Radiation Therapy for Prostate Cancer
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: M.D. Anderson Cancer Center
Must be taking: Androgen deprivation
Disqualifiers: Lupus, Scleroderma, Diabetes, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
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.
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, it mentions that patients may receive androgen deprivation therapy for up to 24 months, so you might need to continue or adjust this treatment.
What data supports the effectiveness of this treatment for prostate cancer?
Research shows that hypofractionated radiotherapy, including techniques like intensity-modulated radiotherapy (IMRT) and stereotactic body radiotherapy (SBRT), can effectively treat prostate cancer by delivering higher doses of radiation in fewer sessions, potentially improving outcomes without increasing side effects.
12345Is radiation therapy for prostate cancer safe?
Research shows that hypofractionated radiation therapy (a type of radiation treatment given in larger doses over fewer sessions) for prostate cancer is generally safe, though some studies note potential acute side effects like genitourinary (urinary system) and gastrointestinal (digestive system) issues.
16789How is hypofractionated radiation therapy different from other treatments for prostate cancer?
Hypofractionated radiation therapy for prostate cancer is unique because it uses higher doses of radiation in fewer sessions compared to traditional methods, potentially reducing treatment time while maintaining effectiveness. This approach, especially with techniques like stereotactic body radiotherapy (SBRT), can target the cancer more precisely, minimizing damage to surrounding healthy tissue and reducing side effects.
14101112Eligibility 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.
I have been on hormone therapy for prostate cancer for up to 24 months.
+5 more
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.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo either conventional radiation therapy daily over 7 weeks or hypofractionated radiation therapy over 4.5 weeks after standard of care surgery
4.5-7 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Up to 5 years
Follow-up at 3-6 months, then every 6-12 months
Participant Groups
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:
πΊπΈ Approved in United States as Hypofractionated Radiotherapy for:
- Soft tissue sarcoma
- Extremity soft tissue sarcoma
πͺπΊ Approved in European Union as Hypofractionated Radiotherapy for:
- Soft tissue sarcoma
- Extremity soft tissue sarcoma
π¨π¦ 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
Loading ...
Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
References
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.
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.
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.
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.
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).
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.
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.
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.
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.
[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.
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.
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.