SBRT for Prostate Cancer

(PREPARE SBRT Trial)

Overseen By Pragya Yadav, Ph.D.

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Pelvic radiotherapy, Inflammatory bowel disease, others

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

Compensation: Varies

Number of Visits: 5

35 Participants Needed

Trial Summary

What is the purpose of this trial?

Men with prostate cancer with Gleason Score of 8 or greater or clinical/radiographic evidence of T3 disease will be considered for this trial.

Do I have to stop taking my current medications for the 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 data supports the effectiveness of the treatment SBRT for Prostate Cancer with dose escalation?

Research shows that using higher doses of stereotactic body radiotherapy (SBRT) for prostate cancer can lead to favorable outcomes, especially in patients with low- and intermediate-risk prostate cancer. ^{1 2 3 4 5}

Is SBRT safe for treating prostate cancer?

Research on stereotactic body radiation therapy (SBRT) for prostate cancer shows that while it can be effective, there are some risks of side effects. Studies have reported both short-term and long-term side effects, particularly affecting the urinary and digestive systems. ^{1 2 3 5 6}

How does SBRT for prostate cancer differ from other treatments?

SBRT (stereotactic body radiotherapy) for prostate cancer is unique because it uses high-dose radiation delivered in fewer sessions, known as dose escalation, which can mimic the effects of high-dose-rate brachytherapy without invasive procedures. This approach aims to improve tumor control while minimizing treatment time and potentially reducing side effects compared to traditional radiation therapy. ^{2 3 4 7 8}

Research Team

Silvia C. Formenti, M.D.

Principal Investigator

Weill Cornell Medicine - New York Presbyterian Hospital

Eligibility Criteria

The PREPARE SBRT trial is for men over 18 with high-risk prostate cancer, confirmed by a Gleason Score of 8+ or evidence of advanced disease (T3). Participants must be fit for surgery, have no prior pelvic radiotherapy, and not currently treated for inflammatory bowel disease. They need to have clear bone scans and MRI/CT scans without significant nodal involvement.

Inclusion Criteria

Patient can undergo an MRI.

I am mostly able to care for myself and carry out daily activities.

I am a man over 18 with confirmed prostate cancer.

Exclusion Criteria

I am currently being treated for inflammatory bowel disease.

I have had radiation therapy to my pelvic area before.

I do not want to have surgery to remove my prostate.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive stereotactic body radiotherapy (SBRT) with dose escalation and de-escalation to determine the recommended phase II dose

1 week

5 visits (in-person)

Surgery

Participants undergo radical prostatectomy after SBRT

1 month

Follow-up

Participants are monitored for acute toxicity and quality of life scores after treatment

3 months

Long-term follow-up

Participants' quality of life scores are collected over an extended period

5 years

Treatment Details

Interventions

• Dose escalation

Trial Overview This study tests the effects of increasing doses of stereotactic body radiotherapy (SBRT) before prostate removal surgery in men with aggressive prostate cancer. The goal is to see if higher radiation doses can better control the cancer when given before surgery.

Participant Groups

Group I: Single Arm Experimental Treatment 1 Intervention

This is a modified dose escalation and de-escalation study with an expansion of 3 or 6 pts to allow the recommended phase II dose (RP2D) be examined in a total of 9 pts. The dose limiting toxicity (DLT) is defined as Grade 3 or higher toxicity related to preoperative radiotherapy according to the Clavien-Dindo Classification. 3 radiation dose levels, 5 Gy, 6 Gy and 6.5Gy are considered. At the start of each dose level, 3 pts will be enrolled and treated for five days. If none of the 3 pts develop the DLT, the testing dose will escalate to the next level. If 1 of the 3 pts develops the DLT, the current dose will be tested in an additional 3 pts. If no additional pts develop the DLT, the dose will escalate.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Findings from Research

In a study of 24 patients with intermediate- and high-risk prostate cancer treated with dose-escalated stereotactic body radiation therapy (SBRT), the treatment showed a high 24-month prostate-specific antigen relapse-free survival rate of 95.8%.

The use of a high-dose avoidance zone (HDAZ) during SBRT resulted in low rates of acute and late genitourinary (GU) and gastrointestinal (GI) toxicities, with no severe (grade ≥3) toxicities reported, indicating a safe approach to dose escalation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-Escalated Stereotactic Body Radiation Therapy for Patients With Intermediate- and High-Risk Prostate Cancer: Initial Dosimetry Analysis and Patient Outcomes. Kotecha, R., Djemil, T., Tendulkar, RD., et al.[2022]

In a study of 551 low- and intermediate-risk prostate cancer patients treated with high-dose stereotactic body radiotherapy (SBRT), the treatment was well tolerated, with only 1.8% experiencing acute gastrointestinal toxicities and 10% experiencing acute genitourinary toxicities.

The 5-year cumulative incidence of prostate-specific antigen (PSA) failure was low at 2.1%, and 88% of patients who underwent biopsies after treatment showed no residual active disease, indicating effective tumor control with this treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Tolerance and Tumor Control Outcomes with High-dose Ultrahypofractionated Radiation Therapy for Prostate Cancer. Zelefsky, MJ., Pinitpatcharalert, A., Kollmeier, M., et al.[2021]

In a study of 103 patients undergoing stereotactic body radiation therapy (SBRT) for localized prostate cancer, 52% experienced a significant decline in bowel-related quality of life within one week, while 27.5% developed grade 2 or higher rectal toxicity.

Key dosimetric predictors of acute rectal toxicity were identified, specifically rectal D19% and V20Gy, which can help clinicians adjust treatment plans to reduce the risk of these side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric predictors of acute bowel toxicity after Stereotactic Body Radiotherapy (SBRT) in the definitive treatment of localized prostate cancer. Repka, MC., Carrasquilla, M., Paydar, I., et al.[2023]

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 79 prostate cancer patients treated with virtual HDR SBRT, the median PSA level dropped significantly from 5.6 ng/mL to 0.05 ng/mL after 5 years, indicating effective cancer control.

The treatment resulted in a high 5-year biochemical-relapse-free survival rate of 100% for low-risk and 92% for intermediate-risk patients, with manageable toxicity levels, including only 6% experiencing late grade 3 GU toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual HDR CyberKnife SBRT for Localized Prostatic Carcinoma: 5-Year Disease-Free Survival and Toxicity Observations. Fuller, DB., Naitoh, J., Mardirossian, G.[2023]

References

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

Dose-Escalated Stereotactic Body Radiation Therapy for Patients With Intermediate- and High-Risk Prostate Cancer: Initial Dosimetry Analysis and Patient Outcomes. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Early Tolerance and Tumor Control Outcomes with High-dose Ultrahypofractionated Radiation Therapy for Prostate Cancer. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Increased toxicities associated with dose escalation of stereotactic body radiation therapy in prostate cancer: results from a phase I/II study. [2023]

4. England pubmed.ncbi.nlm.nih.gov

A phase I dose-escalation trial of stereotactic body radiotherapy using 4 fractions for patients with localized prostate cancer. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Dosimetric predictors of acute bowel toxicity after Stereotactic Body Radiotherapy (SBRT) in the definitive treatment of localized prostate cancer. [2023]

6. China pubmed.ncbi.nlm.nih.gov

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

7. Switzerland pubmed.ncbi.nlm.nih.gov

Virtual HDR CyberKnife SBRT for Localized Prostatic Carcinoma: 5-Year Disease-Free Survival and Toxicity Observations. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Dosimetric Impact of Intrafraction Prostate Motion and Interfraction Anatomical Changes in Dose-Escalated Linac-Based SBRT. [2023]