Prostate SBRT for Prostate Cancer

Overseen By Deborah E Citrin, M.D.

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: National Cancer Institute (NCI)

Must not be taking: Investigational agents, Protease inhibitors

Disqualifiers: Metastatic disease, Anticoagulation therapy, others

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

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of focused radiation therapy called stereotactic body radiation therapy (SBRT) for prostate cancer. The researchers aim to determine the highest safe dose and identify any side effects. It targets men whose prostate cancer has returned in the same area after previous radiation treatment. Participants will receive five radiation treatments over two weeks. Men with recurrent prostate cancer that has not spread far are suitable candidates. Additionally, the trial uses 18F-DCFPyL, an imaging agent for PET/CT scans, to help visualize prostate cancer. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are on certain investigational drugs or need chronic anticoagulation therapy, except for low-dose aspirin.

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 that returns after initial radiation. Studies have found that SBRT can effectively target recurrent prostate cancer in the same area. However, some patients may experience urinary problems within the first two years after treatment.

For prostate radiation with an extra focus on the tumor, research confirms its safety, with side effects similar to those of regular radiation treatments. Most patients tolerate these treatments well, though some may experience urinary or bowel issues.

Overall, SBRT is considered a safe option for many patients. However, like any treatment, side effects can occur, and each person’s experience may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these prostate cancer treatments because they offer a targeted approach to tackling recurrent cancer with precision. Unlike traditional treatments that may involve extensive radiation to the entire prostate, these methods use stereotactic body radiation therapy (SBRT) to focus high doses specifically on cancerous areas. This precision helps spare healthy tissue, potentially reducing side effects. Additionally, some treatment arms combine this targeted radiation with a reduced dose to the whole prostate, which may enhance effectiveness while minimizing harm. This approach could lead to better outcomes for patients with recurrent prostate cancer, offering hope for improved quality of life and treatment success.

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

Research has shown that stereotactic body radiation therapy (SBRT) effectively treats prostate cancer, particularly when cancer returns to previously treated areas. In this trial, participants will join different treatment arms. One arm involves tumor irradiation alone, while another includes both prostate and tumor irradiation. Studies have found that using SBRT for prostate cancer does not increase the risk of recurrence. For patients who have already received radiation, SBRT as a second treatment is both safe and effective. When treatment targets the tumor directly, it can lead to high survival rates without cancer returning for several years. Overall, SBRT is a promising option for managing recurrent prostate cancer. ^{2 3 4 5 6}

Who Is on the Research Team?

Deborah Citrin, MD

Principal Investigator

National Cancer Institute (NCI)

Are You a Good Fit for This Trial?

This trial is for men over 18 with recurrent prostate cancer after radiation, no distant metastatic disease, and an ECOG performance status of ≤2. They must understand the study and consent to participate. Exclusions include HIV patients on certain treatments, liver issues, high PSA without clear scans, prior prostatectomy, severe medical or psychiatric conditions affecting the study outcome.

Inclusion Criteria

I can take care of myself but might not be able to do heavy physical work.

My prostate cancer came back after radiation treatment.

My PSA levels rose by at least 2 ng/dL after radiation therapy.

Exclusion Criteria

Other medical conditions deemed by the Principal Investigator (or associates) to make the subject unsafe or ineligible for protocol procedures

My cancer markers went up within a year after finishing radiotherapy.

My PSA level is 20 ng/dL or higher, and I may not have had a specific scan.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Radiation Treatment

Participants receive stereotactic body radiation therapy (SBRT) with 5 treatments over 2 weeks

2 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including repeat imaging and quality of life assessments

2 years

Routine visits until two years after treatment

What Are the Treatments Tested in This Trial?

Interventions

• 18F-DCFPyL
• Prostate radiation + tumor boost irradiation
• Prostate + tumor irradiation
• Tumor Irradiation

Trial Overview The trial tests SBRT's maximum tolerated dose in treating locally recurrent prostate cancer post-radiation. It involves a PET/CT scan using 18F-DCFPyL injection and MRI scans for planning treatment. Participants undergo five SBRT sessions over two weeks with follow-ups including physical exams and questionnaires.

