Trial Summary
What is the purpose of this trial?This phase III trial studies how well hypofractionated radiation therapy works compared to the conventional one in treating patients with prostate cancer. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.
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, you can continue androgen deprivation therapy if you are already on it.
Is Hypofractionated Radiation Therapy a promising treatment for prostate cancer?Yes, Hypofractionated Radiation Therapy is a promising treatment for prostate cancer. It allows for higher doses of radiation in fewer sessions, which can be as effective as traditional methods. This approach can improve patient outcomes, especially for certain groups, and is becoming a strong alternative to conventional treatments.134911
What data supports the idea that Radiation Therapy for Prostate Cancer is an effective treatment?The available research shows that Radiation Therapy for Prostate Cancer, including methods like hypofractionated radiotherapy and proton therapy, is effective. For example, one study reports that using a combination of whole-pelvis irradiation and stereotactic body radiotherapy (SBRT) boosts for high-risk prostate cancer can increase the treatment dose without adding more side effects. Another study highlights that moderately hypofractionated proton therapy is effective for localized prostate cancer, with positive outcomes reported over four years. These findings suggest that Radiation Therapy is a promising option for treating prostate cancer, offering benefits in terms of treatment effectiveness and patient outcomes.234810
What safety data is available for radiation therapy in prostate cancer treatment?The safety data for radiation therapy in prostate cancer treatment includes several studies on hypofractionated radiation therapy (HFRT). These studies indicate that HFRT is generally safe and effective for localized prostate cancer. However, acute toxicity, particularly genitourinary (GU) and gastrointestinal (GI) toxicity, is a concern, especially when combined with androgen suppression therapy. Different studies have evaluated the safety of various HFRT regimens, including those using intensity-modulated radiotherapy (IMRT) and helical tomotherapy (HT), with findings suggesting that while HFRT can improve treatment outcomes, acute toxicity may limit its feasibility. Overall, the safety profile of HFRT varies depending on the specific regimen and additional therapies used.456712
Eligibility Criteria
Men aged 18+ with prostate cancer, Gleason score 6-10, and stage T2-T3M0 can join. They may have up to 5 metastatic pelvic lymph nodes and must have had a radical prostatectomy. Eligible if they've received or will receive hormone therapy for up to 24 months but no prior radiation in the target area or severe co-morbidities like lupus, uncontrolled diabetes, recent heart issues, severe liver disease.Inclusion Criteria
I had cancer other than prostate, treated over a year ago, with no current signs of that cancer.
I have prostate cancer and had surgery to remove my prostate.
My cancer is at stage T2-T3M0 and may have up to 5 pelvic lymph nodes involved.
I am able to get out of my bed or chair and move around.
My prostate cancer has a Gleason score between 6 and 10.
I am a man aged 18 or older.
Exclusion Criteria
I have severe health issues or uncontrolled diabetes.
I have had radiation therapy to my prostate or nearby areas.
I have received chemotherapy before or after surgery to remove my prostate.
I haven't been hospitalized for heart issues like unstable angina or heart failure in the last 6 months.
I am on dialysis or have been advised to start dialysis.
I have a history of lupus, scleroderma, or CREST syndrome.
I do not have severe liver disease.
Treatment Details
The trial compares two types of radiation therapy for prostate cancer: conventional (standard doses over a longer period) versus hypofractionated (higher doses over a shorter period). It aims to see which is more effective at killing tumor cells with fewer side effects.
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (hypofractionated radiation therapy)Experimental Treatment3 Interventions
Patients undergo hypofractionated radiation therapy over 4.5 weeks after standard of care surgery.
Group II: Arm I (conventional radiation therapy)Active Control3 Interventions
Patients undergo conventional radiation therapy daily over 7 weeks after standard of care surgery.
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:
M D Anderson Cancer CenterHouston, TX
MD Anderson League CityLeague City, TX
MD Anderson in Sugar LandSugar Land, TX
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
References
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.
A phase II study of hypofractionated proton therapy for prostate cancer. [2022]Hypofractionated radiotherapy potentially offers therapeutic gain for prostate cancer. We investigated the feasibility of hypofractionated proton therapy (PT).
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.
Acute toxicity of hypofractionated intensity-modulated radiotherapy for prostate cancer. [2018]Dose-escalated hypofractionated radiotherapy (hfrt) using intensity-modulated radiotherapy (imrt), with inclusion of the pelvic lymph nodes (plns), plus androgen suppression therapy (ast) in high-risk prostate cancer patients should improve patient outcomes, but acute toxicity could limit its feasibility.
