SBRT vs Hypofractionated Radiotherapy for Recurrent Prostate Cancer
Recruiting in Palo Alto (17 mi)
Overseen byCarlos E. Vargas, MD
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Mayo Clinic
Disqualifiers: Previous pelvic radiation, Prior chemotherapy, Active rectal diverticulitis, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?This phase III trial tests the side effects of stereotactic body radiation therapy (SBRT) compared to hypofractionated radiotherapy for treating patients with prostate adenocarcinoma that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to a limited number of sites (oligometastatic). SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumors cells and have fewer side effects. SBRT may work just as well as hypofractionated radiation therapy at treating patients with biochemically recurrent or oligometastatic prostate cancer, but with a shorter treatment time and possibly fewer side effects.
Will I have to stop taking my current medications?
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 vs Hypofractionated Radiotherapy for Recurrent Prostate Cancer?
Research shows that stereotactic body radiotherapy (SBRT), a form of hypofractionated treatment, has been effective in controlling prostate cancer with good outcomes over several years. Studies indicate that SBRT can manage the disease without increasing side effects, making it a promising option for prostate cancer treatment.
12345Is SBRT or Hypofractionated Radiotherapy safe for treating prostate cancer?
Research shows that SBRT and Hypofractionated Radiotherapy are generally safe for treating prostate cancer, with most patients experiencing mild to moderate side effects like urinary and gastrointestinal issues, which typically return to normal within six months.
24678How is the treatment SBRT different from other treatments for recurrent 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 can lead to improved patient outcomes and convenience. It uses advanced imaging to precisely target the cancer, potentially reducing damage to surrounding healthy tissue.
12569Eligibility Criteria
This trial is for men with prostate adenocarcinoma that has either returned after initial treatment or spread to a few other places. Participants should have undergone some prior therapy and be able to undergo imaging tests like PET scans, bone scans, and MRIs.Inclusion Criteria
My prostate cancer has spread to no more than 5 places.
My prostate cancer was confirmed through a tissue examination.
I can care for myself and am up and about more than 50% of my waking hours.
+6 more
Exclusion Criteria
Major medical, addictive, or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and/or interfere with follow-up. (Consent by legal authorized representative is not permitted for this study)
I have had radiation therapy to my pelvic area before.
I have had chemotherapy for prostate cancer before.
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Treatment
Participants undergo either SBRT over 1-2 weeks or hypofractionated radiation therapy over 4-6 weeks
1-6 weeks
5 visits (SBRT) or 20 visits (hypofractionated)
Follow-up
Participants are monitored for safety and effectiveness after treatment
5 years
Follow-up at 3 months, 12 months, annually until year 5, then every other year
Participant Groups
The study compares two radiation therapies: SBRT, which delivers precise doses over several days aiming to minimize damage to healthy tissue; versus hypofractionated radiotherapy, which gives higher doses in a shorter time frame potentially killing more tumor cells.
2Treatment groups
Experimental Treatment
Group I: Group II (Hypofractionated radiation therapy)Experimental Treatment7 Interventions
Patients undergo hypofractionated radiation therapy over 15-20 minutes once per day for a total of 20 treatments over 4-6 weeks in the absence of disease progression or unacceptable toxicity. Patients may receive androgen deprivation therapy for up to 18 months, as clinically indicated. Patients undergo bone scan and PET at screening and treatment failure, and undergo MRI and blood sample collection throughout the study.
Group II: Group I (SBRT)Experimental Treatment7 Interventions
Patients undergo SBRT over 15-20 minutes every other day for a total of 5 treatments over 1-2 weeks in the absence of disease progression or unacceptable toxicity. Patients may receive androgen deprivation therapy for up to 18 months, as clinically indicated. Patients undergo bone scan and PET at screening and treatment failure, and undergo MRI and blood sample collection throughout the study.
Hypofractionated Radiation Therapy is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Hypofractionated Radiotherapy for:
- Soft tissue sarcoma
- Extremity soft tissue sarcoma
🇪🇺 Approved in European Union as Hypofractionated Radiotherapy for:
- Soft tissue sarcoma
- Extremity soft tissue sarcoma
🇨🇦 Approved in Canada as Hypofractionated Radiotherapy for:
- Soft tissue sarcoma
- Extremity soft tissue sarcoma
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mayo Clinic in ArizonaScottsdale, AZ
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Who Is Running the Clinical Trial?
Mayo ClinicLead Sponsor
References
Stereotactic body radiotherapy for low-risk prostate cancer: five-year outcomes. [2022]Hypofractionated, stereotactic body radiotherapy (SBRT) is an emerging treatment approach for prostate cancer. We present the outcomes for low-risk prostate cancer patients with a median follow-up of 5 years after SBRT.
