Moderate vs Ultra-Hypofractionated Radiation for Prostate Cancer

Overseen By Cancer AnswerLine

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: University of Michigan Rogel Cancer Center

Must not be taking: Androgen deprivation therapy

Disqualifiers: Pelvic radiation, Crohn's, Ulcerative colitis, 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

Compensation: Varies

Number of Visits: Unknown

Duration: 3-6 weeks

136 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how different radiation therapies impact the quality of life for prostate cancer patients two years post-treatment. It compares a standard radiation treatment administered over 5-6 weeks to a newer, shorter treatment completed in 3-4 weeks. Men who have undergone prostate cancer surgery and have a PSA level of 0.1 ng/mL or higher may qualify for this study. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant advancements in prostate cancer care.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on androgen deprivation therapy, there are specific conditions regarding its initiation and type that may affect your eligibility.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that moderately hypofractionated radiation therapy effectively and safely treats prostate cancer. Research found that patients tolerated it well, with no serious side effects, and it works as well as traditional radiation treatments.

For ultra-hypofractionated radiation therapy, studies indicate it also lacks severe short-term side effects. However, about 15% of patients experienced side effects weeks or months after treatment. These side effects were not severe, and the treatment effectively controlled the cancer.

In summary, both treatments are generally safe, but ultra-hypofractionated therapy might have a slightly higher chance of later side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for prostate cancer because they offer potentially more convenient and faster radiation therapy options. Moderately hypofractionated radiation therapy delivers treatment over 5-6 weeks with 20 sessions, while ultra-hypofractionated therapy reduces this to just 5 sessions over 3-4 weeks. This significant reduction in treatment time could improve patient comfort and adherence, offering a more practical solution without compromising effectiveness. Additionally, having fewer radiation sessions means patients spend less time in treatment, which could lead to quicker recovery and a better quality of life.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

This trial will compare moderately hypofractionated radiation therapy (MHFRT) with ultra-hypofractionated radiation therapy for localized prostate cancer. Studies have shown that MHFRT performs as well as traditional radiation treatment, with no significant difference in cancer recurrence rates after five years. Long-term evidence also indicates that MHFRT offers similar survival rates compared to standard treatments.

Ultra-hypofractionated radiation therapy, another treatment option in this trial, has effectively controlled prostate cancer without severe early side effects, according to research. Some studies suggest that the local recurrence rate is similar to other treatments. While long-term data remains limited, initial findings are promising for its effectiveness in controlling prostate cancer. ^{3 6 7 8 9}

Who Is on the Research Team?

William Jackson, M.D.

Principal Investigator

University of Michigan Rogel Cancer Center

Are You a Good Fit for This Trial?

Men aged 18+ who've had prostate cancer confirmed by tissue review after surgery, with a PSA level of at least 0.1 ng/mL. They should be able to start radiation therapy at least 6 months post-surgery and have a KPS score of 70 or above, indicating they can carry out daily activities. Participants must be capable of completing a quality-of-life survey and provide consent.

Inclusion Criteria

I can provide tissue from my prostate surgery for review.

My pelvic lymph nodes are small or unclear on scans, and any suspicious areas outside the pelvis have been biopsied and are cancer-free.

It has been 6 months or more since my prostate surgery.

Exclusion Criteria

I have a history of moderate to severe Crohn's disease or ulcerative colitis.

Any condition that in the opinion of the investigator would preclude participation in this study

I have had a narrowing of my bladder neck or urethra.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either moderately hypo-fractionated radiation therapy over 5-6 weeks or ultra-hypofractionated radiation therapy over 3-4 weeks

3-6 weeks

Follow-up

Participants are monitored for safety, effectiveness, and quality of life after treatment

60 months

What Are the Treatments Tested in This Trial?

Interventions

• Moderately Hypo-fractionated Radiation Therapy
• Ultra-hypofractionated radiation therapy

Trial Overview This study compares two types of radiation therapy for prostate cancer patients after surgery: ultra-hypofractionated (SBRT) versus moderately hypo-fractionated radiation. The main goal is to see which treatment leads to better self-reported quality of life two years later.

