Active not recruitingNAINTERVENTIONAL

Impact of Radical Prostatectomy as Primary Treatment in Patients With Prostate Cancer With Limited Bone Metastases

This study aims to understand if an operation called a radical prostatectomy, which removes the prostate and nearby lymph nodes, can benefit men with prostate cancer that has spread to a small number of bones. Researchers want to see if surgery, alongside standard drug therapy, leads to better survival rates, slows down the cancer's progression, and improves a patient's overall quality of life, compared to just using drug therapy. The study will also explore how personal factors and the cancer's specific characteristics might influence these results. The study originally planned for five years, but because prostate cancer can grow slowly, it has been extended for another five years to get a clearer picture of the long-term effects.

At a glance

Status

Active not recruiting

Phase

Sponsor

Martini-Klinik am UKE GmbH

Enrolment target

452

Start

01 May 2015

Estimated completion

31 Dec 2026

Prostate Cancer

What is this study about?

Imagine you have prostate cancer that has started to spread a little to your bones. Doctors are constantly looking for the best ways to treat cancer, and sometimes, new ideas emerge. This study is exploring whether an operation called a radical prostatectomy, which removes the prostate gland, could be helpful even when the cancer has spread a little bit.

Traditionally, if prostate cancer spread beyond the prostate, surgery wasn't usually considered the main treatment. However, recent research has shown that for some men whose prostate cancer has spread to nearby lymph nodes, surgery has actually led to them living longer. This has made doctors wonder if similar benefits could be seen for men whose cancer has spread to a few bones.

So, this study wants to compare two main approaches: giving men standard drug treatments for prostate cancer, versus giving them standard drug treatments *plus* the radical prostatectomy surgery. The main goal is to see if adding surgery helps men live longer, keeps the cancer from getting worse for a longer time, and improves their daily lives. Researchers are also interested in how different factors, like a person's age or the specific type of cancer, might influence how well each treatment works.

Key takeaways

Tests if surgery (radical prostatectomy) helps prostate cancer with limited bone spread.
Compares surgery plus drug therapy to drug therapy alone.
Aims to improve survival, slow cancer growth, and enhance quality of life.
Study extended to 10 years for long-term results due to slow-growing nature of prostate cancer.
Eligibility includes men aged 18-75 with limited bone involvement.
Participation involves regular check-ups and assessments.

Who may be eligible?

This study is looking for men aged 18 to 75 who have been recently diagnosed with prostate cancer. The cancer needs to be at a stage where it's considered 'intermediate' or 'high-risk,' meaning it might be more aggressive, and it must be possible to remove it surgically. You also need to have between one and five spots of cancer visible on your bones from scans, but no spread to other major organs like the lungs or liver.

Your general health also plays a part. You should be in good physical shape, able to manage your daily activities without much difficulty, and not have too many other serious health problems. Your PSA level (a marker for prostate cancer) at diagnosis should not be too high.

There are also some reasons why you might not be able to join. For example, if surgery is too risky for you due to other health conditions, or if the cancer has spread to too many bones (more than five), or if it's in important organs. If you’re experiencing significant pain that requires strong opioid pain relief, you wouldn't be eligible for 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.

Are you a man aged between 18 and 75?
Do you have newly diagnosed prostate cancer?
Have scans shown between 1 and 5 spots of cancer on your bones, but not elsewhere in your organs?
Is your prostate cancer in a high-risk category, but also able to be surgically removed?
Are you generally well and coping with your daily activities without major issues (ECOG 0-1)?
Are there no medical reasons preventing you from having surgery (like other serious health problems)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you might receive either standard drug therapy for prostate cancer, or standard drug therapy plus radical prostatectomy surgery to remove your prostate gland. The treatment you receive will be decided by chance, like flipping a coin. You might also receive some additional chemotherapy early on, depending on your situation.

Your participation will involve regular check-ups and assessments over a long period. Initially, you might have closer follow-up, and the study has been extended to a total of 10 years of follow-up with two clinic visits per year to monitor your health and the cancer's progress closely. This is because prostate cancer can develop slowly, and a longer follow-up helps scientists understand the true long-term effects of the treatments. You will have scans and blood tests to track the cancer and your general health, and you'll be asked about your quality of life.

Potential risks and benefits

Taking part in a clinical trial offers the chance to receive close medical attention and potentially benefit from new treatment approaches that are not yet widely available. For some, adding surgery might improve cancer control and quality of life. However, surgery always carries risks, such as side effects from anaesthesia, bleeding, infection, and potential long-term issues like urinary problems or sexual dysfunction. There's also the chance that the new approach may not be better, or could even be worse, than standard treatment. You have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (1)

Markus Graefen
Verified postcode
Hamburg, Germany

Common questions

What is a 'Radical Prostatectomy'?

It's an operation to remove the prostate gland and sometimes nearby lymph nodes.

Why is this study important?

It's exploring if surgery can benefit men with prostate cancer that has spread a little, which isn't a standard treatment approach currently.

How long will the study last?

The study will now follow participants for a total of 10 years to see the long-term effects of the treatments.

Will I definitely get the surgery if I join?

No, whether you receive surgery or standard drug treatment will be decided by chance, like drawing lots.

Can I leave the study at any time?

Yes, you are free to leave the study at any point without it affecting your future healthcare.