, suggesting its potential benefits for prostate cancer. ^{1 2 3 4 5}

Is Stereotactic Body Radiation Therapy (SBRT) safe for humans?

Research shows that Stereotactic Body Radiation Therapy (SBRT), also known as Stereotactic Ablative Radiotherapy (SABR) or CyberKnife, has been used safely in treating prostate cancer and lung cancer. Studies have reported encouraging safety results, but long-term safety data, especially at higher doses, is still limited. ^{1 2 3 5 6}

How does stereotactic body radiation therapy differ from other prostate cancer treatments?

Stereotactic body radiation therapy (SBRT) for prostate cancer is unique because it delivers high doses of radiation in a few sessions, targeting the cancer precisely while sparing surrounding healthy tissue. This approach, known as stereotactic ablative body radiotherapy (SABR), is particularly beneficial for treating small areas of cancer and is becoming a standard for low and intermediate-risk prostate cancer due to its effectiveness and reduced treatment time. ^{1 2 3 4 7}

Research Team

Sagus Sampath

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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]

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 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 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]

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]

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. Switzerland pubmed.ncbi.nlm.nih.gov

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

4. Switzerland 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. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Dose-Intensified Stereotactic Ablative Radiation for Localized Prostate Cancer. [2022]

6. Greece pubmed.ncbi.nlm.nih.gov

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

7. Switzerland pubmed.ncbi.nlm.nih.gov

Evolution of hypofractionated accelerated radiotherapy for prostate cancer - the sunnybrook experience. [2022]