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PIVOTALboost Trial

User
Posted 22 Feb 2021 at 21:49

I attended my outpatient appointment this afternoon expecting to register for The PACE Trial (Cyberknife) only to be told that I did not meet one of the criteria - my Stage T3a was too high.  Offered the opportunity to join the PIVOTALboost clinical trial instead!


PIVOTALboost provides additional radiotherapy to the lymph nodes outside of the 5mm margin of conventional radiotherapy.  My prostate cancer is at the edge of the prostate and does not appear, from the scans, to have spread outside but there is always the possibility it could have done so but can't be seen on the scans.


Does anyone have any experience off this particular trial they could share?


I was always concerned about the side effects that may (or may not) arise from radiotherapy and to accept the 'offer' of a greater level of radiotherapy sounds madness as the side effects are likely to be even worse.  However, I do realise its down to 'luck' as to whether you (1) get them in the first place, (2) the extent to which you get them; and (3) whether the computer randomly selects you for the trial!


I have also asked about using SpaceOAR and advised it would have to be a paid for service as I would not be eligible under NHS.  This could delay treatment as there is the lead-in time (awaiting info on this) and then a further two weeks before the radiotherapy planning session could be undertaken.  Onco wasn't that sure the SpaceOAR would be any advantage.  So is it worth it?


John


 

User
Posted 25 Feb 2021 at 16:23

I took part in a Phase 1/2 trial which was a pilot for the PIVOTALboost trial. I was diagnosed as T3b N0 M0 Gleason 4+3 in 2009. I had hormone therapy for about 12 months before starting RT in 2010. I had RT to the prostate 60Gy in 20 fractions and 47Gy to the lymph nodes also in 20 fractions i.e. the same as one of the treatments in the PIVOTALboost trial. I continued on hormone therapy for another two years making it a total of 3 years hormone therapy.


Unfortunately I now have biochemical recurrence but have not yet started any further treatment as my PSA doubling time is still about 3 years. I will have a PSMA PET/CT scan in May.


There is a summary of the results of the trial reported here. The full study publication concluded that "the safety data of hypofractionated schedules in the present study is encouraging, and the use of hypofractionated radiotherapy in a new trial, PIVOTALboost, is planned."


I enrolled in the study because I thought that IMRT which was not widely used at that time was better than standard external beam radiotherapy.  Everyone taking part had IMRT, but the number of treatments and the dose per treatment varied a bit between the groups.


Those of us in the trial who had 20 fractions rather than the standard 35-37 seemed to fare better in terms of lack of recurrence after 5 years.


I seem to remember I had some minor bowel and bladder problems but none that seriously inconvenienced me. I certainly have no regrets in taking part in the trial.

User
Posted 23 Feb 2021 at 01:30
I think whether or not SpaceOar is a) worthwhile and b) appropriate in your case depends rather a lot on where in your prostate the cancer is - if it is at the back (close to the bladder) then perhaps it isn't needed but on the other hand, if the cancer is at the side closest to the bowel, the SpaceOar could be ruled out if it would impede the radiotherapy from getting to the right bits. I don't think I would be worried too much by the potential delay while you explore it - you would presumably be on HT for a while anyway before the RT starts?

My understanding is that with PIVOTALBoost, the RT is often delivered over 15 or 20 fractions rather than 37 - higher dose over less fractions seems to cause fewer side effects. John had 20 sessions of 3.2Gy (or it might have been 3.0?) including the bottom of his bladder and had no side effects.
"Life can only be understood backwards; but it must be lived forwards." