SBRT for Prostate Cancer

Recruiting at 7 trial locations

Overseen By Daniel Gorovets, MD

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Metastases, Lymph node involvement, Prior treatment, Active malignancy, Crohn's, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

215 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if stereotactic body radiation therapy (SBRT), a targeted type of radiation therapy, can effectively treat prostate cancer without hormone therapy. Researchers seek to find out if SBRT can prevent cancer from returning or spreading. They also aim to assess whether a specific test, Decipher, can help identify patients who might require additional radiation. This trial may suit individuals diagnosed with unfavorable intermediate-risk prostate cancer who meet specific health criteria, such as particular biopsy results and the ability to undergo an MRI. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have had prior treatment for prostate cancer, including chemotherapy, surgery, or hormonal therapy, you may not be eligible to participate.

Is there any evidence suggesting that stereotactic body radiation therapy (SBRT) is likely to be safe for humans?

Research has shown that stereotactic body radiation therapy (SBRT) is generally safe for treating prostate cancer. One study found that SBRT yields good results with a low risk of serious side effects, such as severe harm to the body. Another study showed that 27% of men experienced urinary problems after SBRT, compared to 18% with standard radiation. However, these side effects are not considered severe.

Overall, prostate cancer patients tolerate SBRT well, with most side effects being manageable. This suggests it is a safe option for those considering this treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for prostate cancer?

Stereotactic Body Radiation Therapy (SBRT) is unique because it delivers targeted radiation to prostate cancer cells with high precision and in fewer sessions compared to traditional radiation therapy. Most standard treatments for prostate cancer, like conventional external beam radiation therapy, require multiple weeks of daily sessions. SBRT stands out by offering ultrahypofractionated radiation, which significantly reduces the number of treatments needed, potentially leading to fewer side effects and more convenience for patients. Researchers are particularly excited about its ability to precisely target higher-risk areas within the prostate, using detailed MRI scans, which may improve outcomes for patients with high-risk Decipher scores.

What evidence suggests that SBRT is an effective treatment for prostate cancer?

Research has shown that stereotactic body radiation therapy (SBRT) is a promising treatment for prostate cancer. SBRT effectively controls the disease, with some studies demonstrating high rates of long-term control in patients with low-risk prostate cancer. It serves as a standard treatment option for patients with various risk levels, from low to very high, who are considering radiation therapy. Although side effects, such as urinary issues, can occur, SBRT is generally considered safe and effective. In this trial, patients with low-intermediate risk Decipher scores will receive ultrahypofractionated EBRT to the prostate and seminal vesicles. Patients with high-risk Decipher scores will receive the same treatment, with an additional boost to the dominant intraprostatic lesion and hypofractionated pelvic EBRT. The Decipher test, used in this study, helps identify patients who might benefit from more intensive radiation, although its role in guiding treatment continues to be studied. ^{1 2 3 6 7}

Who Is on the Research Team?

Daniel Gorovets, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with unfavorable intermediate-risk prostate cancer who haven't had prior treatments like chemo, surgery, or hormonal therapy. They should have a life expectancy over 5 years and be able to undergo MRI scans. People can't join if they've had pelvic radiation before, evidence of cancer spread, recent TURP procedures, active second malignancy within the last 2 years (with some exceptions), or a history of Crohn's Disease or Ulcerative Colitis.

Inclusion Criteria

I was diagnosed with prostate cancer less than a year ago.

My prostate cancer is at an intermediate risk level, with a high Gleason Score or many positive biopsy results.

Exclusion Criteria

I have had prostate surgery within the last 6 months.

I have had treatment for prostate cancer, including chemotherapy, surgery, or hormone therapy.

Evidence of pelvic lymph node involvement as determined by MRI, PET, or CT imaging

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive ultrahypofractionated EBRT to the prostate and seminal vesicles (40Gy in 5 fractions). High-risk patients receive additional boost and pelvic EBRT.

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a focus on biochemical progression free survival.

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Stereotactic Body Radiation Therapy (SBRT)

Trial Overview The study tests if SBRT alone is effective in treating people with certain types of prostate cancer by preventing its return or spread without using ADT. It also evaluates the use of Decipher test results to decide on more extensive radiation treatments.

How Is the Trial Designed?

Group I: Patients with low-intermediate risk Decipher scores Experimental Treatment 1 Intervention

Will receive ultrahypofractionated EBRT to the prostate and seminal vesicles (40Gy in 5 fractions).

