Active not recruitingPHASE3INTERVENTIONAL

Stereotactic Body Radiation Therapy or Intensity-Modulated Radiation Therapy in Treating Patients With Stage IIA-B Prostate Cancer

This research study is for men with early-stage prostate cancer (Stage IIA-B). It's comparing two advanced types of radiation therapy: Stereotactic Body Radiation Therapy (SBRT) and Intensity-Modulated Radiation Therapy (IMRT). SBRT uses very precise, high-dose radiation over fewer sessions, while IMRT uses lower doses over more sessions. The main goals are to find out which treatment causes fewer side effects related to bladder and bowel function, and which one is better at preventing the cancer from coming back. Researchers will also look at how these treatments affect your overall quality of life. This is a Phase 3 trial, meaning it's comparing a new approach (SBRT) against a standard one (IMRT) that is already widely used.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

NRG Oncology

Enrolment target

692

Start

01 Feb 2018

Estimated completion

01 Dec 2027

Stage II Prostate Adenocarcinoma AJCC v7

What is this study about?

This study is designed for men who have been diagnosed with early-stage prostate cancer, specifically Stage IIA-B. The main purpose is to compare two modern types of radiation treatment: Stereotactic Body Radiation Therapy (SBRT) and Intensity-Modulated Radiation Therapy (IMRT). Both use high-energy X-rays to destroy cancer cells and shrink tumours, but they deliver the treatment differently.

IMRT is a common and effective treatment. SBRT, however, uses highly focused beams of radiation, allowing doctors to deliver higher doses to the tumour in fewer treatment sessions. This precision aims to spare healthy tissues nearby, potentially leading to fewer side effects and a shorter overall treatment period. Imagine it like aiming a very precise spotlight directly at the cancer, rather than a broader floodlight. The study wants to find out if SBRT can be more effective and cause fewer side effects than IMRT.

Doctors in this study are especially interested in your quality of life. They will closely monitor and compare how these treatments affect your daily life, particularly focusing on any changes to your bladder and bowel function. They also want to see which treatment is better at keeping the cancer from returning over time. This research is important because it could help doctors decide the best way to treat prostate cancer in the future, improving outcomes and reducing side effects for patients.

Key takeaways

Compares two radiation treatments for early prostate cancer.
Aims to find treatments with fewer side effects and better results.
Your quality of life, especially bladder/bowel health, is a key focus.
Involves regular check-ups and questionnaires over time.
You will be randomly assigned to one of the treatment groups.

Who may be eligible?

This study is looking for men aged 18 or older who have been diagnosed with early-stage prostate cancer (Stage IIA-B). You must not have had any previous local treatments for your prostate cancer, such as surgery or other types of radiation. The size of your prostate also needs to be less than 70 cubic centimetres. Your diagnosis must meet specific criteria regarding the cancer's grade (Gleason score) and the level of a protein called PSA in your blood.

To be considered, your overall health and ability to carry out daily activities should be good, as determined by a doctor's assessment. If you are currently under 'active surveillance' (where your cancer is being monitored without immediate treatment) and you now wish to have treatment, you might also be eligible, as long as you meet all the other requirements.

Also, your doctors will need to have performed a digital rectal exam (DRE) and an MRI scan of your prostate and pelvis recently to ensure you fit the study's specific health profiles.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you male and 18 years or older?
Do you have early-stage prostate cancer (Stage IIA-B)?
Have you *not* had any previous prostate cancer treatments like surgery or radiation?
Is your overall health generally good?
Has your doctor confirmed your prostate size and cancer details meet the study's specific requirements?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to receive either Stereotactic Body Radiation Therapy (SBRT) or Intensity-Modulated Radiation Therapy (IMRT). This means you won't get to choose which type of radiation you receive, similar to flipping a coin. Both treatments involve multiple visits to the hospital for your radiation sessions.

Throughout the study, you will have regular follow-up appointments. These appointments will involve check-ups with your doctor and answering questionnaires about your health and quality of life. These questionnaires are important because they help the researchers understand how the treatments are affecting you day-to-day, especially concerning your bladder and bowel functions, and your overall well-being. The total duration of your participation in the study, including follow-up, will be determined by the study protocol, but typically involves monitoring for at least 24 months after your treatment finishes.

Potential risks and benefits

Participating in this study might offer you access to a potentially more advanced radiation treatment (SBRT) that could have fewer side effects or be more effective than standard treatment. However, as with any medical treatment, there are potential risks, including side effects from the radiation therapies, which will be discussed in detail by your medical team. You also have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care. The medical team will ensure you understand all potential benefits and risks before you make a decision.

Locations (293)

Mobile Infirmary Medical Center
Verified postcode
Mobile, United States
Lewis and Faye Manderson Cancer Center
Verified postcode
Tuscaloosa, United States
Arizona Center for Cancer Care - Gilbert
Verified postcode
Gilbert, United States
Arizona Center for Cancer Care-Peoria
Verified postcode
Peoria, United States
Arizona Center for Cancer Care - Scottsdale
Verified postcode
Scottsdale, United States
Arizona Center for Cancer Care-Surprise
Verified postcode
Surprise, United States
Arizona Oncology Associates-West Orange Grove
Verified postcode
Tucson, United States
University of Arkansas for Medical Sciences
Verified postcode
Little Rock, United States
Kaiser Permanente-Anaheim
Verified postcode
Anaheim, United States
Alta Bates Summit Medical Center-Herrick Campus
Verified postcode
Berkeley, United States
Mercy Cancer Center - Carmichael
Verified postcode
Carmichael, United States
Mercy San Juan Medical Center
Verified postcode
Carmichael, United States

Common questions

What is 'randomly assigned'?

It means you'll be put into one of the treatment groups by chance, like drawing lots, so neither you nor your doctor can choose which treatment you get.

How long will my treatment last?

The SBRT treatment usually involves fewer sessions over a shorter period than IMRT, but the exact duration will be explained by the study team.

Will I have to pay to be in the study?

No, treatments and study-related assessments will typically be covered as part of the research.

What does 'quality of life' mean in this study?

It refers to how your daily life is affected by the treatment, particularly focusing on your bladder, bowel, and sexual health.

Can I still take my regular medications?

You should discuss all your current medications with the study team, as some might need to be adjusted or stopped for the study.