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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two radiation therapy methods for treating localized prostate cancer. The goal is to determine if a shorter treatment, near margin-less adaptive radiation therapy (ART), can deliver effective results with fewer impacts on quality of life compared to the traditional method, stereotactic ablative body radiotherapy (SABR). Men diagnosed with low to intermediate-risk prostate cancer who have not yet received treatment might be suitable candidates.

As an unphased trial, this study allows patients to contribute to innovative research that could enhance future treatment options.

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 prior data suggests that these radiation therapy techniques are safe for treating localized prostate cancer?

Research shows that near margin-less adaptive radiation therapy (ART) is generally well-tolerated by patients. Studies have found that ART can lower the radiation dose to nearby healthy organs in prostate cancer patients, suggesting fewer side effects compared to traditional methods. ART effectively targets the cancer area while using smaller safety margins, reducing radiation exposure to healthy tissues.

Standard stereotactic ablative body radiotherapy (SABR) is a well-known treatment with a proven safety record. SABR accurately targets tumors, protecting normal tissue from excessive radiation. Both ART and SABR aim to reduce the risk of side effects while effectively treating cancer, making them promising options for patients with localized prostate cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for prostate cancer because they offer potentially more precise and efficient radiation options. Near margin-less Adaptive Radiation Therapy (ART) allows for highly targeted treatments by minimizing the margins around the tumor, which could reduce damage to surrounding healthy tissues. In contrast, standard Stereotactic Ablative Body Radiotherapy (SABR) is known for its precision but typically involves a higher number of sessions. By comparing these methods, researchers hope to determine if near margin-less ART can achieve similar or better outcomes with fewer treatments and less toxicity.

What evidence suggests that this trial's treatments could be effective for localized prostate cancer?

Research has shown that a new method called near margin-less adaptive radiation therapy (ART), which participants in this trial may receive, could effectively treat localized prostate cancer. Studies have found that ART delivers radiation with smaller safety margins, targeting the cancer more precisely and sparing healthy tissue. This precision could help maintain a patient's quality of life by reducing side effects. Early findings also suggest that ART might control tumors as well as other radiation methods but with fewer treatments. Meanwhile, standard stereotactic ablative body radiotherapy (SABR), another treatment option in this trial, is already known for precisely targeting tumors while protecting normal tissue. Both treatments offer promising ways to manage prostate cancer and prevent its spread. ^{3 5 6 7 8}

Who Is on the Research Team?

Mark Waddle

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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 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]

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]

Citations

1. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-01669

Evaluating Changes in Quality of Life after Near Margin ... This clinical trial evaluates changes in quality of life after two treatments with near margin-less adaptive radiation therapy (ART) compared to five ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06325046?term=John

Adaptive Radiation Therapy (ART) Stereotactic Ablative ... 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3664920/

Adaptive Radiation Therapy for Prostate Cancer - PMC Their data demonstrated equivalent tumor control achieved using either 10-mm margin or 15-mm margin, suggesting that a 10-mm margin may be sufficient for CRT.

4. advancesradonc.org advancesradonc.org/article/S2452-1094(24)00264-1/fulltext

First-in-Men Online Adaptive Robotic Stereotactic Body ... Online adaptive radiation therapy could potentially reduce this margin. This paper focuses on the development, preclinical validation, and clinical testing of ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1879850022003666

Preliminary Evaluation of PTV Margins for Online Adaptive ... Online daily adaptive radiation therapy could significantly decrease PTV margins for prostatic PORT and improve rectal dosimetry.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12210003/

Online CBCT-based adaptive radiation with reduced PTV ... Margin reduction using online ART has been shown to lead to lower doses to OARs in bladder cancer, anal canal, rectal cancer and prostate cancer (using MRI- ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1120179724001637

Evaluation of safety margins for cone beam CT-based ... Recent publications have shown that a good CTV coverage (>95 %) can be achieved with reduced PTV margins in prostate Online Adaptive Radiotherapy (OART) by ...

8. thegreenjournal.com thegreenjournal.com/article/S0167-8140(24)00099-9/abstract

In silico evaluation and feasibility of near margin-less head ... Our findings support the safe, delivery of ART treatments, contributing to evidence for treatment de-intensification, with an ongoing phase II trial examining ...