Active not recruitingNAINTERVENTIONAL

SPCG17: Prostate Cancer Active Surveillance Trigger Trial

Many men with prostate cancer might be having treatments they don't necessarily need. This study, called SPCG17, is investigating a different approach called 'active surveillance'. This means carefully watching your prostate cancer rather than treating it right away. Treatment is only offered if the cancer shows signs of growing or becoming more serious. The study aims to create clear guidelines for when to do follow-up tests, like scans or biopsies, and when to start treatment. They are comparing these new guidelines with how doctors currently manage active surveillance. The main goal is to reduce side effects from unnecessary treatments, without increasing the risk of the cancer getting worse or affecting your lifespan.

At a glance

Status

Active not recruiting

Phase

Sponsor

Uppsala University

Enrolment target

2,008

Start

03 Oct 2016

Estimated completion

01 Dec 2034

Prostate Cancer

What is this study about?

Imagine you've been told you have prostate cancer, but your doctors think it's very slow-growing and might not cause problems for a long time. In cases like this, instead of jumping straight into treatment, doctors might suggest 'active surveillance'. This means keeping a close eye on the cancer with regular check-ups, scans, and blood tests, and only starting more intensive treatment if there are signs it's becoming more aggressive.

The SPCG17 study is all about making this 'active surveillance' even better and safer. Currently, different doctors and hospitals might have slightly different ways of deciding when to do follow-up tests or when to start active treatment. This study wants to find out if having a clear, step-by-step plan for everyone could help. They believe this could mean fewer men having treatments they don't really need, which avoids unnecessary side effects like problems with urinating or sexual function.

To do this, the study is comparing two groups of men. One group will continue with active surveillance managed in the way their local hospital usually does. The other group will follow a new, more detailed set of guidelines for when to have repeat tests and when to consider treatment. By comparing these two groups, researchers hope to show that these clear guidelines can safely reduce the number of men who have unnecessary treatments, without increasing the risk of the cancer spreading or becoming life-threatening.

Key takeaways

This study helps understand the best approach for 'active surveillance' of prostate cancer.
It aims to reduce unnecessary treatments and their side effects.
You'll be carefully monitored with regular PSA tests, exams, and MRI scans.
The study compares standard care with new, specific guidelines for monitoring.
Participation could help improve care for future prostate cancer patients.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for men who have recently (within the last year) been diagnosed with prostate cancer. Your cancer should be considered low-risk, meaning it's confined to the prostate and isn't too aggressive. Your doctor will look at specific details from your biopsy, like the Gleason score, and your PSA blood test results to determine if your cancer fits these criteria.

It's important that you are generally healthy and expected to live for at least another 10 years, as this study involves long-term monitoring. You also need to be well enough to have curative treatment, such as surgery or radiation, if your cancer does show signs of progressing while you're on active surveillance. Finally, you'll need to understand what the study involves and agree to take part by signing a consent form.

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.

Have I been diagnosed with prostate cancer in the last 12 months?
Is my prostate cancer considered low-risk by my doctor?
Am I generally healthy and expected to live for at least 10 more years?
Would I be able to have treatment like surgery or radiation if my cancer progressed?
Am I comfortable with regular check-ups and scans?
Am I willing to have repeat biopsies if my cancer shows signs of change?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly assigned to one of two groups, like flipping a coin. You won't get to choose which group you're in. Both groups will have regular check-ups: a PSA blood test every six months, a full clinical examination (including a PSA test) once a year, and an MRI scan every two years. The main difference between the groups is what 'triggers' (or signals) lead to repeat biopsies and, if necessary, the start of more active treatment.

One group will follow the usual practice of their local hospital for when to do repeat biopsies and consider treatment. The other group will follow a new set of clear, specific guidelines for these decisions. This means some men might have repeat biopsies sooner or later depending on their group. The study will carefully monitor you over time to see how the cancer behaves in both groups. The total duration of your participation will depend on how your cancer progresses, but active surveillance itself is a long-term approach.

Potential risks and benefits

Potential benefits of participating include contributing valuable information that could help many men with prostate cancer in the future, as well as potentially avoiding or delaying treatments that can have side effects. You will receive very careful and regular monitoring of your cancer. Potential risks may include the stress of living with active surveillance, and the possibility of having repeat biopsies which carry small risks like infection or bleeding. There's also a small chance that, despite careful monitoring, the cancer could progress. You are always free to withdraw from the study at any time without affecting your usual medical care.

Locations (23)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Rigshospitalet
Verified postcode
Copenhagen, Denmark
Odense University Hospital
Verified postcode
Odense, Denmark
Helsinki University Hospital
Verified postcode
Helsinki, Finland
Seinäjoki Central Hospital
Verified postcode
Tampere, Finland
Ålesund Regional Hospital
Verified postcode
Ålesund, Norway
Oslo University Hospital
Verified postcode
Oslo, Norway
University Hospital of North Norway
Verified postcode
Tromsø, Norway
St Olavs University Hospital
Verified postcode
Trondheim, Norway
Hospital of Vestfold
Verified postcode
Tønsberg, Norway
Sahlgrenska University Hospital
Verified postcode
Gothenburg, Sweden
Linköping University Hospital
Verified postcode
Linköping, Sweden
Sunderby Regional Hospital
Verified postcode
Luleå, Sweden

Common questions

What is 'active surveillance'?

Active surveillance means closely watching your prostate cancer with regular tests instead of treating it right away. Treatment only starts if the cancer shows signs of growing or becoming more serious.

Why is this study important?

Many men with prostate cancer might not need immediate treatment. This study aims to find the best way to manage active surveillance to avoid unnecessary treatments and their side effects, while still keeping men safe.

Will I have to have treatment if I join?

Not necessarily. The goal of active surveillance is to avoid or delay active treatment if the cancer isn't aggressive. Treatment will only be recommended if your cancer shows signs of advancing.

What kind of tests will I have?

You'll have regular PSA blood tests, annual physical exams, and MRI scans every two years. Depending on your assigned group, you might also have repeat biopsies based on specific triggers.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time without having to give a reason. Your ongoing medical care will not be affected.