How Is the Trial Designed?

Group I: Ultra-Hypofractionated Radiation Therapy Experimental Treatment 1 Intervention

5 fractions of ultra-hypofractionated radiation therapy with at least one day between each treatment over the course of no more than 3-4 weeks

Group II: Moderately Hypo-fractionated Radiation Therapy Active Control 1 Intervention

20 fractions of moderately hypofractionated radiation therapy over no more than 5-6 weeks.

Moderately Hypo-fractionated Radiation Therapy is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Moderately Hypo-fractionated Radiation Therapy for:

• Prostate cancer

Approved in United States as Moderately Hypo-fractionated Radiation Therapy for:

• Prostate cancer

Approved in Canada as Moderately Hypo-fractionated Radiation Therapy for:

• Prostate cancer

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials

303

Recruited

20,700+

Published Research Related to This Trial

In a study involving 874 men with localized prostate cancer, stereotactic body radiotherapy (SBRT) was found to have similar rates of acute gastrointestinal and genitourinary toxicity compared to conventionally fractionated or moderately hypofractionated radiotherapy, suggesting that shorter treatment courses do not increase immediate side effects.

The study showed that only 12% of patients receiving conventional treatment experienced severe gastrointestinal toxicity, compared to 10% in the SBRT group, and 27% versus 23% for genitourinary toxicity, indicating that SBRT is a safe alternative without compromising patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated fractionated radiotherapy versus stereotactic body radiotherapy for prostate cancer (PACE-B): acute toxicity findings from an international, randomised, open-label, phase 3, non-inferiority trial. Brand, DH., Tree, AC., Ostler, P., et al.[2022]

In a pilot study involving 24 patients with low- to intermediate-risk prostate cancer, highly hypofractionated intensity modulated radiation therapy (IMRT) delivered 54 Gy in 15 fractions over 3 weeks resulted in high survival rates: 91.7% biochemical relapse-free survival and 95.8% overall survival at 5 years.

The treatment was well-tolerated, with no severe late gastrointestinal or grade ≥3 genitourinary toxicities observed, suggesting that this approach may be a safe and effective alternative to traditional radiation therapy methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Outcomes of a Prospective Study on Highly Hypofractionated Intensity Modulated Radiation Therapy for Localized Prostate Cancer for 3 Weeks. Nakamura, K., Ikeda, I., Inokuchi, H., et al.[2023]

A systematic review of 25 studies involving 4821 prostate cancer patients showed that ultrahypofractionated stereotactic body radiation therapy (SBRT) can achieve high tumor control probabilities (TCP) of 90% to 95% with specific dose regimens, indicating its efficacy in treating localized prostate cancer.

Despite variations in treatment protocols, the study found that doses of 31.7 Gy to 36.1 Gy in 5 fractions for low-intermediate risk patients and 37.6 Gy to 38.7 Gy in 5 fractions for high-risk patients were effective, highlighting the potential of SBRT for dose escalation and shorter treatment times.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tumor Control Probability Modeling and Systematic Review of the Literature of Stereotactic Body Radiation Therapy for Prostate Cancer. Royce, TJ., Mavroidis, P., Wang, K., et al.[2022]

In a study of 41 hormone-naïve intermediate-risk prostate cancer patients treated with hypofractionated SBRT, the treatment resulted in a significant decrease in PSA levels from an average of 7.67 ng/mL to 0.64 ng/mL at a median follow-up of 21 months, indicating effective early clinical outcomes.

No severe toxicities (Grade 3 or 4) were observed, and while there was a temporary decline in urinary and bowel quality of life scores post-treatment, they returned to baseline levels, suggesting that SBRT is a safe option for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated stereotactic body radiation therapy as monotherapy for intermediate-risk prostate cancer. Ju, AW., Wang, H., Oermann, EK., et al.[2021]

Stereotactic ablative radiotherapy (SABR) has been shown to be feasible and well tolerated for low- and intermediate-risk prostate cancer patients, with promising results from large randomized studies comparing it to conventional treatments.

