All studies
RecruitingPHASE3INTERVENTIONAL

Androgen Suppression Combined With Nodal Irradiation and Dose Escalated Prostate Treatment

This study is looking at new ways to treat prostate cancer that is more likely to come back. Doctors want to see if giving a higher dose of radiation over a shorter time, using a special technique called SBRT, is as good as the current standard treatment. The standard approach involves regular external radiation therapy along with tiny radioactive seeds (brachytherapy boost) placed directly into the prostate, often alongside hormone therapy. The aim is to find effective treatments that might be more convenient for patients and still keep the cancer away for a long time. Around 89 out of 100 people on the standard treatment are still cancer-free after 5 years, so this study hopes to match or improve upon that.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Canadian Cancer Trials Group
Enrolment target
710
Start
25 Apr 2024
Estimated completion
30 Apr 2033

What is this study about?

This study is exploring a new way to treat prostate cancer, particularly for men whose cancer might be more likely to return. Currently, the standard treatment often involves a combination of hormone therapy and external beam radiation, which targets the cancer from outside the body. To further reduce the chance of the cancer coming back, doctors often also recommend a 'brachytherapy boost'. This involves placing tiny radioactive seeds directly inside the prostate for a period of time, giving the cancer a more intense dose of radiation.

The main question this study wants to answer is whether a different type of radiation, called Stereotactic Body Radiation Therapy (SBRT), can be just as effective. SBRT delivers a very high dose of radiation directly to the cancer in a much smaller number of treatment sessions. This could mean fewer hospital visits and a shorter overall treatment time for patients, which would be a big benefit if it works as well as the current standard.

By comparing these two approaches, researchers hope to understand if SBRT can offer similar excellent results, where about 89 out of 100 patients are free of cancer after five years with the current standard treatment. This research is important because it could lead to new, more convenient, and equally effective treatments for prostate cancer in the future.

Key takeaways

  • Compares standard prostate cancer radiation with a new, shorter method (SBRT).
  • Focuses on prostate cancer that is more likely to return.
  • Aims for equally good results with potentially fewer hospital visits.
  • Both treatments involve hormone therapy.
  • Around 89 out of 100 men are cancer-free after 5 years with standard treatment.

Who may be eligible?

This study is looking for men aged 18 or older who have been diagnosed with prostate cancer in the last nine months. Your type of prostate cancer would need to be considered at a higher risk of returning; this is based on specific details of your diagnosis like the size of the cancer, your PSA levels (a blood test marker), and how aggressive the cancer cells look under a microscope (Gleason score).

To join, you also need to be well enough for a procedure called brachytherapy, which is part of the standard treatment being compared. You should be able to complete questionnaires about your quality of life in English, French, or Spanish, and be willing to take steps to prevent pregnancy if you're sexually active. Importantly, you'll need to give your permission to be part of the study before you start.

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.

  1. Are you a man aged 18 or over?
  2. Was your prostate cancer diagnosed in the last nine months?
  3. Has your doctor said your prostate cancer is at a higher risk of coming back?
  4. Are you generally fit enough for medical procedures like brachytherapy?
  5. Can you answer health questionnaires in English, French, or Spanish?
  6. Are you willing to prevent pregnancy, if sexually active?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the standard prostate cancer treatment (external radiation with a brachytherapy boost and hormone therapy) or the new SBRT radiation treatment along with hormone therapy. You would have regular appointments for your treatments, follow-up checks, and to complete questionnaires about your health and quality of life. The exact number of visits will depend on which treatment you receive, but you would be fully supported throughout the process. The total duration of your participation, including follow-up, would be discussed with you by the study team.

Potential risks and benefits

Taking part in a study like this could offer you access to a new treatment approach that might be more convenient. While the treatments used are well-established for prostate cancer, all medical interventions carry potential risks, such as side effects from radiation or hormone therapy, which your doctor will discuss with you. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care. Your safety and well-being are paramount, and the research team will monitor you closely.

Locations (57)

  • Kaiser Permanente-Deer Valley Medical Center
    Verified postcode
    Antioch, United States· Recruiting
  • Kaiser Permanente Dublin
    Verified postcode
    Dublin, United States· Recruiting
  • Kaiser Permanente-Fremont
    Verified postcode
    Fremont, United States· Recruiting
  • Kaiser Permanente Fresno Orchard Plaza
    Verified postcode
    Fresno, United States· Recruiting
  • Kaiser Permanente-Fresno
    Verified postcode
    Fresno, United States· Recruiting
  • Kaiser Permanente-Modesto
    Verified postcode
    Modesto, United States· Recruiting
  • Kaiser Permanente Oakland-Broadway
    Verified postcode
    Oakland, United States· Recruiting
  • Kaiser Permanente-Oakland
    Verified postcode
    Oakland, United States· Recruiting
  • Kaiser Permanente- Marshall Medical Offices
    Verified postcode
    Redwood City, United States· Recruiting
  • Kaiser Permanente-Richmond
    Verified postcode
    Richmond, United States· Recruiting
  • Rohnert Park Cancer Center
    Verified postcode
    Rohnert Park, United States· Recruiting
  • Kaiser Permanente-Roseville
    Verified postcode
    Roseville, United States· Recruiting

Common questions

What is the main goal of this study?

The goal is to see if a shorter, high-dose radiation treatment (SBRT) is as good as the usual radiation treatment for prostate cancer that is more likely to come back.

What is 'SBRT'?

SBRT stands for Stereotactic Body Radiation Therapy. It's a way of giving a very focused, high dose of radiation in fewer treatment sessions.

What is 'brachytherapy boost'?

Brachytherapy boost means tiny radioactive seeds are placed directly into the prostate to give the cancer an extra dose of radiation.

Will I receive hormone therapy?

Both treatment options in this study include hormone therapy (ADT), which helps reduce the amount of male hormones that can make prostate cancer grow.

How long has my prostate cancer diagnosis need to be for this study?

Your prostate cancer must have been diagnosed within the last nine months to be eligible for this study.

How to find out more

Wendy Parulekar

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Androgen Suppression Combined With Nodal Irradiation and Dos…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.