Shorter vs Usual Radiation Therapy for Prostate Cancer
Recruiting in Palo Alto (17 mi)
+280 other locations
Overseen ByKaren E Hoffman
Age: 18+
Sex: Male
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: NRG Oncology
Must be taking:Androgen deprivation therapy
Disqualifiers: Metastatic disease, Prior prostatectomy, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?This phase III trial compares stereotactic body radiation therapy (SBRT), (five treatments over two weeks using a higher dose per treatment) to usual radiation therapy (20 to 45 treatments over 4 to 9 weeks) for the treatment of high-risk prostate cancer. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period of time. This trial is evaluating if shorter duration radiation prevents cancer from coming back as well as the usual radiation treatment.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that patients taking 5-alpha reductase inhibitors like finasteride or dutasteride are eligible, so you may be able to continue those.
What data supports the effectiveness of the treatment External Beam Radiation Therapy (EBRT) and Stereotactic Body Radiation Therapy (SBRT) for prostate cancer?
Research shows that External Beam Radiation Therapy (EBRT) has been effective in treating prostate cancer for over 30 years, improving survival and reducing cancer progression. Additionally, Stereotactic Body Radiation Therapy (SBRT) using the CyberKnife system has shown promising results in treating low- to high-risk prostate cancer, indicating its potential effectiveness.
12345Is shorter radiation therapy for prostate cancer safe?
Research shows that shorter radiation therapy using CyberKnife for prostate cancer generally has lower rates of acute side effects compared to conventional radiation. Most patients experience mild to moderate side effects, with fewer severe reactions.
14678How is the treatment of shorter vs usual radiation therapy for prostate cancer different from other treatments?
This treatment uses a shorter course of radiation therapy, specifically Stereotactic Body Radiation Therapy (SBRT), which delivers high doses of radiation in fewer sessions compared to traditional methods. This approach can be more convenient and may reduce the overall treatment time while maintaining effectiveness.
234910Eligibility Criteria
This trial is for men with high-risk prostate cancer confirmed by tests, a PSA level over 20 ng/mL, Gleason Score of 8-10, and certain conditions on imaging. Participants must have a prostate size under 100 cc without evidence of distant metastases. Men should be at least 18 years old with an ECOG Performance Status of 0-2 and no prior radiation in the same area.Inclusion Criteria
My prostate gland is smaller than 100 cc before starting hormone therapy.
I can take care of myself and am up and about more than half of my waking hours.
My prostate cancer diagnosis was confirmed through lab tests.
My cancer has not spread beyond my pelvic nodes according to scans.
My pelvic lymph nodes are enlarged, measuring at least 1.0 cm.
My cancer is classified as cT3a-T3b, not cT4, based on exams or imaging.
My prostate cancer is aggressive (Gleason Score 8-10).
I haven't had radiation in the area where my current cancer is.
I am 18 years old or older.
Participant Groups
The study compares two types of radiation therapy: SBRT (five treatments over two weeks) versus usual radiation (20 to 45 treatments over four to nine weeks). It aims to see if the shorter SBRT prevents cancer return as effectively as the longer usual treatment.
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (SBRT)Experimental Treatment5 Interventions
Patients undergo SBRT for a total of 5 treatments over 2 weeks. Patients also undergo CT and/or MRI on study.
Group II: Arm II (EBRT)Active Control5 Interventions
Patients undergo EBRT for 20 to 45 treatments over 4 to 9 weeks. Patients also undergo CT and/or MRI on study.
External Beam Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
🇪🇺 Approved in European Union as External Beam Radiation Therapy for:
- Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers
🇺🇸 Approved in United States as External Beam Radiation Therapy for:
- Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers
🇨🇦 Approved in Canada as External Beam Radiation Therapy for:
- Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers
🇯🇵 Approved in Japan as External Beam Radiation Therapy for:
- Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers
🇨🇳 Approved in China as External Beam Radiation Therapy for:
- Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers
🇨🇭 Approved in Switzerland as External Beam Radiation Therapy for:
- Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Ascension Saint Mary's HospitalRhinelander, WI
University of Alabama at Birmingham Cancer CenterBirmingham, AL
Lewis and Faye Manderson Cancer CenterTuscaloosa, AL
University of Arkansas for Medical SciencesLittle Rock, AR
More Trial Locations
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Who is running the clinical trial?
NRG OncologyLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Stereotactic body radiotherapy for prostate cancer: a preliminary report. [2022]We report the results of a retrospective study of stereotactic body radiotherapy (SBRT) using a Cyberknife for prostate cancer.
