Stereotactic Body Radiotherapy for Prostate Cancer

Overseen By Linda Chan, MD

Age: Any Age

Sex: Male

Trial Phase: Academic

Sponsor: Linda Chan, MD

Disqualifiers: Prior prostatectomy, Prior radiotherapy, Implanted hardware, others

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

Compensation: Varies

Number of Visits: 5

Duration: 1-2 weeks

167 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for treating prostate cancer using TrueBeam stereotactic body radiotherapy. This technology delivers focused, high-intensity radiation to tumors, aiming to minimize damage to nearby healthy tissue. The study aims to determine if this approach not only treats the cancer but also improves patients' quality of life. Men diagnosed with prostate cancer who have not undergone surgeries or other radiation treatments to the prostate may be suitable candidates for this trial. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance future prostate cancer treatments.

Do I need to stop my current medications for this trial?

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.

What prior data suggests that this device is safe for treating prostate cancer?

Research has shown that TrueBeam stereotactic body radiotherapy (SBRT) is generally safe for treating localized prostate cancer. Studies indicate it rarely causes severe side effects, so most patients do not experience serious problems. For instance, one study found that most side effects were mild, with only a few patients experiencing more serious reactions.

Another study found that five years after treatment, 96% of men who received SBRT were cancer-free, suggesting the treatment is both effective and well-tolerated. Long-term evidence also supports its safety, with many patients remaining cancer-free for several years without major issues.

Overall, TrueBeam SBRT offers a good balance of safety and effectiveness for prostate cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about TrueBeam Stereotactic Body Radiotherapy for prostate cancer because it offers a cutting-edge approach to targeting tumors with precision. Unlike traditional radiation therapy, which can affect surrounding healthy tissues, TrueBeam delivers high doses of radiation directly to the tumor site with pinpoint accuracy. This method not only aims to reduce side effects but also shortens the treatment time significantly, providing patients with a more convenient and potentially more effective option.

What evidence suggests that TrueBeam stereotactic body radiotherapy is effective for prostate cancer?

Research has shown that TrueBeam stereotactic body radiotherapy (SBRT) effectively treats localized prostate cancer. Studies have found that higher doses of radiation in each session enhance the treatment's effectiveness. Patients generally face a low risk of serious side effects. This treatment targets high-intensity radiation on the tumor while safeguarding nearby healthy tissue. Overall, TrueBeam SBRT is considered a safe and promising option for controlling prostate cancer. ^{1 2 6 7 8}

Who Is on the Research Team?

Linda Chan, MD

Principal Investigator

Memorial Health Services

Are You a Good Fit for This Trial?

This trial is for men with prostate cancer stages I-IV without metastasis, and a prostate volume ≤ 100 cc. Participants should be in good physical condition (ECOG 0-1), have not had prior treatments like prostatectomy or cryotherapy, and must not have any implants that could interfere with treatment.

Inclusion Criteria

Clinical Stage I-IV, MX-M0 (AJCC 6th Edition)

M-stage determined by physical exam, CT, MRI, or Bone Scan. Bone scan not required for Monotherapy Risk Group patients unless clinical findings suggest possible osseous metastases. Bone Scan and contrast CT of the abdomen should be done patients in the Boost Risk Group patients.

Prostate volume: ≤ 100 cc (recommended not required)

Exclusion Criteria

You had surgery or cryotherapy to treat your prostate in the past.

You have previously received radiation therapy to the prostate or lower pelvis.

You have a medical device or implant that would make it difficult to plan or deliver treatment, according to the doctor's opinion.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TrueBeam stereotactic body radiosurgery, delivering high-dose radiation to the prostate in a non-invasive manner

1-2 weeks

5 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• TrueBeam Stereotactic Body Radiotherapy

Trial Overview The study tests TrueBeam stereotactic body radiosurgery on localized prostate cancer. It's a non-invasive method using high-intensity radiation beams to target the tumor while sparing healthy tissue, aiming to improve patients' quality of life.

How Is the Trial Designed?

Group I: Observation Experimental Treatment 1 Intervention

Observational study of patient efficacy and side effects

Who Is Running the Clinical Trial?

Linda Chan, MD

Lead Sponsor

Trials

1

Recruited

170+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04552509

TRUEBEAM Stereotactic Body Radiotherapy for Localized ... The purpose of this study is to determine the effects of TrueBeam stereotactic body radiosurgery in patients with prostate cancer.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11846345/

Stereotactic body radiotherapy (SBRT) as a treatment for ... SBRT for localized prostate cancer has favorable oncological outcomes with a low incidence of Grade 2 or higher toxicity.

3. varian.com varian.com/linac-based-sbrt-prostate-becoming-standard-option-ucla

Linac-based SBRT for Prostate: Becoming a Standard ... We now have evidence that prostate cancer has a very good response to a higher dose per treatment, and that these treatments are safe overall.”.

4. trial.medpath.com trial.medpath.com/clinical-trial/20f7b4c9e04f79f0/nct01581749-prospective-evaluation-truebeam-stx-radiosurgery-prostate-cancer

Evaluation of Truebeam for Low-Intermediate Risk Prostate ... The primary efficacy purpose is to compare 5 year biochemical disease free survival rates with TrueBeam to 5 year biochemical diseases free survival rates with ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6349624/

Prostate Stereotactic Body Radiation Therapy With a Focal ... Early studies found that a dose of 33.5 Gy in 5 fractions was associated with increased biochemical failure compared with dose-escalated conventionally ...

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/pros.24657

Long term update on toxicity and survival of a phase II trial ... The study found that after 5 years, 96% of the men who received SBRT were cancer-free, compared to 95% who received at least 20 doses of ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2452109422002494

Preliminary Analysis of a Phase II Trial of Stereotactic Body ... The median follow-up was 23 months (range, 10-37). SBRT was adjuvant in 8 (20%) patients, salvage in 28 (68%), and salvage with the presence of oligometastases ...

8. varian.com varian.com/why-varian/prostate-sbrt-valid-option-evidence-and-its-good-news

Is Prostate SBRT a Valid Option? The Evidence is In, ... Results showed a 7-year biochemical disease-free survival rate of 93.7 percent. They concluded that Prostate SBRT "has sufficient evidence to be ...