While SABR shows potential benefits and cost-effectiveness, there is currently insufficient data to recommend its use for high-risk prostate cancer patients outside of clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Body Radiotherapy for Intermediate- or High-Risk Prostate Cancer. Loblaw, A.[2021]

In the HYPO-RT-PC trial involving 1180 patients with localized prostate cancer, ultra-hypofractionated radiotherapy showed higher acute toxicity compared to conventional fractionation, particularly in bowel symptoms, but long-term quality of life (QOL) was similar between the two treatment methods up to 6 years post-treatment.

Despite the initial increase in bowel-related issues for patients receiving ultra-hypofractionation, there were no significant differences in urinary, bowel, or sexual functioning between the two groups after the treatment period, indicating that ultra-hypofractionation is a viable option for patients with intermediate-to-high-risk prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultra-hypofractionated versus conventionally fractionated radiotherapy for prostate cancer (HYPO-RT-PC): patient-reported quality-of-life outcomes of a randomised, controlled, non-inferiority, phase 3 trial. Fransson, P., Nilsson, P., Gunnlaugsson, A., et al.[2021]

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]

A systematic review of studies on stereotactic body radiation therapy (SBRT) for prostate cancer found that most patients experienced mild to moderate side effects, with severe toxicity occurring in less than 3% of cases, indicating that SBRT is generally well tolerated.

The review identified important dosimetric factors that influence toxicity, such as recommended dose constraints for the bladder, urethra, and rectum, which can help optimize treatment safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate Stereotactic Body Radiation Therapy: An Overview of Toxicity and Dose Response. Wang, K., Mavroidis, P., Royce, TJ., et al.[2022]

Moderately hypofractionated external beam radiotherapy (2.4-3.4 Gy per fraction) provides similar biochemical control for localized prostate cancer as conventional radiotherapy, without increasing late toxicity, making it a preferred treatment option for many patients.

Ultrahypofractionated radiotherapy (SBRT, at least 5 Gy per fraction) shows promising results in biochemical control and acceptable toxicity, particularly in low- and intermediate-risk prostate cancer, suggesting it could be a viable alternative to traditional treatment methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated Radiotherapy for Localized Prostate Cancer: When and for Whom? Roy, S., Morgan, SC.[2020]

Citations

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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. foxchase.org foxchase.org/news/2020-03-10-ten-year-data-shows-same-outcomes-hypofractionated-radiation-versus-conventional-radiation

Ten-Year Data Shows Same Outcomes for ... Conventional fractionated and moderate hypofractionated radiation therapy for localized prostate cancer were equally effective.

3. 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7532562/

Long-term outcomes of moderately hypofractionated ... Ten-year outcomes of moderately hypofractionated (70 Gy in 28 fractions) intensity modulated radiation therapy for localized prostate cancer. Int J Radiat ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1278321825000940

Moderate hypofractionated radiotherapy for localised ... Overall, 12-year estimated survival rate was similar at 68.7 % for conventional fractionation and 69.9 % for modest hypofractionation (HR: 1.01). The most ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6000067/

Outcomes and toxicity from a prospective study of ... Our results show that moderate hypofractionation with 64 Gy in 20 fractions is feasible and safe in patients with low- to intermediate-risk prostate cancer.

7. sciencedirect.com sciencedirect.com/science/article/pii/S240563082300037X

Review Article Acute and late toxicity patterns of moderate ... Recent randomized clinical trials (RCTs) have shown that moderate hypofractionation (HF) in prostate cancer treatment is effective and safe [2], [3], [4], [5], ...

8. oncologynurseadvisor.com oncologynurseadvisor.com/features/moderately-hypofractionated-radiotherapy-in-prostate-cancer/

Hypofractionated Radiotherapy in Prostate Cancer Both isodose & dose-escalated MHFRT offer rates of progression-free & overall survival comparable to those seen with conventional ...

9. oncotarget.com oncotarget.com/article/13735/text/

Moderate hypofractionated radiotherapy is more effective ... This study showed that higher doses of radiation were superior to the conventional dose in low-,intermediate-, and high-risk prostate cancer ...