SBRT vs IMRT for Prostate Cancer

Not currently recruiting at 350 trial locations
VS
Overseen ByVivek S. Kavadi
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how two types of radiation therapy, stereotactic body radiation therapy (SBRT) and intensity-modulated radiation therapy (IMRT), treat stage IIA-B prostate cancer. Both treatments use high-energy x-rays to target and kill cancer cells, but SBRT aims to achieve this with fewer sessions and less harm to healthy tissue. The trial will determine which method is more effective for patients. Men diagnosed with localized prostate cancer who have not received prior local treatment, such as surgery or radiation, might be suitable candidates for this study. As a Phase 3 trial, it represents the final step before FDA approval, offering patients a chance to contribute to potentially groundbreaking treatment advancements.

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.

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

Studies have shown that both stereotactic body radiation therapy (SBRT) and intensity-modulated radiation therapy (IMRT) are safe for treating prostate cancer. SBRT delivers precise radiation to tumors and generally causes manageable side effects. One study found that 27% of men experienced urinary problems, slightly more than those receiving standard radiation therapy, though these issues were not severe for most patients.

IMRT, a common treatment, is usually well-tolerated. It targets cancer cells while protecting healthy tissue, reducing side effects. Both treatments use high-energy x-rays to destroy cancer cells, but SBRT achieves this in fewer sessions. Overall, research indicates that both SBRT and IMRT are safe options for patients with stage IIA-B prostate cancer.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they offer different approaches to delivering radiation therapy for prostate cancer. Intensity-Modulated Radiation Therapy (IMRT) allows for precise targeting of tumors, minimizing damage to surrounding healthy tissue, but it typically requires multiple sessions over several weeks. Stereotactic Body Radiation Therapy (SBRT), on the other hand, is a newer method that delivers high-dose radiation in fewer sessions, potentially reducing treatment time to just a few weeks. This means SBRT could make the treatment process quicker and more convenient for patients, maintaining effectiveness while possibly offering fewer side effects.

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

This trial will compare Stereotactic Body Radiation Therapy (SBRT) with Intensity-Modulated Radiation Therapy (IMRT) for treating prostate cancer. Research has shown that SBRT, which participants in this trial may receive, holds promise for treating prostate cancer. Studies have found that SBRT can prevent cancer recurrence for at least five years in about 83.6% of patients. It also alleviates symptoms with fewer severe side effects, though some patients may experience urinary issues within the first two years after treatment. Overall, SBRT is considered a safe and effective option for many prostate cancer cases.

In contrast, IMRT, another treatment option in this trial, is a well-established method for prostate cancer. It precisely targets tumors to protect healthy tissue while effectively shrinking the cancer. This method is safe and effective, with a long history of use. Both SBRT and IMRT effectively treat prostate cancer, but SBRT might work faster with fewer treatment sessions.12467

Who Is on the Research Team?

RJ

Rodney J Ellis

Principal Investigator

NRG Oncology

Are You a Good Fit for This Trial?

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
See 10 more

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.
See 6 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (SBRT)Experimental Treatment3 Interventions
Group II: Arm I (IMRT)Active Control3 Interventions

Find a Clinic Near You

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+

Published Research Related to This Trial

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.
Propensity score matched comparison of SBRT versus IMRT for the treatment of localized prostate cancer.Oliai, C., Bernetich, M., Brady, L., et al.[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.
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]
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.
[Stereotactic body radiation therapy versus conventional intensity-modulated radiation therapy for the treatment of prostate cancer].Gao, QN.[2022]

Citations

Five-year outcomes of stereotactic body radiation therapy ...Overall, SBRT may offer a higher 5-year bPFS rate of 83.6% and effective symptom relief without severe adverse effects. Additionally, no grade 4 or above ...
SBRT Proves Effective for Some Prostate Cancers - NCITrial participants who were randomly assigned to receive SBRT had a higher risk of developing some urinary problems over the first 2 years after ...
Long-Term Outcomes of Stereotactic Body Radiotherapy ...Despite advancements in prostate cancer treatment, local recurrence remains among the most common patterns of failure.
The effectiveness and safety of stereotactic body ...The results show minor, non-significant differences in survival rates compared to conventional fractionation, a type of external radiation, after two and five ...
Long-term treatment outcomes from the International Multi ...Conclusions: The safety and efficacy profile of SBRT for high-risk prostate cancer remains favorable at long-term follow-up. ADT of medium ...
Safety evaluation of stereotactic body radiation therapy ...Ultimately, 84% of patients completed all 6 cycles of 177Lu-PSMA-617 (range 4-6). The median follow-up time was 19.1 months (IQR 15.5-22.4) ...
Current State of Stereotactic Body Radiation Therapy for ...A small case series suggested that SBRT is safe and effective for upper tract urothelial carcinoma, although no high quality prospective evidence is available ...
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