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

Trial Summary

What is the purpose of this trial?

The researchers are doing this study to find out if stereotactic body radiation therapy (SBRT) without androgen deprivation therapy (ADT) is an effective treatment approach for people with unfavorable intermediate-risk prostate. The researchers will see whether SBRT can prevent participants' cancer from coming back and/or spreading to other parts of the body. In addition, they will look closely at how safe and effective it is to rely on Decipher test results for determining which patients would benefit from more extensive radiation treatments

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.

What data supports the effectiveness of the treatment Stereotactic Body Radiation Therapy (SBRT) for prostate cancer?

Research shows that SBRT is increasingly used for prostate cancer due to its short treatment duration and favorable outcomes. Studies report positive patient-reported quality of life and low rates of biochemical recurrence (return of cancer as indicated by blood tests) after treatment. ^{1 2 3 4 5}

Is SBRT safe for treating prostate cancer?

Research shows that SBRT (Stereotactic Body Radiation Therapy) is generally safe for treating localized prostate cancer, with studies indicating it does not increase treatment toxicity compared to other options. ^{5 6 7 8 9}

How is the treatment SBRT different from other treatments for prostate cancer?

SBRT (Stereotactic Body Radiation Therapy) is unique because it delivers high doses of radiation in fewer sessions compared to traditional radiation therapy, which may be more effective for treating localized prostate cancer. This approach is being actively researched and may offer a more convenient and potentially more effective option for patients. ^{2 4 10 11 12}

Research Team

Daniel Gorovets, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

Two or more of the following risk factors: Grade Group 2 or 3, cT2b-T2c, PSA 10 - 20 ng/mL, Able to undergo MRI for initial staging and MR based radiation planning, Sufficient biopsy tissue available for Decipher genomic testing, Prostate volume < 90cc, IPSS ≤ 20, Age ≥ 18, KPS ≥ or ECOG 0-2, Estimated life expectancy >5 years, Willing and able to provide written informed consent and Authorization for Use and Release of Health and Research Study Information (HIPAA authorization)

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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 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]

References

1. United States 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. [2023]

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

Stereotactic Body Radiotherapy for Prostate Cancer: Where, When, and Who? A Bibliometric Analysis. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiation Therapy for Prostate Cancer: What is the Appropriate Patient-Reported Outcome for Clinical Trial Design? [2020]

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

Stereotactic body radiation therapy (SBRT) for clinically localized prostate cancer: the Georgetown University experience. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Propensity score matched comparison of SBRT versus IMRT for the treatment of localized prostate cancer. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Ultra-hypofractionation in Node-positive Prostate Cancer. [2021]

7. Germany 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. [2022]

8. Ireland pubmed.ncbi.nlm.nih.gov

Patient-reported quality of life after stereotactic body radiotherapy (SBRT), intensity modulated radiotherapy (IMRT), and brachytherapy. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for localized prostate cancer: disease control and quality of life at 6 years. [2021]

10. Netherlands 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. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiation Therapy for Prostate Cancer: Review of Experience of a Multicenter Phase I/II Dose-Escalation Study. [2022]

12. Germany pubmed.ncbi.nlm.nih.gov

The march toward single-fraction stereotactic body radiotherapy for localized prostate cancer-Quo Vadimus? [2023]