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ProtecT Study - first main results 2016

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User
Posted 21 Sep 2016 at 16:48

The first main results from the ProtecT Study which was open to men with localised prostate cancer were published last week. A number of papers and articles are available which provide details and opinions of the findings from this 10 year study. The first main results from the study team have been published in a rather unusual way in that there are two papers by the research clinicians which set out their findings on separate parts of the study. One paper covers the “10-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer” and the other covers “Patient-Reported Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer”.

These first main results will be followed up for at least the next 5 years. The purpose is to find out how the level of survival for men in the monitored category compares with the level of survival outcomes for men in the surgery and RT categories.    

It is early days so the intention of this note is simply to pull together the information published by those involved with the study and those with an interest. I have not commented on any of the conclusions from the study. I have included links in this note so anyone interested can read the clinical findings from the study and a number of opinions and comments available so far. They can then take a view of all of this and how the findings may affect treatment options. Links 1 to 3 are from the study group with a further clinical appraisal at Link 4. Links 5 to 8 are non clinical opinions about the results of the study.   

1.  The starting point to this note is the Newsletter from the study team at Link 1 which outlines the first main outcomes from the study.

The first bullet point concludes that there were very few deaths in the three groups, that is, active monitoring (or surveillance if you like), radiotherapy, with ADT and surgery.

The second bullet point shows that twice as many men on active monitoring had cancer progression or spread than in the men in the surgery and radiotherapy groups and continues in saying that “The numbers are important”.

The third bullet point is about side effects and it is reported, amongst other things,  that half of the active monitoring group switched to either surgery or radiotherapy by the end of the 10 year follow up.

 I don’t think the ”Conclusion” section provides a lot that is new but it puts the various treatment options and expected results into perspective so that treatment decisions can, perhaps, be made with more certainty than before. 

Link 1: “ProtecT trial – first main outcome results published”

http://www.bris.ac.uk/media-library/sites/social-community-medicine/documents/protect/ProtecT%20Newsletter%20Autumn%202016%20number%2014%20Final.pdf 

2. The clinical outcomes from the study as explained in the Newsletter in Link 1 are in Link 2.

Link 2:  “10-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer” 

http://www.nejm.org/doi/full/10.1056/NEJMoa1606220 

 

3.  The patient reported outcome from the study are in Link 3.

Link 3:  “Patient-Reported Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer”

http://www.nejm.org/doi/pdf/10.NEJMoa1606221   

 

4.  An interesting clinical appraisal of the study from a clinician, who I understand was not a member of the study team, is in Link.4.

Link 4:  “Treatment or Monitoring for Early Prostate Cancer”

http://www.nejm.org/doi/full/10.1056/NEJMe1610395  

 

5. An analysis of the of the results from the study has been made for NHS Choices and is at Link 5.

Link 5:  "Invasive early prostate cancer treatments not aLways needed" 

http://www.nhs.uk/news/2016/09September/Pages/invasive-early-prostate-cancer-treatments-not-always-needed.aspx  

 

6. A "News and Views" article from PCUK is at Link 6.

Link 6: "Long term study shows active surveillance offers the same 10 year survival rate as radiotherapy and surgery" 

http://prostatecanceruk.org/about-us/news-and-views  

 

7   A couple of press articles are at Links 7 and 8 

Link 7:  http://www.telegraph.co.uk/news/2016/09/14/prostate-cancer-survival-rates-equally-high-if-you-monitor-disea/

 

Link 8:   https://www.theguardian.com/society/2016/sep/14/monitoring-prostate-cancer-effective-treatment

 

Only time will tell just how helpful the study results are for men to reach the best decision on the treatment options which may be available to them.

I hope this note is useful.

Alan

 

Edited by moderator 06 Jul 2023 at 13:16  | Reason: Not specified

User
Posted 21 Sep 2016 at 16:48

The first main results from the ProtecT Study which was open to men with localised prostate cancer were published last week. A number of papers and articles are available which provide details and opinions of the findings from this 10 year study. The first main results from the study team have been published in a rather unusual way in that there are two papers by the research clinicians which set out their findings on separate parts of the study. One paper covers the “10-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer” and the other covers “Patient-Reported Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer”.

These first main results will be followed up for at least the next 5 years. The purpose is to find out how the level of survival for men in the monitored category compares with the level of survival outcomes for men in the surgery and RT categories.    