Group II: Patients with high risk Decipher scores Experimental Treatment 1 Intervention

Will receive ultrahypofractionated EBRT to the prostate and seminal vesicles (40Gy in 5 fractions) with a boost of up to 45Gy to the dominant intraprostatic lesion as identified on pretreatment MRI plus hypofractionated pelvic EBRT (25Gy in 5 fractions).

Stereotactic Body Radiation Therapy (SBRT) is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Stereotactic Body Radiation Therapy for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer
• Spinal tumors

Approved in European Union as Stereotactic Body Radiation Therapy for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer
• Spinal tumors

Approved in Canada as Stereotactic Body Radiation Therapy for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer
• Spinal tumors

Approved in Japan as Stereotactic Body Radiation Therapy for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer
• Spinal tumors

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

Stereotactic body radiotherapy (SBRT) shows a high local control rate of 98.1% in treating oligorecurrent prostate cancer limited to lymph nodes, based on a systematic review of 363 patients across nine studies with a median follow-up of 19.23 months.

The treatment demonstrated a low incidence of toxicity, with only 5.6% of patients experiencing grade ≥2 adverse effects, and no cases of grade 4 toxicity, suggesting that SBRT is a safe option for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring All Avenues for Radiotherapy in Oligorecurrent Prostate Cancer Disease Limited to Lymph Nodes: A Systematic Review of the Role of Stereotactic Body Radiotherapy. Ponti, E., Lancia, A., Ost, P., et al.[2022]

In a phase I/II study involving 91 patients with localized prostate cancer, stereotactic body radiation therapy (SBRT) demonstrated a remarkable prostate-specific antigen (PSA) control rate of 99% over a median follow-up of 42 months.

While the maximum-tolerated dose (MTD) was not reached, the study noted a concerning 10.6% incidence of high-grade rectal toxicity at the highest dose level of 50 Gray, prompting the need for dose constraints to reduce this risk in future trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiation Therapy for Prostate Cancer: Review of Experience of a Multicenter Phase I/II Dose-Escalation Study. Kim, DW., Straka, C., Cho, LC., et al.[2022]

Stereotactic body radiation therapy (SBRT) for localized prostate cancer showed a high two-year biochemical relapse-free survival rate of 99%, indicating its efficacy in controlling the disease.

The treatment was well tolerated, with low rates of gastrointestinal (1%) and genitourinary (31%) toxicities, and most patients who were sexually potent before treatment maintained their potency two years later.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy (SBRT) for clinically localized prostate cancer: the Georgetown University experience. Chen, LN., Suy, S., Uhm, S., et al.[2022]

Stereotactic body radiotherapy (SBRT) for localized prostate cancer shows promising results, with studies indicating that ultra-hypofractionated schedules (like 42.7 Gy in 7 fractions) are non-inferior to standard treatments in terms of 5-year biochemical recurrence-free survival and have similar tolerability.

Current evidence suggests that two-fraction SBRT may be the shortest effective treatment schedule, but caution is advised against single-fraction SBRT due to concerns about inferior efficacy, highlighting the need for ongoing trials to determine optimal fractionation schedules.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The march toward single-fraction stereotactic body radiotherapy for localized prostate cancer-Quo Vadimus? Ong, WL., Loblaw, A.[2023]

Between 2006 and 2020, there was a significant increase in publications and citations related to stereotactic body radiotherapy (SBRT) for prostate cancer, indicating growing interest and research in this treatment method.

The United States led the research output in this field, with a focus on SBRT applications in oligometastatic disease, reirradiation, and salvage therapy, highlighting key areas for future investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiotherapy for Prostate Cancer: Where, When, and Who? A Bibliometric Analysis. Viani, GA., Gouveia, AG., Jacinto, AA., et al.[2023]

Stereotactic body radiotherapy (SBRT) is shown to be safe and effective for treating node-positive prostate cancer, with a median follow-up of 30 months revealing no severe gastrointestinal toxicities and manageable genitourinary side effects.

In a study of 60 patients, SBRT resulted in a 3-year overall survival rate of 89% and a biochemical failure-free survival rate of 77%, indicating promising long-term outcomes even in patients with advanced disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Ultra-hypofractionation in Node-positive Prostate Cancer. Telkhade, T., Murthy, V., Kanala, TS., et al.[2021]

In a prospective phase II trial involving 110 patients aged 70 and older with localized prostate cancer, stereotactic body radiotherapy (SBRT) demonstrated a severe toxicity rate of less than 5%, confirming its safety for this patient population.

