What side effects are associated with this type of intervention?

Stereotactic Body Radiation Therapy (SBRT) for prostate cancer, which involves high doses of radiation delivered in a few sessions, can lead to several side effects. Commonly reported side effects include urinary symptoms such as frequency, urgency, and discomfort, as well as bowel symptoms like rectal pain, bleeding, and diarrhea. Erectile dysfunction is also a potential side effect. While SBRT aims to minimize damage to surrounding tissues, some patients may experience fatigue and skin irritation. Long-term risks include the potential for more severe late toxicities, although these are less common.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer that involve high doses of radiation delivered in a few sessions, similar to Stereotactic Body Radiation Therapy (SBRT). SBRT is known for its precision in targeting cancer cells while minimizing damage to surrounding tissues. While specific FDA approvals for SBRT in prostate cancer may not be detailed, the broader category of radiation therapies, including external beam radiation therapy (EBRT) and brachytherapy, have been widely used and approved for prostate cancer treatment. These therapies aim to deliver high doses of radiation to the prostate with precision, improving outcomes and reducing side effects.

What other types of research exist?

Promising alternatives to Ultra-Hypofractionated Post-Prostatectomy Radiation Therapy (SBRT) for prostate cancer patients include: 1) Androgen Deprivation Therapy (ADT) combined with docetaxel and darolutamide for high-risk/high-volume metastatic castration-sensitive prostate cancer (CSPC). 2) ADT combined with abiraterone for patients who are not candidates for docetaxel. 3) Stereotactic Body Radiation Therapy (SBRT) combined with transcatheter arterial chemoembolization for small hepatocellular carcinoma, which may be adapted for prostate cancer. These alternatives offer targeted treatment with potential for improved outcomes and manageable side effects.

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Radiation Therapy

Moderate vs Ultra-Hypofractionated Radiation for Prostate Cancer

Phase 2

Recruiting

Led By William Jackson, M.D.

Research Sponsored by University of Michigan Rogel Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to obtain tissue from radical prostatectomy specimen for review by Michigan Medicine Pathology

Interval between prostatectomy and planned radiation therapy start date ≥ 6 months

Must not have

History of moderate/severe or active Crohn's disease or ulcerative colitis

History of bladder neck or urethral stricture

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial compares the quality of life of prostate cancer patients treated with a short-term, high-dose radiation therapy to those treated with the standard, longer-term radiation therapy. The new method aims to reduce the number of treatments, making it easier for patients to complete their treatment and potentially improve their quality of life. This newer radiotherapy method for prostate cancer aims to shorten the treatment duration and improve patient convenience.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Radiation therapy side effects may include skin changes, fatigue, urinary issues like increased frequency or discomfort, bowel changes such as diarrhea or rectal bleeding, and potential sexual dysfunction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can provide tissue from my prostate surgery for review.

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

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I am a man over 18 with prostate cancer confirmed by biopsy after surgery, and my PSA level is at least 0.1 ng/mL.

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I am mostly able to care for myself.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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My cancer has spread to distant areas or to nodes beyond my pelvis.

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I haven't had any cancer except for skin cancer in the last 3 years.

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I have had radiation therapy in the pelvic area before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in patient reported GI and GU quality of life (QOL) at 2-years post-treatment from baseline

Secondary study objectives

Local failure, Regional failure, Distant metastases

Overall survival

Patient reported GI quality of life (QOL) up to 60 months

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Ultra-Hypofractionated Radiation TherapyExperimental Treatment1 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 TherapyActive Control1 Intervention

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

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Prostate cancer treatments primarily include androgen deprivation therapy (ADT) and radiation therapy. ADT works by lowering testosterone levels, which prostate cancer cells rely on for growth, thereby slowing disease progression. Stereotactic Body Radiation Therapy (SBRT) delivers high doses of radiation in a few sessions, precisely targeting cancer cells while sparing surrounding healthy tissue. This precision reduces side effects and improves the quality of life for patients. Understanding these mechanisms is crucial for patients as it helps them make informed decisions about their treatment options, balancing efficacy and potential side effects.

Stereotactic body radiation therapy for prostate cancer: systematic review and meta-analysis of prospective trials.