How Is the Trial Designed?

Group I: Cohort 2, Level 2, Arm 2 - Prostate and Tumor Irradiation Experimental Treatment 3 Interventions

Arm 2: Prostate and tumor irradiation Arm 2 - 30 gray (Gy) planning target volume (PTV) to Prostate and 42.5 Gy to Tumor PTV Stereotactic body radiation therapy (SBRT) will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy; and a reduced dose will be delivered to the entire prostate. Brachytherapy: Participants with locally recurrent prostate cancer after treatment with brachytherapy +/- external beam radiation therapy (EBRT). These participants must have had brachytherapy as part of their treatment.

Group II: Cohort 2, Level 1, Arm 2 - Prostate and Tumor Irradiation Experimental Treatment 3 Interventions

Arm 2: Prostate and tumor irradiation Cohort 2, Level 1, Arm 2 - 30 gray (Gy) PTV to Prostate and 40 Gy to Tumor planning target volume (PTV) Stereotactic body radiation therapy (SBRT) will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy; and a reduced dose will be delivered to the entire prostate. Brachytherapy: Participants with locally recurrent prostate cancer after treatment with brachytherapy +/- external beam radiation therapy (EBRT). These participants must have had brachytherapy as part of their treatment.

Group III: Cohort 1, Level 2, Arm 1 - Tumor Irradiation Experimental Treatment 2 Interventions

Arm 1: Tumor irradiation. Cohort 1, Level 2, Arm 1 - 42.5 gray (Gy) to Tumor planning target volume (PTV) Stereotactic body radiation therapy (SBRT) will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy; and a reduced dose will be delivered to the entire prostate. External beam radiation therapy (EBRT): Participants with locally recurrent prostate cancer after treatment with EBRT. These participants cannot have had permanent brachytherapy as part of their treatment.

Group IV: Cohort 1, Level 1, Arm 1: Tumor Irradiation Experimental Treatment 2 Interventions

Arm 1: Tumor irradiation. Cohort 1, Level 1, Arm 1 - 40 gray (Gy) to Tumor planning target volume (PTV) Stereotactic body radiation therapy (SBRT) will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy. External beam radiation therapy (EBRT): Participants with locally recurrent prostate cancer after treatment with EBRT. These participants cannot have had permanent brachytherapy as part of their treatment.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa2214122

Fifteen-Year Outcomes after Monitoring, Surgery, or ... Primary Outcome​​ After median follow-up of 15 years, 45 patients (2.7%) had died of prostate cancer: 17 (3.1%) in the active-monitoring group, ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2405630824000831

Re-irradiation to the prostate using stereotactic body ... Conclusions. SBRT in the re-irradiation of radiorecurrent prostate cancer is safe and effective. Further prospective data are warranted.

3. cancer.gov cancer.gov/news-events/cancer-currents-blog/2024/prostate-cancer-sbrt-effective-safe

SBRT Proves Effective for Some Prostate Cancers - NCI Men who received the shortened treatment, called stereotactic body radiotherapy (SBRT), did not have a higher risk of cancer recurrence over the ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7475640/

Comparative effectiveness of surgery and radiotherapy for ... In the radiotherapy group, there were 20 deaths due to prostate cancer (0.8%), compared to 163 patients (6.8%) who died of other causes. The 5-year CSS was 99.8 ...

5. uclahealth.org uclahealth.org/news/release/study-confirms-safety-and-efficacy-higher-dose-per-day

Study confirms safety and efficacy of higher-dose-per-day ... Patients who received higher dose-escalated MHFRT did not improve cancer control when compared to those receiving standard doses, with five-year ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10741753/

Evaluation of Recurrent Disease after Radiation Therapy ... This review provides a comprehensive overview of the evaluation of patients with recurrent prostate cancer following radiation therapy.