SBRT vs Hypofractionated Radiotherapy for Recurrent Prostate Cancer

Recruiting at 5 trial locations

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: Mayo Clinic

Disqualifiers: Previous pelvic radiation, Prior chemotherapy, Active rectal diverticulitis, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 9

Duration: 1-6 weeks

118 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two types of radiation therapy to determine which is more effective for treating prostate cancer that has recurred or spread to a few locations. One type, Stereotactic Body Radiation Therapy (SBRT), uses precise beams of radiation over a short period. The other, Hypofractionated Radiation Therapy, delivers higher doses over a longer time. The goal is to determine if SBRT can treat the cancer as effectively but with fewer side effects and a shorter treatment duration. The study seeks men with prostate cancer that has returned or spread to up to five sites (oligometastatic). As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both stereotactic body radiation therapy (SBRT) and hypofractionated radiation therapy (HFRT) are generally safe and well-tolerated for prostate cancer treatment.

For SBRT, studies have found it to be a safe option for treating recurrent prostate cancer. Patients in these studies experienced side effects that were acceptable and mostly manageable, not causing major issues in daily life.

For HFRT, evidence from several studies with many patients shows similar results. A large analysis found that HFRT's side effects were similar to those from regular radiation therapy, indicating no additional problems compared to standard treatment.

Overall, both treatments have demonstrated safety with manageable side effects. This is encouraging for those considering participation in a clinical trial for recurrent or oligometastatic prostate cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for recurrent prostate cancer because they offer potentially more efficient and convenient options compared to traditional radiation therapy. Stereotactic Body Radiation Therapy (SBRT) is unique because it delivers high doses of radiation in just five sessions over 1-2 weeks, which is significantly shorter than conventional therapies that often require several weeks. Hypofractionated radiation therapy also stands out by condensing treatment into 20 sessions over 4-6 weeks, providing a quicker alternative to standard fractionation schedules. Both approaches aim to maintain effectiveness while reducing the treatment burden on patients, which is why they're generating interest in the medical community.

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

This trial will compare two treatments for recurrent prostate cancer: stereotactic body radiation therapy (SBRT) and hypofractionated radiation therapy. Research has shown that SBRT can effectively treat prostate cancer, even if it returns or spreads to a few areas, with studies indicating good cancer control and fewer side effects. Meanwhile, hypofractionated radiation therapy has also demonstrated strong results, providing a high survival rate, with 98% of patients surviving cancer-specific issues for five years. Both treatments in this trial aim to destroy cancer cells while causing minimal harm to healthy tissues, offering promising options for managing prostate cancer that recurs or spreads to a few places. ^{3 5 6 7 8}

Who Is on the Research Team?

Carlos E. Vargas, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for men with prostate adenocarcinoma that has either returned after initial treatment or spread to a few other places. Participants should have undergone some prior therapy and be able to undergo imaging tests like PET scans, bone scans, and MRIs.

Inclusion Criteria

My prostate cancer has spread to no more than 5 places.

My prostate cancer was confirmed through a tissue examination.

I can care for myself and am up and about more than 50% of my waking hours.

Exclusion Criteria

Major medical, addictive, or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and/or interfere with follow-up. (Consent by legal authorized representative is not permitted for this study)

I have had radiation therapy to my pelvic area before.

I have had chemotherapy for prostate cancer before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo either SBRT over 1-2 weeks or hypofractionated radiation therapy over 4-6 weeks

1-6 weeks

5 visits (SBRT) or 20 visits (hypofractionated)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Follow-up at 3 months, 12 months, annually until year 5, then every other year

What Are the Treatments Tested in This Trial?

Interventions

• Hypofractionated Radiation Therapy
• Stereotactic Body Radiation Therapy

Trial Overview

The study compares two radiation therapies: SBRT, which delivers precise doses over several days aiming to minimize damage to healthy tissue; versus hypofractionated radiotherapy, which gives higher doses in a shorter time frame potentially killing more tumor cells.

