126 Participants NeededMy employer runs this trial

Radiation Therapy for Prostate Cancer

Recruiting at 6 trial locations
DG
HN
Overseen ByHimanshu Nagar, MD
Age: Any Age
Sex: Any
Trial Phase: Phase 2
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
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 explores the optimal use of radiation therapy for treating prostate cancer while managing side effects. It compares two treatments: one combines brachytherapy (a type of internal radiation) with SBRT (a focused radiation treatment), and the other uses SBRT alone. Men with non-metastatic prostate cancer, deemed high-risk by their doctors, may qualify for this trial. Participants must be suitable for both types of radiation treatments as determined by their doctors. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

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

Research has shown that stereotactic body radiation therapy (SBRT) is generally safe for treating prostate cancer. Studies indicate that serious side effects are rare, with fewer than 5% of patients experiencing severe issues. Over time, many patients treated with SBRT have not had their cancer return and remain healthy, though some may experience urinary problems a few years after treatment.

Brachytherapy, another type of radiation treatment where tiny radioactive seeds are placed inside or near the tumor, is also used for prostate cancer. Like SBRT, it is effective and usually well-tolerated by patients. Combining both treatments aims to increase effectiveness while keeping side effects low.

In summary, both SBRT and brachytherapy have demonstrated safety, with a low risk of severe side effects, making them promising options for those considering these treatments.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these prostate cancer treatments because they explore innovative uses of radiation therapy. Brachytherapy, or internal radiation, delivers radiation directly to the tumor, minimizing damage to surrounding healthy tissues. The combination of HDR Brachytherapy Boost with SBRT (stereotactic body radiation therapy) in Arm A is unique because it potentially offers a more targeted and intense treatment regimen compared to traditional methods, which often involve external beam radiation over several weeks. In Arm B, SBRT alone is being tested for its ability to deliver high doses of radiation in fewer sessions, which could mean a shorter treatment time with similar or improved outcomes. These approaches aim to enhance precision and effectiveness while reducing treatment duration and side effects.

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

Research has shown that SBRT, a type of precise radiation therapy, effectively treats prostate cancer. One important study found that 98.6% of men were cured after five years. After ten years, men who received SBRT maintained high survival rates and experienced few side effects. Another study found that about 95% of patients remained cancer-free after more than six years. In this trial, participants may receive SBRT alone, as in Arm B, or a combination of HDR Brachytherapy Boost and SBRT, as in Arm A. Overall, these findings suggest that SBRT is a safe and effective way to manage prostate cancer.23678

Who Is on the Research Team?

DG

Daniel Gorovets, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for people diagnosed with prostate cancer. Participants should be adults who are healthy enough to receive radiation therapy and do not have other serious health issues that would prevent them from completing treatment.

Inclusion Criteria

My doctor says I am suitable for both HDR brachytherapy and SBRT.
My prostate cancer is considered intermediate, high, or very high risk.
My prostate cancer has not spread to other parts of my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive radiation therapy, either HDR Brachytherapy Boost + SBRT or SBRT alone

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Brachytherapy
  • SBRT

Trial Overview

The study compares two types of radiation treatments for prostate cancer: brachytherapy (placing radioactive material inside the body) and SBRT (a precise, high-dose external beam). The goal is to find which method works best with fewer side effects.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Arm B: SBRT AloneExperimental Treatment1 Intervention
Group II: Arm A: HDR Brachytherapy Boost + SBRTActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Palette Life Sciences, Inc.

Industry Sponsor

Trials
1
Recruited
80+

Citations

10-yr Survival and Toxicity Outcomes of Stereotactic Body ...

A 10-yr study of men treated with stereotactic body radiotherapy for prostate cancer found the treatment to be safe and effective. Very few men ...

SBRT for prostate cancer: How it compares to other ...

Early research shows that it works as well as other radiation treatments. More research is needed to confirm that these results hold up over ...

Shorter radiation improves patient experience but not ...

88.6% of patients in the SBRT group were free from disease progression after three years, compared to 92.1% receiving longer courses of ...

SBRT Proves Effective for Some Prostate Cancers - NCI

After a median follow-up period of just over 6 years, about 95% of men in both treatment groups remained alive without a recurrence of their ...

SBRT Shows 98% Prostate Cancer Cure Rate

This groundbreaking study, the first trial to publish five-year results from SBRT treatment for prostate cancer, found a 98.6 percent cure rate ...

Comparison of outcomes and toxicities among radiation ...

Studies did not use patient-reported outcomes, through grade 3–4 toxicities were rare (<5%) among all modalities. There was limited evidence Almost

SBRT for Prostate Cancer - Radiation Oncology

SBRT is now supported by high level evidence as a safe and effective treatment. Since then, a large amount of data and evidence have amassed demonstrating the ...

Stereotactic body radiation therapy for prostate cancer—a ...

The 3-year actuarial FFBF was 100% for intermediate- and 89.8% for high-risk patients. For a complete list of studies describing the outcomes of SBRT boost ...