Hypofractionated Radiation for Prostate Cancer

No longer recruiting at 1 trial location

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Must be taking: Androgen suppression

Must not be taking: Anticoagulants

Disqualifiers: Pelvic radiation, Chemotherapy, Rectal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 6}

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

My cancer is at a specific stage according to my pathology report.

My prostate cancer has high-risk features like spread or PSA levels between 0.2 and <2.0 after surgery.

My PSA level is below 2 ng/ml, measured after surgery.

Exclusion Criteria

I have received chemotherapy for prostate cancer before.

Major medical, addictive or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and/or interfere with follow-up. (Consent by legal authorized representative is not permitted for this study)

I have had radiation therapy to my pelvic area before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Androgen Suppression Therapy

Participants receive androgen suppression therapy subcutaneously or intramuscularly for up to 6 months before radiation therapy

6 months

Radiation Therapy

Participants undergo hypofractionated radiation therapy over 15-30 minutes every other day for 1-2 weeks, for 1-5 treatments

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Follow-up at 3 and 12 months, annually for 4 years, then every 2 years

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?

Group I: Group III (radiation therapy, androgen suppression therapy) Experimental Treatment 4 Interventions

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.

Group II: Group II (radiation therapy, androgen suppression therapy) Experimental Treatment 4 Interventions

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.

Group III: Group I (hypofractionated radiation therapy) Experimental Treatment 3 Interventions

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:

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

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12548115/

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 ...

2. uclahealth.org uclahealth.org/news/release/study-confirms-safety-and-efficacy-higher-dose-per-day

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 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1879850023001753

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 ...

4. redjournal.org redjournal.org/article/S0360-3016(24)02047-9/fulltext

A Meta-Analysis of Randomized Trials HFRT demonstrates a statistically significant improvement in BCPFS for patients with localized prostate cancer when compared to CFRT.

5. thelancet.com thelancet.com/journals/lanonc/article/PIIS1470-2045(25)00034-8/abstract

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.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12077468/

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.