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.
The early result of whole pelvic radiotherapy and stereotactic body radiotherapy boost for high-risk localized prostate cancer. [2020]The rationale for hypofractionated radiotherapy in the treatment of prostate cancer is based on the modern understanding of radiobiology and advances in stereotactic body radiotherapy (SBRT) techniques. Whole-pelvis irradiation combined with SBRT boost for high-risk prostate cancer might escalate biologically effective dose without increasing toxicity. Here, we report our 4-year results of SBRT boost for high-risk localized prostate cancer.
Dosimetric and radiobiological comparison of Cyberknife and Tomotherapy in stereotactic body radiotherapy for localized prostate cancer. [2018]As recent studies have suggested relatively low α/β for prostate cancer, the interest in hypofractionated stereotactic body radiotherapy (SBRT) for prostate cancer is rising. The aim of this study is to compare dosimetric results of Cyberknife (CK) with Tomotherapy (HT) in SBRT for localized prostate cancer. Furthermore, the radiobiologic consequences of heterogeneous dose distribution are also analyzed.
Prostate stereotactic body radiotherapy—first UK experience. [2022]Stereotactic body radiotherapy (SBRT) combines image-guided radiotherapy with hypofractionation, both of which will probably result in improvements in patient outcomes in prostate cancer. Most clinical experience with this technique resides in North America. Here we present the first UK cohort to receive SBRT for prostate cancer.
Long-term outcomes from a prospective trial of stereotactic body radiotherapy for low-risk prostate cancer. [2022]Hypofractionated radiotherapy has an intrinsically different normal tissue and tumor radiobiology. The results of a prospective trial of stereotactic body radiotherapy (SBRT) for prostate cancer with long-term patient-reported toxicity and tumor control rates are presented.
Prostate Stereotactic Body Radiation Therapy: An Overview of Toxicity and Dose Response. [2022]Ultrahypofractionationed radiation therapy for prostate cancer is increasingly studied and adopted. The American Association of Physicists in Medicine Working Group on Biological Effects of Hypofractionated Radiotherapy therefore aimed to review studies examining toxicity and quality of life after stereotactic body radiation therapy (SBRT) for prostate cancer and model its effect.
A pilot study of intensity modulated radiation therapy with hypofractionated stereotactic body radiation therapy (SBRT) boost in the treatment of intermediate- to high-risk prostate cancer. [2022]Clinical data suggest that large radiation fractions are biologically superior to smaller fraction sizes in prostate cancer radiotherapy. The CyberKnife is an appealing delivery system for hypofractionated radiosurgery due to its ability to deliver highly conformal radiation and to track and adjust for prostate motion in real-time. We report our early experience using the CyberKnife to deliver a hypofractionated stereotactic body radiation therapy (SBRT) boost to patients with intermediate- to high-risk prostate cancer. Twenty-four patients were treated with hypofractionated SBRT and supplemental external radiation therapy plus or minus androgen deprivation therapy (ADT). Patients were treated with SBRT to a dose of 19.5 Gy in 3 fractions followed by intensity modulated radiation therapy (IMRT) to a dose of 50.4 Gy in 28 fractions. Quality of life data were collected with American Urological Association (AUA) symptom score and Expanded Prostate Cancer Index Composite (EPIC) questionnaires before and after treatment. PSA responses were monitored; acute urinary and rectal toxicities were assessed using Common Toxicity Criteria (CTC) v3. All 24 patients completed the planned treatment with an average follow-up of 9.3 months. For patients who did not receive ADT, the median pre-treatment PSA was 10.6 ng/ml and decreased in all patients to a median of 1.5 ng/ml by 6 months post-treatment. Acute effects associated with treatment included Grade 2 urinary and gastrointestinal toxicity but no patient experienced acute Grade 3 or greater toxicity. AUA and EPIC scores returned to baseline by six months post-treatment. Hypofractionated SBRT combined with IMRT offers radiobiological benefits of a large fraction boost for dose escalation and is a well tolerated treatment option for men with intermediate- to high-risk prostate cancer. Early results are encouraging with biochemical response and acceptable toxicity. These data provide a basis for the design of a phase II clinical trial.
Does CyberKnife improve dose distribution versus IMRT and VMAT on a linear accelerator in low-risk prostate cancer? [2023]Hypofractionated stereotactic body radiation therapy (SBRT) for prostate cancer (PCa) can be delivered with the robot-assisted CyberKnife (CK) system or on a linear accelerator using dynamic intensity-modulated radiotherapy (IMRT) or volumetric arc radiotherapy (VMAT). This retrospective study was performed to determine whether CK offers better dose distribution than IMRT and/or VMAT.