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

13 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary objective of this study is to demonstrate that ultra-hypofractionation of prostate cancer does not increase urinary toxicity as defined by the EPIC-26 GU domain patient reported outcome.

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 data supports the effectiveness of the treatment Hypofractionated Radiation for Prostate Cancer?

Research shows that hypofractionated radiotherapy, which involves giving larger doses of radiation over fewer sessions, can be as effective as traditional methods for treating prostate cancer. Studies indicate it may control the cancer just as well without increasing side effects, making it a promising option for patients. ^{1 2 3 4 5}

Is hypofractionated radiation therapy safe for humans?

Hypofractionated radiation therapy for prostate cancer is generally considered safe, but it may cause more short-term side effects like gastrointestinal issues compared to traditional methods. Long-term safety data is reassuring, with no significant increase in late side effects reported in large studies. ^{6 7 8 9 10}

How is hypofractionated radiation treatment different from other treatments for prostate cancer?

Hypofractionated radiation treatment for prostate cancer is unique because it delivers higher doses of radiation in fewer sessions, which can shorten the overall treatment time compared to conventional radiation therapy. This approach takes advantage of prostate cancer's sensitivity to radiation, potentially increasing the effectiveness of the treatment without increasing side effects. ^{1 3 10 11 12}

Research Team

Xinglei Shen

Principal Investigator

University of Kansas Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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 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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

A phase II study of hypofractionated proton therapy for prostate cancer. [2022]

3. England 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. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Sexual Function After Hypofractionated Versus Conventionally Fractionated Radiotherapy for Prostate Cancer: Results From the Randomized Phase III HYPRO Trial. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Randomized Trial of Hypofractionated, Dose-Escalated, Intensity-Modulated Radiation Therapy (IMRT) Versus Conventionally Fractionated IMRT for Localized Prostate Cancer. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Hyaluronic Acid Spacer for Hypofractionated Prostate Radiation Therapy: A Randomized Clinical Trial. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Hypofractionation for prostate cancer: an update. [2019]

8. Ireland pubmed.ncbi.nlm.nih.gov

Acute and late toxicity patterns of moderate hypo-fractionated radiotherapy for prostate cancer: A systematic review and meta-analysis. [2023]

9. England 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. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Hypofractionated IMRT of the prostate bed after radical prostatectomy: acute toxicity in the PRIAMOS-1 trial. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Prostate bed irradiation with alternative radio-oncological approaches (PAROS) - a prospective, multicenter and randomized phase III trial. [2020]

12. United States 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. [2019]