Moderate hypofractionation and simultaneous integrated boost by helical tomotherapy in prostate cancer: monoinstitutional report of acute tolerability assessment with different toxicity scales. [2018]Based on radiobiology evidence, hypofractionated radiotherapy has the potential of improving treatment outcome in prostate cancer patients. In this study, we evaluated the safety, in terms of acutetoxicity, of using moderate hypofractionated radiotherapy delivered with Helical Tomotherapy (HT) to treat prostate cancer patients.
4 Weeks Versus 5 Weeks of Hypofractionated High-dose Radiation Therapy as Primary Therapy for Prostate Cancer: Interim Safety Analysis of a Randomized Phase 3 Trial. [2022]Hypofractionated radiation therapy (HFRT) for localized prostate cancer is safe and effective. The question that remains is which hypofractionation schedule to implement. We compared 2 different HFRT regimens in the present study.
Acute Toxicity Profiles of Hypofractionated Adjuvant and Salvage Radiation Therapy After Radical Prostatectomy: Results of a Prospective Study. [2019]Hypofractionated radiation therapy (RT) is controversial after radical prostatectomy (RP). In this interim analysis, our prospective observational study assessed acute genitourinary (GU) and gastrointestinal (GI) toxicity after hypofractionated adjuvant and salvage RT, as delivered by helical tomotherapy (HT), in patients with prostate cancer.
Four-Year Outcomes From a Prospective Phase II Clinical Trial of Moderately Hypofractionated Proton Therapy for Localized Prostate Cancer. [2020]Moderately hypofractionated radiation therapy represents an effective treatment for localized prostate cancer (PC). Although large randomized trials have reported the efficacy of photon-based hypofractionated therapy, hypofractionated proton therapy (HFPT) has not been extensively studied. This study was performed to determine the clinical and patient-reported outcomes for patients with PC treated with HFPT.
[Moderate or extreme hypofractionation and localized prostate cancer: The times are changing]. [2019]There are many treatment options for localized prostate cancers, including active surveillance, brachytherapy, external beam radiotherapy, and radical prostatectomy. Quality of life remains a primary objective in the absence of superiority of one strategy over another in terms of specific survival with similar long-term biochemical control rates. Despite a significant decrease in digestive and urinary toxicities thanks to IMRT and IGRT, external radiotherapy remains a treatment that lasts approximately 2 months or 1.5 months, when combined with a brachytherapy boost. Given the specific radiosensitivity of this tumor, several randomized studies have shown that a hypofractionated scheme is not inferior in terms of biochemical control and toxicities, allowing to divide the number of fractions by a factor 2 to 8. Given that SBRT becomes a validated therapeutic option for a selected population of patients with localized prostate cancer, extreme hypofractionation is becoming a strong challenger of conventional external radiotherapy or brachytherapy.
Dosimetric benefits of daily treatment plan adaptation for prostate cancer stereotactic body radiotherapy. [2022]Hypofractionation is increasingly being applied in radiotherapy for prostate cancer, requiring higher accuracy of daily treatment deliveries than in conventional image-guided radiotherapy (IGRT). Different adaptive radiotherapy (ART) strategies were evaluated with regard to dosimetric benefits.
RADIOTHERAPY OF PROSTATE CANCER: PRIMARY RADIOTHERAPY AND RADIOTHERAPY IN DISEASE RELAPSE. [2022]Radiotherapy presents one of the essential modes of treatment in patients with prostate cancer at almost any stage of the disease. It can be delivered as external beam radiotherapy, as brachytherapy or two methods combined. Higher radiation doses are proven to be more effective than low doses and moderate hypofractionation with doses up to 3.4 Gy per fraction is proven equivalent to standard fractionation using 1.8- 2 Gy per fraction. Stereotactic body radiotherapy (SBRT) with doses from 3.4 to 7.25 Gy per fraction presents valuable option in certain subgroups of patients. In case of local regional disease relapse, radiotherapy is used in curative setting.
Radiation Therapy for Prostate Cancer Using HYpofractionation Directed by UltraSound (RAPHYDUS): A Brazilian Public Health Care System Study. [2022]This study evaluated the toxicity associated with a short course dose-escalated hypofractionated radiation therapy (HFRT) using image guided RT with or without androgen suppression therapy in patients with prostate cancer.