Moderate vs Ultra-Hypofractionated Radiation for Prostate Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of Michigan Rogel Cancer Center
Must not be taking: Androgen deprivation therapy
Disqualifiers: Pelvic radiation, Crohn's, Ulcerative colitis, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial compares the quality of life of prostate cancer patients treated with a short-term, high-dose radiation therapy to those treated with the standard, longer-term radiation therapy. The new method aims to reduce the number of treatments, making it easier for patients to complete their treatment and potentially improve their quality of life. This newer radiotherapy method for prostate cancer aims to shorten the treatment duration and improve patient convenience.
Do I need to stop my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on androgen deprivation therapy, there are specific conditions regarding its initiation and type that may affect your eligibility.
What data supports the effectiveness of the treatment Moderate vs Ultra-Hypofractionated Radiation for Prostate Cancer?
Research shows that ultra-hypofractionated radiation therapy, including stereotactic body radiation therapy (SBRT), is increasingly studied and adopted for prostate cancer, with studies indicating it is feasible and well-tolerated. Moderate hypofractionation has been shown to be as effective as conventional fractionation, and ultra-hypofractionated therapy allows for shorter treatment courses, although it may increase short-term side effects.
12345Is ultra-hypofractionated radiation therapy safe for prostate cancer treatment?
Ultra-hypofractionated radiation therapy, including stereotactic body radiation therapy (SBRT) and stereotactic ablative radiotherapy (SABR), has been studied for prostate cancer and is generally well-tolerated with careful planning. However, it may increase acute toxicity (short-term side effects) compared to conventional methods, so it is important to consider this when evaluating its safety.
14567How does ultra-hypofractionated radiation therapy differ from other treatments for prostate cancer?
Ultra-hypofractionated radiation therapy for prostate cancer is unique because it delivers higher doses of radiation in fewer sessions, allowing for a shorter treatment period compared to conventional or moderately hypofractionated radiation. This approach has been shown to be non-inferior in terms of effectiveness and safety, although it may increase the risk of acute side effects.
12589Eligibility Criteria
Men aged 18+ who've had prostate cancer confirmed by tissue review after surgery, with a PSA level of at least 0.1 ng/mL. They should be able to start radiation therapy at least 6 months post-surgery and have a KPS score of 70 or above, indicating they can carry out daily activities. Participants must be capable of completing a quality-of-life survey and provide consent.Inclusion Criteria
I can provide tissue from my prostate surgery for review.
My pelvic lymph nodes are small or unclear on scans, and any suspicious areas outside the pelvis have been biopsied and are cancer-free.
It has been 6 months or more since my prostate surgery.
+4 more
Exclusion Criteria
I have a history of moderate to severe Crohn's disease or ulcerative colitis.
Any condition that in the opinion of the investigator would preclude participation in this study
I have had a narrowing of my bladder neck or urethra.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either moderately hypo-fractionated radiation therapy over 5-6 weeks or ultra-hypofractionated radiation therapy over 3-4 weeks
3-6 weeks
Follow-up
Participants are monitored for safety, effectiveness, and quality of life after treatment
60 months
Participant Groups
This study compares two types of radiation therapy for prostate cancer patients after surgery: ultra-hypofractionated (SBRT) versus moderately hypo-fractionated radiation. The main goal is to see which treatment leads to better self-reported quality of life two years later.
2Treatment groups
Experimental Treatment
Active Control
Group I: Ultra-Hypofractionated Radiation TherapyExperimental Treatment1 Intervention
5 fractions of ultra-hypofractionated radiation therapy with at least one day between each treatment over the course of no more than 3-4 weeks
Group II: Moderately Hypo-fractionated Radiation TherapyActive Control1 Intervention
20 fractions of moderately hypofractionated radiation therapy over no more than 5-6 weeks.
Moderately Hypo-fractionated Radiation Therapy is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as Moderately Hypo-fractionated Radiation Therapy for:
- Prostate cancer
🇺🇸 Approved in United States as Moderately Hypo-fractionated Radiation Therapy for:
- Prostate cancer
🇨🇦 Approved in Canada as Moderately Hypo-fractionated Radiation Therapy for:
- Prostate cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Michigan Rogel Cancer CenterAnn Arbor, MI
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Who Is Running the Clinical Trial?
University of Michigan Rogel Cancer CenterLead Sponsor
References
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.
