Radiation Therapy for Prostate Cancer

Recruiting at 5 trial locations

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Chemotherapy

Disqualifiers: High-risk prostate cancer, Metastatic disease, Prior prostate treatment, others

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

Compensation: Varies

Number of Visits: 3

Duration: 2-3 weeks

144 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial evaluates changes in quality of life after two treatments with near margin-less adaptive radiation therapy (ART) compared to five treatments with standard stereotactic ablative body radiotherapy (SABR) in patients with prostate cancer that has not spread to other parts of the body (localized). ART is a type of radiation therapy that uses information gathered during the treatment cycle to inform, guide, and alter future radiation treatments with respect to location and dose. It may be able to deliver radiation to the site of disease over a shorter time and with smaller margins (less treatment delivered to nearby healthy tissues). SABR is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Shorter duration near margin-less ART may be just as effective at treating patients with localized prostate cancer but have less quality of life side effects than standard SABR.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those taking concurrent chemotherapy. It's best to discuss your specific medications with the trial coordinators.

What data supports the effectiveness of the treatment Near Margin-less Adaptive Radiation Therapy and Stereotactic Ablative Body Radiotherapy (SABR) for prostate cancer?

Research shows that Stereotactic Ablative Body Radiotherapy (SABR) is a promising treatment for prostate cancer, with studies indicating it is well-tolerated and potentially cost-effective, although more data is needed for high-risk patients. ^{1 2 3 4 5}

Is radiation therapy for prostate cancer safe?

Stereotactic ablative body radiotherapy (SABR) for prostate cancer has been shown to be generally safe and well-tolerated, especially for low- and intermediate-risk patients, with careful planning and setup techniques. ^{3 4 5 6 7}

How is the treatment Near Margin-less Adaptive Radiation Therapy different from other treatments for prostate cancer?

Near Margin-less Adaptive Radiation Therapy, also known as Stereotactic Ablative Body Radiotherapy (SABR), is a high-precision, non-invasive radiation treatment that delivers high doses similar to brachytherapy but with potentially fewer side effects. It is cheaper, uses fewer resources, and may improve quality of life compared to other radiation techniques, although more research is needed to confirm its long-term effectiveness. ^{1 3 5 8 9}

Research Team

Mark Waddle

Principal Investigator

Mayo Clinic in Rochester

Eligibility Criteria

This trial is for men with localized prostate cancer, meaning the cancer hasn't spread. Participants should be suitable for and have not yet received radiation therapy. Specific details about who can join or reasons someone might be excluded aren't provided.

Inclusion Criteria

I am a man aged 18 or older.

Ability to complete questionnaire(s) by themselves or with assistance

My prostate cancer is considered low to intermediate risk.

Exclusion Criteria

My cancer has spread to other parts of my body, confirmed by scans.

Body weight > 200 kilogram

I am not currently taking any cancer drugs.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo either near margin-less ART for 2 treatments or standard SABR for 5 treatments, with imaging studies such as CBCT, CT, and/or MRI

2-3 weeks

2-5 visits (in-person)

Follow-up

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

60 months

Visits at months 1, 3, 6, then every 6 months

Treatment Details

Interventions

• Near Margin-less Adaptive Radiation Therapy
• Standard Stereotactic Ablative Body Radiotherapy

Trial Overview The study compares two types of radiation therapy: near margin-less Adaptive Radiation Therapy (ART) given in fewer treatments versus standard Stereotactic Ablative Body Radiotherapy (SABR) over more sessions. It aims to see if ART affects quality of life less than SABR while still being effective.

Participant Groups

Group I: Arm I (near margin-less ART) Experimental Treatment 5 Interventions

Patients undergo near margin-less ART for 2 treatments at least 3 days apart in the absence of disease progression or unacceptable toxicity. Patients also undergo CBCT and may undergo CT and/or MRI on study.

Group II: Arm II (standard SABR) Active Control 4 Interventions

Patients undergo standard SABR for 5 treatments at least 2 days apart in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or MRI on study.