The SBRT regimen resulted in a biochemical progression-free survival (bPFS) rate of 90% over a median follow-up of 36 months, indicating its efficacy in treating localized prostate cancer without negatively impacting patients' quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective validation of stringent dose constraints for prostatic stereotactic radiation monotherapy: results of a single-arm phase II toxicity-oriented trial. Nguyen, P., Harzée, L., Retif, P., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Propensity score matched comparison of SBRT versus IMRT for the treatment of localized prostate cancer. Oliai, C., Bernetich, M., Brady, L., et al.[2022]

A study involving 803 patients analyzed the quality of life (QOL) impacts of SBRT, IMRT, and brachytherapy for localized prostate cancer, showing that all treatments resulted in good QOL two years post-treatment.

SBRT demonstrated similar outcomes to IMRT in urinary and sexual domains, but showed a significant improvement in bowel symptoms compared to brachytherapy, suggesting it may be a safer option with fewer side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported quality of life after stereotactic body radiotherapy (SBRT), intensity modulated radiotherapy (IMRT), and brachytherapy. Evans, JR., Zhao, S., Daignault, S., et al.[2022]

In a study of 304 prostate cancer patients treated with CyberKnife stereotactic body radiotherapy (SBRT), the treatment demonstrated excellent biochemical control rates, with 97% of low-risk, 90.7% of intermediate-risk, and 74.1% of high-risk patients remaining free from biochemical recurrence at 5 years.

The treatment was associated with low toxicity, as no patients experienced severe acute complications, and only a small percentage had Grade II urinary or rectal toxicities, indicating that SBRT is a safe and effective option for prostate cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for localized prostate cancer: disease control and quality of life at 6 years. Katz, AJ., Santoro, M., Diblasio, F., et al.[2021]

In a study of 26 patients with low- or intermediate-risk prostate adenocarcinoma, stereotactic body radiation therapy (SBRT) showed excellent biochemical control with no observed failures after a median follow-up of 59.5 months.

The treatment resulted in manageable late toxicity, with only 11.5% of patients experiencing significant genitourinary or gastrointestinal side effects, and patient-reported quality of life remained stable compared to pre-treatment levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate Stereotactic Body Radiation Therapy With a Focal Simultaneous Integrated Boost: 5-Year Toxicity and Biochemical Recurrence Results From a Prospective Trial. Maas, JA., Dobelbower, MC., Yang, ES., et al.[2023]

In a study of 174 hormone-naïve patients with localized prostate cancer treated with stereotactic body radiation therapy (SBRT), significant urinary symptoms were reported more frequently than bowel symptoms, with 51.6% of patients experiencing a clinically significant decline in urinary scores at 12 months.

The study indicates that while urinary and bowel symptoms initially increased after treatment, the proportion of patients reporting significant declines in these symptoms decreased from 12 to 36 months, suggesting potential late improvements in quality of life following SBRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiation Therapy for Prostate Cancer: What is the Appropriate Patient-Reported Outcome for Clinical Trial Design? Woo, JA., Chen, LN., Wang, H., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9954604/

Long-Term Outcomes of Stereotactic Body Radiotherapy ... Despite advancements in prostate cancer treatment, local recurrence remains among the most common patterns of failure.

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

SBRT Proves Effective for Some Prostate Cancers - NCI Over the 5 years of follow-up, a total of 27% of men in the SBRT group and 18% in the standard radiation therapy group reported urinary problems ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2773160X25000078

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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3022740/

Stereotactic body radiotherapy for low-risk prostate cancer This report demonstrates that SBRT can achieve high rates of durable disease control for patients with low-risk prostate cancer while resulting in low levels of ...

5. uclahealth.org uclahealth.org/departments/radonc/research-technologies/innovation-technology/external-beam-radiation-therapy-ebrt/stereotactic-body-radiation-therapy-sbrt/sbrt-prostate-cancer

SBRT for Prostate Cancer - Radiation Oncology SBRT is considered a standard of care option for any patient with low through very-high risk prostate cancer who is considering radiation therapy.

6. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2723641

Long-term Outcomes of Stereotactic Body Radiotherapy for ... This cohort study of pooled individual patient data assesses long-term outcomes after stereotactic body radiotherapy for low-risk and ...

7. ro-journal.biomedcentral.com ro-journal.biomedcentral.com/articles/10.1186/s13014-025-02598-8

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.