External-beam radiotherapy in the management of carcinoma of the prostate. [2017]External-beam radiotherapy (EBRT) has been used in the treatment of adenocarcinoma of the prostate gland for more than 30 years. Well-documented clinical series have demonstrated the effectiveness of EBRT in achieving both cause-specific survival and freedom from biochemical (prostate-specific antigen [PSA]) progression.
Single fraction radiotherapy versus multiple fraction radiotherapy for bone metastases in prostate cancer patients: comparative effectiveness. [2020]External beam radiotherapy (EBRT) is an effective treatment for symptomatic bone metastases from a variety of primary malignancies. Previous meta-analyses and systematic reviews have reported on the efficacy of EBRT on bone metastases from multiple primaries. This review is focused on the comparative effectiveness of single fraction radiotherapy versus multiple fraction radiotherapy for bone metastases in prostate cancer patients.
Stereotactic ablative radiotherapy with CyberKnife in the treatment of locally advanced prostate cancer: preliminary results. [2017]Recent clinical reports of stereotactic ablative radiotherapy (SABR) in the treatment of low-risk prostate cancer have been encouraging. Our study evaluates the efficacy and safety of SABR using the CyberKnife system for treating intermediate- to very-high-risk prostate cancer.
Hypofractionated stereotactic body radiotherapy in low- and intermediate-risk prostate carcinoma. [2022]Stereotactic body radiotherapy (SBRT) takes advantage of low α/β ratio of prostate cancer to deliver a large dose in few fractions. We examined clinical outcomes of SBRT using CyberKnife for the treatment of low- and intermediate-risk prostate cancer.
CyberKnife stereotactic radiotherapy as monotherapy for low- to intermediate-stage prostate cancer: early experience, feasibility, and tolerance. [2016]The CyberKnife (CK), a linear accelerator mounted on a robotic device, enables excellent dose conformation to the target and minimizes dose to surrounding normal tissue. It is a very suitable device for performing hypofractionated stereotactic body radiotherapy as monotherapy for low- to intermediate-risk prostate cancer patients. We report our early experience using this technique.
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.
Ultrahypofractionated CyberKnifeTM based stereotactic radiotherapy versus conventional radiotherapy in patients with prostate cancer - acute toxicity evaluation in two phase II prospective studies. [2019]Our purpose was to compare the acute toxicity of ultrahypofractionated CyberKnifeTM based stereotactic radiotherapy (SBRT Arm) and conventional radiotherapy (EBRT Arm) in prostate cancer patients. Two-hundred-sixteen men with prostate cancer were enrolled in our prospective studies. One-hundred and nine were irradiated using CyberKnife to total dose of 36,25 Gy in 5 fractions. One-hundred and seven were irradiated conventionally to total dose of 76 Gy in 38 fractions. Mean age of patients was 69. Acute genitourinary (GU) and gastrointestinal (GI) adverse-events were collected. The maximal acute toxicity EORTC/RTOG score was assumed. A total of 41%, 44%, 12% and 3% of patients presented grade 0, 1, 2 and 3 acute genitourinary toxicity in SBRT arm, respectively. A total of 21%, 33%, 43% and 3% of patients demonstrated acute grade 0, 1, 2 and 3 genitourinary toxicity in EBRT arm. A significant difference between number of patients with grade 2 GU toxicity was observed (p-0.000) and between patients without any toxicity (p-0.0017).A significant difference in frequency of acute GI toxicity between both groups was observed, too. 71% vs. 44% had no toxicity (p-0.0001), and 3% vs. 18% (p-0.0004) presented grade 2 GI toxicity in SBRT and EBRT arms respectively.The acute toxicity rates of fractionated stereotactic radiotherapy is lower compared to conventional irradiation.
Oncologic outcome of salvage high-intensity focused ultrasound (HIFU) in radiorecurrent prostate cancer. A systematic review. [2021]External Beam Radiation Therapy (EBRT) is one of the option available for the treatment of clinically localized prostate cancer. In patients with radiorecurrent localized prostate cancer, Androgen Deprivation Therapy (ADT) is one of the most common therapeutic strategies. However, in the last decades, other salvage treatment options have been investigated, such as brachytherapy, cryoablation and High Intensity Focused Ultrasound (Hifu).
Moderate versus extreme hypofractionated radiotherapy: a toxicity comparative analysis in low- and favorable intermediate-risk prostate cancer patients. [2021]External beam radiotherapy (EBRT) is an effective treatment option for low- and favorable intermediate-risk prostate cancer (PCa) and it is usually delivered in conventional fractionation or with moderate hypofractionation (hRT), with comparable results. In the last years, a new treatment approach with stereotactic body radiotherapy (SBRT) has shown promising results. The aim of the present study was to directly compare the toxicity and outcome between hRT and SBRT in low and favorable intermediate PCa patients.