SBRT for Prostate Cancer
Recruiting in Palo Alto (17 mi)
+7 other locations
Overseen byMichael Zelefsky, MD
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Memorial Sloan Kettering Cancer Center
Disqualifiers: Metastases, Lymph node involvement, Prior treatment, Active malignancy, Crohn's, others
No Placebo Group
Prior Safety Data
Approved in 4 Jurisdictions
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.
12345Is 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.
56789How 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.
24101112Eligibility 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
+5 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Patients with low-intermediate risk Decipher scoresExperimental Treatment1 Intervention
Will receive ultrahypofractionated EBRT to the prostate and seminal vesicles (40Gy in 5 fractions).
Group II: Patients with high risk Decipher scoresExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Memoral Sloan Kettering Monmouth (All Protocol Activities)Middletown, NJ
Memorial Sloan Kettering Westchester (All Protocol Activities)Harrison, NY
Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)Commack, NY
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New York, NY
More Trial Locations
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Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
References
Prostate Stereotactic Body Radiation Therapy With a Focal Simultaneous Integrated Boost: 5-Year Toxicity and Biochemical Recurrence Results From a Prospective Trial. [2023]Stereotactic body radiation therapy (SBRT) is increasingly used as a definitive treatment option for patients with prostate adenocarcinoma. The aim of this study was to assess the late toxicity, patient-reported quality of life outcomes, and biochemical recurrence rates after prostate SBRT with simultaneous integrated boost (SIB) targeting lesions defined by magnetic resonance imaging (MRI).
Stereotactic Body Radiotherapy for Prostate Cancer: Where, When, and Who? A Bibliometric Analysis. [2023]To provide an overview of the achievements and future research with stereotactic body radiotherapy (SBRT) in prostate cancer.
Stereotactic Body Radiation Therapy for Prostate Cancer: What is the Appropriate Patient-Reported Outcome for Clinical Trial Design? [2020]Stereotactic body radiation therapy (SBRT) is increasingly utilized as primary treatment for clinically localized prostate cancer. Consensus regarding the appropriate patient-reported outcome (PRO) endpoints for clinical trials evaluating radiation modalities for early stage prostate cancer is lacking. To aid in clinical trial design, this study presents PROs over a 36-month period following SBRT for clinically localized prostate cancer.
Stereotactic body radiation therapy (SBRT) for clinically localized prostate cancer: the Georgetown University experience. [2022]Stereotactic body radiation therapy (SBRT) delivers fewer high-dose fractions of radiation which may be radiobiologically favorable to conventional low-dose fractions commonly used for prostate cancer radiotherapy. We report our early experience using SBRT for localized prostate cancer.
Propensity score matched comparison of SBRT versus IMRT for the treatment of localized prostate cancer. [2022]Stereotactic body radiation therapy (SBRT) is an attractive option for prostate cancer due to its short treatment duration and cost. In this report, we compare the efficacy and toxicity outcomes of prostate cancer patients treated with SBRT to those who received intensity-modulated radiation therapy (IMRT).
Safety and Efficacy of Ultra-hypofractionation in Node-positive Prostate Cancer. [2021]The safety and efficacy of stereotactic body radiotherapy (SBRT) in localised prostate cancer are now established through phase III randomised trials. Its utility in node-positive prostate cancer is restricted due to a lack of controlled studies specifically addressing this subgroup. Herein we report the safety and efficacy of SBRT in this subgroup.
Prospective validation of stringent dose constraints for prostatic stereotactic radiation monotherapy: results of a single-arm phase II toxicity-oriented trial. [2022]There are no safety-focused trials on stereotactic body radiotherapy (SBRT) for localized prostate cancer. This prospective 3‑year phase II trial used binomial law to validate the safety and efficacy of SBRT with stringent organ at risk dose constraints that nevertheless permitted high planning target volume doses.
Patient-reported quality of life after stereotactic body radiotherapy (SBRT), intensity modulated radiotherapy (IMRT), and brachytherapy. [2022]Stereotactic body radiotherapy (SBRT) is being used for prostate cancer, but concerns persist about toxicity compared to other radiotherapy options.
Stereotactic body radiotherapy for localized prostate cancer: disease control and quality of life at 6 years. [2021]Stereotactic body radiotherapy (SBRT) may yield disease control for prostate cancer in a brief, hypofractionated treatment regimen without increasing treatment toxicity. Our report presents a 6-year update from 304 low- (n = 211), intermediate- (n = 81), and high-risk (n = 12) prostate cancer patients who received CyberKnife SBRT.
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]Stereotactic body radiotherapy (SBRT) is emerging as a treatment option in patients affected by oligorecurrent prostate cancer disease limited to lymph nodes, a subgroup of patients who would otherwise be treated only with androgen deprivation therapy (ADT).
Stereotactic Body Radiation Therapy for Prostate Cancer: Review of Experience of a Multicenter Phase I/II Dose-Escalation Study. [2022]Stereotactic body radiation therapy (SBRT) is an area of active investigation for treatment of prostate cancer. In our phase I dose-escalation study, maximum-tolerated dose (MTD) was not reached, and subsequently phase II study has been completed. The purpose of this article is to review our experiences of dose-escalated SBRT for localized prostate cancer.
The march toward single-fraction stereotactic body radiotherapy for localized prostate cancer-Quo Vadimus? [2023]Stereotactic body radiotherapy (SBRT) is an emerging treatment option for localized prostate cancer. There is increasing interest to reduce the number of fractions for prostate SBRT.