How Is the Trial Designed?

Group I: Group II (Hypofractionated radiation therapy) Experimental Treatment 6 Interventions

Patients undergo hypofractionated radiation therapy over 15-20 minutes once per day for a total of 20 treatments over 4-6 weeks in the absence of disease progression or unacceptable toxicity. Patients may receive androgen deprivation therapy for up to 18 months, as clinically indicated. Patients undergo PET at screening and treatment failure, and undergo blood sample collection throughout the study. Patients may also undergo MRI as clinically indicated at screening and treatment failure.

Group II: Group I (SBRT) Experimental Treatment 6 Interventions

Patients undergo SBRT over 15-20 minutes every other day for a total of 5 treatments over 1-2 weeks in the absence of disease progression or unacceptable toxicity. Patients may receive androgen deprivation therapy for up to 18 months, as clinically indicated. Patients undergo PET at screening and treatment failure, and blood sample collection throughout the study. Patients may also undergo MRI as clinically indicated at screening and treatment failure.

Hypofractionated Radiation Therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Hypofractionated Radiotherapy for:

• Soft tissue sarcoma
• Extremity soft tissue sarcoma

Approved in European Union as Hypofractionated Radiotherapy for:

• Soft tissue sarcoma
• Extremity soft tissue sarcoma

Approved in Canada as Hypofractionated Radiotherapy for:

• Soft tissue sarcoma
• Extremity soft tissue sarcoma

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

In a study involving 51 prostate cancer patients treated with stereotactic body radiotherapy (SBRT), the treatment showed promising outcomes with manageable toxicity levels, as no patients experienced severe (grade 3+) side effects during the initial follow-up period.

The median follow-up of 14.5 months revealed a low prostate-specific antigen level of 1.3 ng/ml at 13-18 months post-treatment, indicating effective disease control in this cohort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate stereotactic body radiotherapy—first UK experience. Tree, AC., Ostler, P., Hoskin, P., et al.[2022]

The CyberKnife (CK) system provided significantly better dose distribution for prostate cancer treatment compared to both volumetric arc radiotherapy (VMAT) and intensity-modulated radiotherapy (IMRT), with a higher mean planning target volume dose (39.58 Gy vs. 36.25 Gy).

CK resulted in a lower mean dose to the rectum, indicating improved safety for this organ, while also achieving better conformity and homogeneity indices, although VMAT and IMRT are still considered acceptable alternatives due to their comparable performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does CyberKnife improve dose distribution versus IMRT and VMAT on a linear accelerator in low-risk prostate cancer? Borowicz, DM., Skrobała, A., Kruszyna-Mochalska, M., et al.[2023]

In a study of 12 localized prostate cancer cases, Tomotherapy (HT) demonstrated superior dosimetric results compared to Cyberknife (CK), achieving better dose homogeneity, target coverage, and conformity, which are crucial for effective treatment.

HT also predicted lower late rectal toxicity and resulted in a significantly lower integral dose to the body, suggesting that it may offer clinical benefits by reducing the risk of side effects associated with radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric and radiobiological comparison of Cyberknife and Tomotherapy in stereotactic body radiotherapy for localized prostate cancer. Chen, CY., Lee, LM., Yu, HW., et al.[2018]

In a study of 67 patients with low-risk prostate cancer treated with stereotactic body radiotherapy (SBRT), significant late bladder and rectal toxicities were infrequent, with no grade 4 toxicities reported and only 3% experiencing grade 3 bladder toxicity.

The 4-year PSA relapse-free survival rate was 94%, indicating that SBRT is effective in controlling prostate cancer and should be considered as a treatment option alongside other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcomes from a prospective trial of stereotactic body radiotherapy for low-risk prostate cancer. King, CR., Brooks, JD., Gill, H., et al.[2022]

In a study of 304 prostate cancer patients treated with CyberKnife stereotactic body radiotherapy (SBRT), the treatment demonstrated excellent biochemical control rates, with 97% of low-risk, 90.7% of intermediate-risk, and 74.1% of high-risk patients remaining free from biochemical recurrence at 5 years.

