Active not recruitingNAINTERVENTIONAL

Focal Salvage HDR Brachytherapy for the Treatment of Prostate Cancer

This study is for men whose prostate cancer has returned only in the prostate after previous radiation treatment. While there are other ways to treat this, they all have risks and doctors don't yet agree on the best approach. This new pilot study explores a targeted treatment using radioactive seeds (called 'focal salvage HDR brachytherapy'). Instead of treating the entire prostate, this method aims to treat only the specific area where the cancer has returned. The researchers hope that by focusing the treatment, there will be fewer side effects for patients. If you have prostate cancer that has returned locally and you meet certain health criteria, you might be able to take part.

At a glance

Status

Active not recruiting

Phase

Sponsor

Sunnybrook Health Sciences Centre

Enrolment target

Start

01 Jul 2012

Estimated completion

01 Jul 2028

Prostate Cancer

What is this study about?

When prostate cancer is first found, radiation therapy is a common treatment. However, for about 20 to 30 out of every 100 men, the cancer can come back. Sometimes, it only comes back in the prostate itself, meaning it hasn't spread to other parts of the body. If this type of isolated recurrence isn't treated, it could potentially spread later.

Currently, there are several ways to treat prostate cancer that has come back only in the prostate. These include placing temporary or permanent radioactive seeds in the prostate, completely removing the prostate gland surgically, using very cold temperatures to destroy cancer cells (cryotherapy), or using strong sound waves to heat and destroy cancer cells (HIFU). The challenge is that all these treatments come with risks of side effects, and doctors don't yet know which one is the very best option for everyone.

This specific study is a pilot, meaning it's an initial investigation, to see if a more targeted approach called 'focal salvage HDR brachytherapy' is a good idea. Instead of treating the whole prostate gland, the doctors aim to treat only the small area where the cancer has recurred. They will use temporary radioactive seeds for this. The main goal is to find out if this focused treatment is practical and if it causes fewer side effects, especially since a smaller area is being treated. This could potentially offer a gentler option for men facing a local recurrence of their prostate cancer.

Key takeaways

This study is for prostate cancer that has returned only in the prostate after prior radiation treatment.
It uses a targeted radiation method (focal HDR brachytherapy) with temporary radioactive seeds.
The goal is to treat only the affected area, hoping for fewer side effects.
It's a pilot study, meaning it's an early investigation into this specific approach.
Participation requires meeting strict health and treatment history criteria.

Who may be eligible?

This study is looking for men who have prostate cancer that has returned specifically in the prostate, even after they've had previous radiation treatment. To be considered, doctors need to have confirmed this recurrence with a biopsy at least 30 months (or two and a half years) after your last treatment. Imaging scans, like MRI, must show that the cancer is only in the prostate and hasn't spread anywhere else in your body.

You also need to be generally in good health, with an American Urological Association Symptom Index Score (a way to measure urinary symptoms) less than 15. Your PSA level after your previous radiation treatment should be less than 10 ng/mL, and your prostate size, measured by ultrasound, should be less than 50 cubic centimetres. You must be able to perform most daily activities without difficulty.

However, you cannot take part if you've already had certain other prostate treatments like specific surgeries (TURP or prostatectomy), other types of radioactive seed implants (permanent or temporary brachytherapy), freezing treatment (cryosurgery), HIFU, or certain hormone treatments or chemotherapy for prostate cancer. Also, if your cancer has shown signs of resisting hormone therapy (castrate resistance), you won't be able to join this study.

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.

Has your prostate cancer returned only in your prostate after previous radiation treatment?
Was this recurrence confirmed by a biopsy at least 2.5 years (30 months) after your last treatment?
Do scans show the cancer is only in your prostate and hasn't spread?
Is your American Urological Association Symptom Index Score (a measure of urinary symptoms) less than 15?
Have you NOT had previous treatments like certain surgeries (TURP, prostate removal), other types of radioactive seed implants, freezing, HIFU, or certain hormone/chemotherapy treatments for prostate cancer?
Are you generally able to do most daily activities without difficulty?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive a specific type of radiation treatment called focal salvage HDR brachytherapy, where temporary radioactive seeds are placed directly into the area of your prostate where the cancer has returned. The study aims to look at how well this focused treatment works and what side effects it might have. The exact number of visits, specific assessments, and the full duration of follow-up will be explained in detail by the study team, as this information is not fully provided in the summary. You will likely have regular check-ups, blood tests (like PSA measurements), and possibly imaging scans to monitor your health and the treatment's effect.

Potential risks and benefits

Potential benefits of participating in this study include receiving a new, potentially less invasive treatment for recurrent prostate cancer, which aims to reduce side effects by focusing on a smaller area. This could offer an alternative if other treatments are not suitable or if you prefer a more targeted approach. However, like all medical treatments, there are potential risks, including side effects from the radiation, which could affect your bladder, bowel, or sexual function, even with a targeted approach. The full extent of these risks and any potential complications will be discussed with you by the study team. You always have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

Sunnybrook Health Sciences Centre, Odette Cancer Centre
Verified postcode
Toronto, Canada

Common questions

What does 'focal salvage HDR brachytherapy' mean?

It's a special type of radiation treatment where temporary radioactive seeds are placed directly into a small, specific area of the prostate where cancer has returned, rather than treating the whole gland.

Why is this study important?

It's trying to find a better way to treat prostate cancer that has come back in the prostate after previous treatment, hoping to reduce side effects by focusing the treatment more precisely.

Has this treatment been used before?

While brachytherapy is a known treatment, this study is specifically looking at using it in a 'focal' way (treating only a small area) for 'salvage' (after a previous treatment failed) in this particular situation. It's a pilot study, which means it's an early investigation.

What are the main things they are looking for in this study?

The study primarily aims to see if this focused treatment is practical to perform and what side effects, if any, patients experience (this is called looking at 'feasibility and toxicities').

Will I have to stay in hospital?

The summary doesn't specify, but often, procedures involving radioactive seeds require a short hospital stay, or at least extensive preparation and recovery periods.