Long-Term Outcomes of a Prospective Study on Highly Hypofractionated Intensity Modulated Radiation Therapy for Localized Prostate Cancer for 3 Weeks. [2023]Reports of radiation therapy for prostate cancer using dose fractions between moderate hypofractionation and ultrahypofractionation are limited. This pilot study involved the application of highly hypofractionated intensity modulated radiation therapy (IMRT) in 15 fractions for 3 weeks and the number of fractions was intermediate between the 2 previously mentioned dose fractions. The long-term outcomes are reported.
Hypofractionated Radiotherapy for Localized Prostate Cancer: When and for Whom? [2020]To summarize recent evidence concerning the use of moderately hypofractionated external beam radiotherapy, defined as 2.4-3.4 Gy per fraction, and ultrahypofractionated external beam radiotherapy (also known as stereotactic body radiotherapy [SBRT]), defined as at least 5 Gy per fraction, in men with localized prostate cancer.
Stereotactic Ablative Body Radiotherapy for Intermediate- or High-Risk Prostate Cancer. [2021]Stereotactic ablative radiotherapy (SABR) is a relatively novel form of high precision radiotherapy. For low- and intermediate risk patients, ultrahypofractionation (UHF - more than 5 Gy per day) has been compared to conventionally fractionated or moderately hypofractionated radiotherapy in two large randomized studies. A third smaller randomized study examined the question of the optimal frequency of treatments. The results of these studies will be reviewed. SABR for high risk prostate cancer has been shown to be feasible and is well tolerated with careful planning and setup techniques. However, there is currently insufficient data supporting its use for high-risk patients to offer SABR outside of a clinical trial. SABR costs less to the radiotherapydepartments and, the patient, as well as increasing system capacity. Therefore, it has the potential to be widely adopted in the next few years.
Intensity-modulated fractionated radiotherapy versus stereotactic body radiotherapy for prostate cancer (PACE-B): acute toxicity findings from an international, randomised, open-label, phase 3, non-inferiority trial. [2022]Localised prostate cancer is commonly treated with external-beam radiotherapy. Moderate hypofractionation has been shown to be non-inferior to conventional fractionation. Ultra-hypofractionated stereotactic body radiotherapy would allow shorter treatment courses but could increase acute toxicity compared with conventionally fractionated or moderately hypofractionated radiotherapy. We report the acute toxicity findings from a randomised trial of standard-of-care conventionally fractionated or moderately hypofractionated radiotherapy versus five-fraction stereotactic body radiotherapy for low-risk to intermediate-risk localised prostate cancer.
Tumor Control Probability Modeling and Systematic Review of the Literature of Stereotactic Body Radiation Therapy for Prostate Cancer. [2022]Dose escalation improves localized prostate cancer disease control, and moderately hypofractionated external beam radiation is noninferior to conventional fractionation. The evolving treatment approach of ultrahypofractionation with stereotactic body radiation therapy (SBRT) allows possible further biological dose escalation (biologically equivalent dose [BED]) and shortened treatment time.
Hypofractionated stereotactic body radiation therapy as monotherapy for intermediate-risk prostate cancer. [2021]Hypofractionated stereotactic body radiation therapy (SBRT) has been advanced as monotherapy for low-risk prostate cancer. We examined the dose distributions and early clinical outcomes using this modality for the treatment of intermediate-risk prostate cancer.
Ultra-hypofractionated versus conventionally fractionated radiotherapy for prostate cancer (HYPO-RT-PC): patient-reported quality-of-life outcomes of a randomised, controlled, non-inferiority, phase 3 trial. [2021]The HYPO-RT-PC trial compared conventionally fractionated radiotherapy with ultra-hypofractionated radiotherapy in patients with localised prostate cancer. Ultra-hypofractionation was non-inferior to conventional fractionation regarding 5-year failure-free survival and toxicity. We aimed to assess whether patient-reported quality of life (QOL) differs between conventional fractionation and ultra-hypofractionation up to 6 years after treatment in the HYPO-RT-PC trial.
Ultra-hypofractionated versus conventionally fractionated radiotherapy for prostate cancer: 5-year outcomes of the HYPO-RT-PC randomised, non-inferiority, phase 3 trial. [2019]Hypofractionated radiotherapy for prostate cancer has gained increased attention due to its proposed high radiation-fraction sensitivity. Recent reports from studies comparing moderately hypofractionated and conventionally fractionated radiotherapy support the clinical use of moderate hypofractionation. To date, there are no published randomised studies on ultra-hypofractionated radiotherapy. Here, we report the outcomes of the Scandinavian HYPO-RT-PC phase 3 trial with the aim to show non-inferiority of ultra-hypofractionation compared with conventional fractionation.