Hypofractionated Radiation for Prostate Cancer

Overseen By Tina K Livingood

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Must not be taking: Investigational agents

Disqualifiers: Other malignancy, Prior prostatectomy, others

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

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 explores a new method to treat prostate cancer using hypofractionated radiation therapy, which involves fewer but higher doses of radiation. The main aim is to determine if this method causes additional urinary problems compared to standard treatments. It seeks men diagnosed with early-stage prostate cancer (T1-T2bN0M0) who have a prostate-specific antigen (PSA) level under 20 and no other active cancers. Participants must not have had prior prostate surgery or pelvic radiation and should be able to follow specific preparation procedures for the treatment. As an unphased trial, this study offers participants the opportunity to contribute to innovative research that could enhance future prostate cancer treatments.

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, androgen deprivation therapy is allowed if your doctor thinks it's necessary.

What prior data suggests that hypofractionated radiation is safe for prostate cancer treatment?

In a previous study, researchers found that hypofractionated radiation, which involves delivering higher doses of radiation in fewer sessions, is generally safe for prostate cancer patients. Patients who received this treatment experienced similar cancer control and side effects compared to those who underwent traditional radiation therapy. Another study showed that even with a higher dose per session, patients did not experience more severe side effects.

Long-term research supports these findings, indicating that this shorter radiation schedule is as safe as the longer, traditional one. Overall, studies suggest that patients tolerate hypofractionated radiation well, with side effects similar to conventional methods. Thus, individuals considering this treatment can expect a safety profile comparable to standard radiation therapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Hypofractionated radiation therapy is unique because it delivers higher doses of radiation over fewer sessions compared to the standard radiation therapy for prostate cancer. Traditional radiation treatments might require daily sessions over several weeks, but hypofractionated radiation aims to complete treatment in just two sessions. Researchers are excited about this approach as it could reduce the overall treatment time and improve patient convenience, while potentially maintaining or even enhancing effectiveness. This method could also minimize disruption to patients' daily lives, making it a promising option for those seeking efficient and effective care.

What evidence suggests that hypofractionated radiation is effective for prostate cancer?

Research shows that hypofractionated radiation therapy works well for prostate cancer. In this trial, all participants will receive this treatment. Studies have found that it can lead to high survival rates, with about 95.7% of patients surviving at least five years without cancer recurrence. A review of different studies also found that overall survival and other outcomes are similar to those of traditional radiation therapy. This treatment requires fewer sessions, making it more convenient for patients. Importantly, it is just as effective without causing more side effects like urinary or sexual problems. Overall, hypofractionated radiation therapy is a promising option for people with prostate cancer. ^{6 7 8 9 10}

Who Is on the Research Team?

Xinglei Shen

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

Men over 18 with early-stage prostate cancer (T1-T2bN0M0, GS6-7, PSA < 20) who have a life expectancy of more than 10 years and are in good physical condition (ECOG score 0-1). They must not have had prior treatments like prostatectomy or pelvic radiation, no active other cancers or certain diseases like inflammatory bowel disease. Prostate size should be less than 50 cc.

Inclusion Criteria

My prostate symptoms score is low, under 15, or under 10 if I'm on medication like tamsulosin.

I am allowed to receive hormone therapy for my condition.

I am fully active or can carry out light work.

Exclusion Criteria

I have had surgery to remove my prostate.

I have had radiation therapy to my pelvic area before.

Psychiatric illness/social situations that would limit compliance with study requirements

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Treatment

Participants receive 2 fraction SBRT radiation therapy to the prostate

1-2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

1 month post-RT, every 3 months for the first year, then every 6 months for the next 4 years

What Are the Treatments Tested in This Trial?

Interventions

• Hypofractionated Radiation

Trial Overview

The trial is testing ultra-hypofractionated radiation therapy to see if it increases urinary toxicity in men with prostate cancer. This involves giving higher doses of radiation in fewer sessions compared to traditional schedules.

How Is the Trial Designed?

Group I: Hypofrac Radiation Therapy Experimental Treatment 1 Intervention

All patients on this study will receive the same type of therapy, 2 treatment hypofractionated radiation therapy. Radiation treatment will start approximately 1-2 weeks after the simulation scan. Prior to each treatment, you will be asked to have a full bladder and empty rectum. You will be asked to take a liquid diet starting the afternoon prior to each treatment, and a laxative (such as Miralax) in the evening prior to each treatment. You will also be asked to take a Fleet's enema about 1 hours prior to the treatment time to ensure that the rectum is empty. To ensure full bladder, you will be asked to drink about 32 oz of water after the enema. This is the same procedure as above for the prep before the simulation scan. Each treatment should take about 10-20 minutes.

Hypofractionated Radiation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Hypofractionated Radiotherapy for:

• Endometrial cancer

Approved in European Union as Hypofractionated Radiotherapy for:

• Endometrial cancer
• Cervical cancer

Approved in Canada as Hypofractionated Radiotherapy for:

• Endometrial cancer

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Published Research Related to This Trial

In a study of 820 patients with localized prostate cancer, hypofractionated radiation therapy showed similar 5-year relapse-free survival rates compared to conventional radiation therapy, but it did not demonstrate noninferiority in terms of genitourinary and gastrointestinal quality of life.

While hypofractionation did not perform as well for urinary and gastrointestinal symptoms, it was found to be noninferior for other aspects of quality of life, such as symptoms related to androgen deprivation therapy and sexual function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moderate Hypofractionation in Intermediate- and High-Risk, Localized Prostate Cancer: Health-Related Quality of Life From the Randomized, Phase 3 HYPRO Trial. Wortel, RC., Oomen-de Hoop, E., Heemsbergen, WD., et al.[2019]

In a clinical trial involving 201 patients with prostate cancer, the use of a hyaluronic acid rectal spacer significantly improved rectal dosimetry, with 98.5% of patients achieving a 25% or greater reduction in rectal volume receiving radiation, far exceeding the 70% target.