The treatment was associated with low toxicity, as no patients experienced severe acute complications, and only a small percentage had Grade II urinary or rectal toxicities, indicating that SBRT is a safe and effective option for prostate cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for localized prostate cancer: disease control and quality of life at 6 years. Katz, AJ., Santoro, M., Diblasio, F., et al.[2021]

A systematic review of studies on stereotactic body radiation therapy (SBRT) for prostate cancer found that most patients experienced mild to moderate side effects, with severe toxicity occurring in less than 3% of cases, indicating that SBRT is generally well tolerated.

The review identified important dosimetric factors that influence toxicity, such as recommended dose constraints for the bladder, urethra, and rectum, which can help optimize treatment safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate Stereotactic Body Radiation Therapy: An Overview of Toxicity and Dose Response. Wang, K., Mavroidis, P., Royce, TJ., et al.[2022]

In a study of 41 low-risk prostate cancer patients treated with hypofractionated stereotactic body radiotherapy (SBRT), the 5-year biochemical progression-free survival rate was an impressive 93%, indicating strong efficacy of this treatment.

The treatment was well-tolerated, with acute side effects resolving within 1-3 months and no severe (grade 4) toxicities reported, highlighting the safety of SBRT for localized prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for low-risk prostate cancer: five-year outcomes. Freeman, DE., King, CR.[2022]

In a study involving 24 patients with intermediate- to high-risk prostate cancer, hypofractionated stereotactic body radiation therapy (SBRT) using the CyberKnife system showed promising results, with a significant decrease in median PSA levels from 10.6 ng/ml to 1.5 ng/ml within 6 months post-treatment.

The treatment was well tolerated, with only mild acute urinary and gastrointestinal toxicities reported, and no severe Grade 3 or greater toxicities, indicating a favorable safety profile for this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of intensity modulated radiation therapy with hypofractionated stereotactic body radiation therapy (SBRT) boost in the treatment of intermediate- to high-risk prostate cancer. Oermann, EK., Slack, RS., Hanscom, HN., et al.[2022]

In a study of 41 patients with high-risk localized prostate cancer, combining whole-pelvis irradiation with a stereotactic body radiotherapy (SBRT) boost resulted in a high 4-year biochemical failure-free survival rate of 91.9%, indicating effective cancer control.

The treatment was associated with minimal toxicity, with no severe (grade 3) gastrointestinal or genitourinary side effects reported, suggesting that this approach is safe for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The early result of whole pelvic radiotherapy and stereotactic body radiotherapy boost for high-risk localized prostate cancer. Lin, YW., Lin, LC., Lin, KL.[2020]

Citations

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pmc.ncbi.nlm.nih.gov

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Hypofractionated Radiotherapy in Prostate Cancer

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asco.org

asco.org/abstracts-presentations/ABSTRACT185918

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Results: Median follow-up was 54 months (range 11-116 months). The actuarial 8-years Overall Survival was 97.1%. Eight-years Cancer Specific Survival was 100%, ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12548115/

evidence from 9074 men in 13 randomized clinical trials

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7.

sciencedirect.com

sciencedirect.com/science/article/pii/S0360301625016347

Conventional vs. Hypofractionated, Radiotherapy for High- ...

At 10 years of follow up there were no significant differences in survival outcomes between HFRT and CFRT for overall mortality (68.2% vs. 66%; RR 1.04 [0.87- ...

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Hypofractionated Radiation for High-Risk Prostate Cancer ...

At 5 years, rates of overall survival (90.3% vs 89.7%), prostate cancer-specific survival (97.4% vs 97.5%), biochemical recurrence-free ...