SBRT vs IMRT for Prostate Cancer

Recruiting at 332 trial locations

Overseen By Vivek S. Kavadi

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: NRG Oncology

Must not be taking: Hormonal therapy

Disqualifiers: Metastatic disease, T3 disease, 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: 11

Duration: 6-7 weeks

698 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

If you are taking a 5-alpha reductase inhibitor, you will need to stop it before starting the trial, but no specific time without the medication is required. Other medications are not mentioned, so the protocol does not specify if you need to stop them.

What data supports the effectiveness of the treatment SBRT vs IMRT for Prostate Cancer?

Research shows that combining IMRT with SBRT for prostate cancer can improve survival rates and maintain quality of life, with low rates of severe side effects. SBRT is also noted for its shorter treatment duration and cost-effectiveness compared to IMRT. ^{1 2 3 4 5}

Is SBRT or IMRT safe for treating prostate cancer?

Research shows that both SBRT and IMRT are generally safe for treating prostate cancer, with low rates of severe side effects. Patients report maintaining a good quality of life, and studies indicate low levels of gastrointestinal (stomach and intestines) and genitourinary (urinary and reproductive organs) side effects. ^{1 2 3 4 6}

How does the treatment SBRT differ from IMRT for prostate cancer?

SBRT (Stereotactic Body Radiation Therapy) is unique because it offers a shorter treatment duration and potentially lower cost compared to IMRT (Intensity-Modulated Radiation Therapy). SBRT can deliver a higher dose of radiation in fewer sessions, which may lead to different toxicity profiles and patient experiences. ^{1 2 3 5 7}

What is the purpose of this trial?

This randomized phase III trial studies how well stereotactic body radiation therapy works compared to intensity-modulated radiation therapy in treating patients with stage IIA-B prostate cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Stereotactic body radiation therapy may work better in treating patients with prostate cancer.

Research Team

Rodney Ellis

Principal Investigator

NRG Oncology

Eligibility Criteria

Men with early-stage prostate cancer (stage IIA-B) who haven't had previous treatments are eligible. They must have a prostate size less than 70 cc, specific PSA levels depending on their Gleason score, and be in good physical condition. Men over 60 can have slightly more health issues. Only English, Spanish, and French speakers who agree to fill out questionnaires can join.

Inclusion Criteria

I have prostate cancer that has not spread and hasn't been treated yet.

Willingness and ability to complete the Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire

Completion of all items of the EPIC-26 at registration 60 days prior to registration

Exclusion Criteria

Presence of specific surgically implanted devices

I haven't had chemotherapy for my cancer in the last 3 years.

I have not had radiotherapy in areas that would be treated in this study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo either IMRT or SBRT radiation therapy

6-7 weeks

5 visits per week for IMRT, 2-3 visits per week for SBRT

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

Every 6-12 months

Treatment Details

Interventions

• Intensity-Modulated Radiation Therapy (IMRT)
• Stereotactic Body Radiation Therapy (SBRT)

Trial Overview The trial is comparing two types of radiation therapy for prostate cancer: Stereotactic Body Radiation Therapy (SBRT), which targets the tumor with high precision over a few days, and Intensity-Modulated Radiation Therapy (IMRT), which shapes radiation beams to the tumor's contours.

Participant Groups

Group I: Stereotactic Body Radiation Therapy (SBRT) Experimental Treatment 1 Intervention

Patients undergo Stereotactic Body Radiation Therapy (SBRT) at least every other day for 2-3 fractions per week for 5 fractions over less than 12 business days.

Group II: Intensity-Modulated Radiation Therapy (IMRT) Active Control 1 Intervention

Patients undergo Intensity-Modulated Radiation Therapy (IMRT) once daily 5 fractions per week for 28 fractions over less than 32 business days.

Who Is Running the Clinical Trial?

NRG Oncology

Lead Sponsor

Trials

242

Recruited

105,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Stereotactic body radiation therapy (SBRT) for localized prostate cancer showed similar 5-year survival rates (90.8% for SBRT vs. 88.1% for IMRT) and comparable freedom from biochemical failure (FFBF) rates, indicating its efficacy is on par with intensity-modulated radiation therapy (IMRT).

Both treatment methods had low toxicity, with no severe (grade 3 or higher) side effects reported, suggesting that SBRT is a safe alternative that offers the benefits of shorter treatment duration and lower costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Propensity score matched comparison of SBRT versus IMRT for the treatment of localized prostate cancer. Oliai, C., Bernetich, M., Brady, L., et al.[2022]

Stereotactic body radiation therapy (SBRT) resulted in significantly lower post-treatment PSA levels compared to intensity-modulated radiation therapy (IMRT) at 2 and 3 years, indicating better efficacy in controlling prostate cancer.

Both SBRT and IMRT showed similar overall survival rates after 5 years, but SBRT offers advantages such as lower cost and easier application, making it a suitable alternative for treating localized prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Stereotactic body radiation therapy versus conventional intensity-modulated radiation therapy for the treatment of prostate cancer]. Gao, QN.[2022]

In a study of 205 prostate cancer patients treated with stereotactic body radiation therapy (SBRT), 99% completed the treatment without severe acute side effects, indicating that this method is safe and well-tolerated.

The most common acute side effects were mild to moderate, with 50.7% experiencing grade II genitourinary issues and 31.7% experiencing grade I gastrointestinal issues, but no patients had severe (grade ≥ 4) toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute side effects after definitive stereotactic body radiation therapy (SBRT) for patients with clinically localized or locally advanced prostate cancer: a single institution prospective study. Jorgo, K., Polgar, C., Stelczer, G., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Intensity modulated radiation therapy with stereotactic body radiation therapy boost for unfavorable prostate cancer: five-year outcomes. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Intensity-Modulated Radiation Therapy with Stereotactic Body Radiation Therapy Boost for Unfavorable Prostate Cancer: A Report on 3-Year Toxicity. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Propensity score matched comparison of SBRT versus IMRT for the treatment of localized prostate cancer. [2022]

4. China pubmed.ncbi.nlm.nih.gov

[Stereotactic body radiation therapy versus conventional intensity-modulated radiation therapy for the treatment of prostate cancer]. [2022]

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

The early adoption of intensity-modulated radiotherapy and stereotactic body radiation treatment among older Medicare beneficiaries with prostate cancer. [2020]

6. Poland pubmed.ncbi.nlm.nih.gov

Acute side effects after definitive stereotactic body radiation therapy (SBRT) for patients with clinically localized or locally advanced prostate cancer: a single institution prospective study. [2022]

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

Stereotactic body radiation therapy versus intensity-modulated radiation therapy for prostate cancer: comparison of toxicity. [2022]