The spacer also reduced the incidence of acute grade 2 or higher gastrointestinal toxic effects, with only 2.9% of patients in the spacer group experiencing these effects compared to 13.8% in the control group, indicating a safer treatment option for hypofractionated radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyaluronic Acid Spacer for Hypofractionated Prostate Radiation Therapy: A Randomized Clinical Trial. Mariados, NF., Orio, PF., Schiffman, Z., et al.[2023]

Recent evidence suggests that hypofractionated radiotherapy for prostate cancer is both safe and effective, particularly with a recommended regimen of 60 Gy in 20 fractions, which showed no significant increase in late toxicity.

While moderate hypofractionation has demonstrated positive 5-year outcomes in large trials, further research is needed for extreme hypofractionation techniques, and their use should currently be restricted to clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionation for prostate cancer: an update. Tiberi, D., Vavassis, P., Nguyen, D., et al.[2019]

Hypofractionated proton therapy (PT) for prostate cancer is feasible and shows an acceptable toxicity profile, with acute gastrointestinal (GI) toxicity at 0% and acute genitourinary (GU) toxicity at 5% among 82 patients studied over a median follow-up of 42 months.

The four-year biochemical control free survival (BCFFS) rates were 85% and 86%, indicating that hypofractionated PT is as effective as conventional treatments, potentially offering patients a more efficient and cost-effective option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase II study of hypofractionated proton therapy for prostate cancer. Kim, YJ., Cho, KH., Pyo, HR., et al.[2022]

In a phase 2 trial involving 40 patients, postoperative hypofractionated intensity-modulated radiation therapy (IMRT) for prostate cancer showed favorable safety, with no severe adverse events (grade ≥3) reported.

Acute gastrointestinal (GI) toxicity was observed in 56.4% of patients (grade 1) and 17.9% (grade 2), while genitourinary (GU) toxicity was noted in 35.9% (maximum grade 1), indicating that the treatment is generally well-tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated IMRT of the prostate bed after radical prostatectomy: acute toxicity in the PRIAMOS-1 trial. Katayama, S., Striecker, T., Kessel, K., et al.[2018]

The Scandinavian HYPO-RT-PC trial, involving 1200 men with intermediate-to-high-risk prostate cancer, demonstrated that ultra-hypofractionated radiotherapy (42.7 Gy in seven fractions) is non-inferior to conventional fractionation (78.0 Gy in 39 fractions) in terms of failure-free survival over a median follow-up of 5 years.

While ultra-hypofractionation resulted in more acute urinary and bowel symptoms during treatment, late toxicity rates were similar to those of conventional fractionation, suggesting that ultra-hypofractionation is a safe and effective option for prostate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultra-hypofractionated versus conventionally fractionated radiotherapy for prostate cancer: 5-year outcomes of the HYPO-RT-PC randomised, non-inferiority, phase 3 trial. Widmark, A., Gunnlaugsson, A., Beckman, L., et al.[2019]

Moderate hypofractionated radiotherapy for prostate cancer is associated with a 6.3% increase in acute grade ≥ 2 gastrointestinal toxicity compared to standard fractionation, indicating a need for careful monitoring and management of these symptoms.

There was no significant increase in acute genitourinary toxicity or late toxicity levels between moderate hypofractionation and standard fractionation, suggesting that while acute GI symptoms may be more common, overall safety profiles for late effects are similar.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute and late toxicity patterns of moderate hypo-fractionated radiotherapy for prostate cancer: A systematic review and meta-analysis. Sinzabakira, F., Brand, V., Heemsbergen, WD., et al.[2023]

In a study involving 457 men with localized prostate cancer, hypofractionated high-dose radiotherapy (60 Gy and 57 Gy) was found to be as well tolerated as conventional radiotherapy (74 Gy) over a median follow-up of 50.5 months, with low rates of grade 2 or worse bowel and bladder toxicities.

The rates of bowel toxicity were 4.3% for the conventional group, 3.6% for the 60 Gy group, and 1.4% for the 57 Gy group, indicating that hypofractionated treatment may not increase the risk of side effects compared to standard treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: preliminary safety results from the CHHiP randomised controlled trial. Dearnaley, D., Syndikus, I., Sumo, G., et al.[2023]

In a study of 41 patients with high-risk localized prostate cancer, combining whole-pelvis irradiation with a stereotactic body radiotherapy (SBRT) boost resulted in a high 4-year biochemical failure-free survival rate of 91.9%, indicating effective cancer control.

The treatment was associated with minimal toxicity, with no severe (grade 3) gastrointestinal or genitourinary side effects reported, suggesting that this approach is safe for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The early result of whole pelvic radiotherapy and stereotactic body radiotherapy boost for high-risk localized prostate cancer. Lin, YW., Lin, LC., Lin, KL.[2020]

The PAROS trial is a large-scale, multicenter phase III study involving 897 post-prostatectomy patients, comparing the effects of hypofractionated radiotherapy (hRT) with photons and protons against standard normofractionated radiotherapy (nRT) to assess improvements in bowel-related quality of life after treatment.

The primary goal is to determine if proton therapy leads to better bowel scores compared to photon therapy, while also evaluating the non-inferiority of hRT in terms of biochemical progression-free survival, overall survival, quality of life, and toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate bed irradiation with alternative radio-oncological approaches (PAROS) - a prospective, multicenter and randomized phase III trial. Koerber, SA., Katayama, S., Sander, A., et al.[2020]

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