Hypofractionated Radiation for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new approach to radiation therapy for prostate cancer with high-risk features after surgery. The goal is to determine if higher doses of radiation over a shorter period can kill more cancer cells while reducing side effects. Participants will receive either hypofractionated radiation therapy alone or a combination of radiation and androgen suppression therapy, which lowers male hormone levels. Men who have had prostate cancer surgery and still exhibit certain high-risk factors, such as tumor spread or specific PSA levels, might be suitable for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in prostate cancer care.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on certain blood thinners like warfarin or heparin unless they can be stopped for treatment-related reasons.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that a shorter course of radiation therapy, known as hypofractionated radiation therapy, is generally safe for treating prostate cancer. Studies involving over 9,000 men found that this shorter treatment had side effects similar to the traditional, longer treatment. Importantly, these studies reported no severe side effects, indicating that patients generally tolerate this treatment well. Therefore, for those considering joining a trial with this treatment, the safety data from past research appears promising.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about hypofractionated radiation therapy for prostate cancer because it offers a potentially quicker and more convenient treatment option compared to traditional radiation therapy. Unlike standard radiation therapy, which often involves daily sessions over several weeks, hypofractionated radiation delivers higher doses of radiation in fewer sessions, typically over just 1-2 weeks. This method not only reduces the overall treatment time but may also increase patient comfort and adherence. Additionally, when combined with androgen suppression therapy, it might enhance treatment effectiveness by targeting cancer cells more aggressively.
What evidence suggests that hypofractionated radiation therapy could be effective for prostate cancer?
This trial will evaluate hypofractionated radiation therapy (HFRT) in different contexts. Studies have shown that HFRT can be as effective as traditional radiation in preventing prostate cancer recurrence. For patients with localized prostate cancer, HFRT has significantly extended the period during which cancer does not return, reducing the likelihood of recurrence. Research indicates that delivering higher doses of radiation over a shorter period does not worsen outcomes and may be as effective as traditional methods. Additionally, HFRT can reduce the number of doctor visits, offering more convenience for patients. Participants in this trial may receive HFRT alone or combined with androgen suppression therapy, depending on the treatment group.12346
Who Is on the Research Team?
Carlos E. Vargas, M.D.
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
Men with prostate cancer showing high-risk features after surgery can join this trial. They should have no history of chemotherapy for prostate cancer, heart issues in the last 6 months, or major illnesses that could affect participation. No prior pelvic radiation or long-term androgen suppression therapy is allowed.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Androgen Suppression Therapy
Participants receive androgen suppression therapy subcutaneously or intramuscularly for up to 6 months before radiation therapy
Radiation Therapy
Participants undergo hypofractionated radiation therapy over 15-30 minutes every other day for 1-2 weeks, for 1-5 treatments
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Hypofractionated Radiation Therapy
Trial Overview
The study tests if a shorter period of intense radiation therapy combined with hormone suppression can effectively treat prostate cancer post-surgery. It aims to see if this approach kills more tumor cells while causing fewer side effects.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Participants receive androgen suppression therapy as Group II for up to 18 months (at the discretion of the treating physician), then undergo hypofractionated radiation therapy over 15-30 minutes every other day over 1-2 weeks, for 1-5 treatments.
Beginning 8-10 weeks before radiation therapy, participants receive androgen suppression therapy SC or IM for up to 6 months (at the discretion of the treating physician). Participants then undergo hypofractionated radiation therapy as Group I.
Participants undergo hypofractionated radiation therapy over 15-30 minutes every other day over 2 weeks, for 5 treatments.
Hypofractionated Radiation Therapy is already approved in United States, European Union, Canada for the following indications:
- Soft tissue sarcoma
- Extremity soft tissue sarcoma
- Soft tissue sarcoma
- Extremity soft tissue sarcoma
- Soft tissue sarcoma
- Extremity soft tissue sarcoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
evidence from 9074 men in 13 randomized clinical trials
There was no statistically significant difference in relapse-free survival after five years of treatment between the HFRT and CFRT groups. In ...
Study confirms safety and efficacy of higher-dose-per-day ...
While dose-escalated MHFRT was expected to improve outcomes, the data showed no additional benefit in cancer control and a higher risk of ...
Long-Term Outcomes of a Prospective Study on Highly ...
In this study, the efficacy and safety of highly hypofractionated IMRT in 15 fractions were evaluated for low- to intermediate-risk prostate cancer. The 5- and ...
A Meta-Analysis of Randomized Trials
HFRT demonstrates a statistically significant improvement in BCPFS for patients with localized prostate cancer when compared to CFRT.
Hypofractionated radiotherapy for prostate cancer (HYDRA)
Hypofractionated radiotherapy for prostate cancer (HYDRA): an individual patient data meta-analysis of randomised trials in the MARCAP consortium.
Hypofractionated radiotherapy for localized prostate cancer
This trial aims to investigate the safety outcomes of HFRT in 15 fractions for treating patients with localized PCa.
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