It is early days so the intention of this note is simply to pull together the information published by those involved with the study and those with an interest. I have not commented on any of the conclusions from the study. I have included links in this note so anyone interested can read the clinical findings from the study and a number of opinions and comments available so far. They can then take a view of all of this and how the findings may affect treatment options. Links 1 to 3 are from the study group with a further clinical appraisal at Link 4. Links 5 to 8 are non clinical opinions about the results of the study.   

1.  The starting point to this note is the Newsletter from the study team at Link 1 which outlines the first main outcomes from the study.

The first bullet point concludes that there were very few deaths in the three groups, that is, active monitoring (or surveillance if you like), radiotherapy, with ADT and surgery.

The second bullet point shows that twice as many men on active monitoring had cancer progression or spread than in the men in the surgery and radiotherapy groups and continues in saying that “The numbers are important”.

The third bullet point is about side effects and it is reported, amongst other things,  that half of the active monitoring group switched to either surgery or radiotherapy by the end of the 10 year follow up.

 I don’t think the ”Conclusion” section provides a lot that is new but it puts the various treatment options and expected results into perspective so that treatment decisions can, perhaps, be made with more certainty than before. 

Link 1: “ProtecT trial – first main outcome results published”

http://www.bris.ac.uk/media-library/sites/social-community-medicine/documents/protect/ProtecT%20Newsletter%20Autumn%202016%20number%2014%20Final.pdf 

2. The clinical outcomes from the study as explained in the Newsletter in Link 1 are in Link 2.

Link 2:  “10-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer” 

http://www.nejm.org/doi/full/10.1056/NEJMoa1606220 

 

3.  The patient reported outcome from the study are in Link 3.

Link 3:  “Patient-Reported Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer”

http://www.nejm.org/doi/pdf/10.NEJMoa1606221   

 

4.  An interesting clinical appraisal of the study from a clinician, who I understand was not a member of the study team, is in Link.4.

Link 4:  “Treatment or Monitoring for Early Prostate Cancer”

http://www.nejm.org/doi/full/10.1056/NEJMe1610395  

 

5. An analysis of the of the results from the study has been made for NHS Choices and is at Link 5.

Link 5:  "Invasive early prostate cancer treatments not aLways needed" 

http://www.nhs.uk/news/2016/09September/Pages/invasive-early-prostate-cancer-treatments-not-always-needed.aspx  

 

6. A "News and Views" article from PCUK is at Link 6.

Link 6: "Long term study shows active surveillance offers the same 10 year survival rate as radiotherapy and surgery" 

http://prostatecanceruk.org/about-us/news-and-views  

 

7   A couple of press articles are at Links 7 and 8 

Link 7:  http://www.telegraph.co.uk/news/2016/09/14/prostate-cancer-survival-rates-equally-high-if-you-monitor-disea/

 

Link 8:   https://www.theguardian.com/society/2016/sep/14/monitoring-prostate-cancer-effective-treatment

 

Only time will tell just how helpful the study results are for men to reach the best decision on the treatment options which may be available to them.

I hope this note is useful.

Alan

 

Edited by moderator 06 Jul 2023 at 13:16  | Reason: Not specified

User
Posted 21 Sep 2016 at 19:51

Awesome post Alan
Many thanks. Too late now mind. Thanks for compiling this

User
Posted 21 Sep 2016 at 20:37

As usual Alan, an excellent post pulling together findings like this. Thank you very much. It will be interesting to learn in the next 5-10 years whether differences found in the groups of men shows become more marked. Perhaps of surprise to some will be how RT + HT has moved on to compare well with surgery but perhaps less surprisingly, spread found less significant in the treated groups than men monitored by AS.

Barry
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User
Posted 21 Sep 2016 at 17:49

Hi Alan,

It seems to me that there is an elephant in the room, a question begging to be asked, and that is how many of us who have had radical treatment, be it RP or RT, over the last ten years would still be here, just as healthy as we are, if we had not been treated?

How many of us have needlessly suffered side effects of treatment?

I for one am wondering how things would have turned out if I had not been treated?

:)

Dave  

User
Posted 21 Sep 2016 at 19:51

Awesome post Alan
Many thanks. Too late now mind. Thanks for compiling this

User
Posted 21 Sep 2016 at 20:37

As usual Alan, an excellent post pulling together findings like this. Thank you very much. It will be interesting to learn in the next 5-10 years whether differences found in the groups of men shows become more marked. Perhaps of surprise to some will be how RT + HT has moved on to compare well with surgery but perhaps less surprisingly, spread found less significant in the treated groups than men monitored by AS.

Barry
 
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