Near Margin-less Adaptive Radiation Therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Stereotactic Body Radiotherapy (SBRT) for:

• Localized prostate cancer

Approved in European Union as Stereotactic Ablative Body Radiotherapy (SABR) for:

• Localized prostate cancer
• High-risk prostate cancer

Approved in Canada as Adaptive Radiation Therapy (ART) for:

• Localized prostate cancer

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

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]

In a study involving 44 prostate cancer patients, both multileaf collimator (MLC) tracking and beam gating were effective in delivering accurate doses during Stereotactic Ablative Radiotherapy (SABR), improving treatment precision compared to no motion adaptation.

While both methods showed similar dosimetric performance, MLC tracking had the advantage of fewer treatment interruptions compared to gating, which required an average of 0.5 couch shifts and caused delays of about 1.8 minutes per fraction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is multileaf collimator tracking or gating a better intrafraction motion adaptation strategy? An analysis of the TROG 15.01 stereotactic prostate ablative radiotherapy with KIM (SPARK) trial. Hewson, EA., Nguyen, DT., O'Brien, R., et al.[2022]

Stereotactic ablative radiotherapy (SABR) has been shown to be feasible and well tolerated for low- and intermediate-risk prostate cancer patients, with promising results from large randomized studies comparing it to conventional treatments.

While SABR shows potential benefits and cost-effectiveness, there is currently insufficient data to recommend its use for high-risk prostate cancer patients outside of clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Body Radiotherapy for Intermediate- or High-Risk Prostate Cancer. Loblaw, A.[2021]

Stereotactic ablative body radiotherapy (SABR) is a feasible and well-tolerated treatment for patients with bone-only oligometastatic breast cancer, with 80% of patients successfully receiving treatment and no severe (grade 3 or 4) toxicities reported.

The treatment showed promising efficacy, with a 100% local progression-free survival (LPFS) and 67% distant progression-free survival (DPFS) at two years, suggesting that SABR could be a viable option for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy (SABR) for bone only oligometastatic breast cancer: A prospective clinical trial. David, S., Tan, J., Savas, P., 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]

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]

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 body radiation (SABR) is a promising non-invasive treatment for localized prostate cancer, showing similar efficacy to brachytherapy in terms of disease control and lower side effects, making it a potentially safer option.

SABR is also more cost-effective and resource-efficient compared to traditional radiation techniques, but further well-powered studies are needed to confirm its benefits before it can be considered standard care, especially for patients with metastatic disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy in patients with prostate cancer. Loblaw, A., Liu, S., Cheung, P.[2023]

In a study of 87 men with oligometastatic prostate cancer treated with stereotactic ablative radiotherapy (SABR), the median disease-free survival (DMFS) was 21.8 months for hormone-sensitive patients, indicating a significant benefit from this treatment.

Combining SABR with short-term androgen-deprivation therapy improved both biochemical progression-free survival (bPFS) and DMFS in patients with oligorecurrent hormone-sensitive prostate cancer, suggesting a potential strategy for enhancing treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survival Outcomes and Pattern of Relapse After SABR for Oligometastatic Prostate Cancer. Mercier, C., Claessens, M., De Troyer, B., et al.[2022]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Dosimetric and patient correlates of quality of life after prostate stereotactic ablative radiotherapy. [2018]

2. Ireland pubmed.ncbi.nlm.nih.gov

Is multileaf collimator tracking or gating a better intrafraction motion adaptation strategy? An analysis of the TROG 15.01 stereotactic prostate ablative radiotherapy with KIM (SPARK) trial. [2022]

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

Stereotactic Ablative Body Radiotherapy for Intermediate- or High-Risk Prostate Cancer. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy (SABR) for bone only oligometastatic breast cancer: A prospective clinical trial. [2020]

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

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

6. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Stereotactic ablative radiotherapy with CyberKnife in the treatment of locally advanced prostate cancer: preliminary results. [2017]

8. China pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy in patients with prostate cancer. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Survival Outcomes and Pattern of Relapse After SABR for Oligometastatic Prostate Cancer. [2022]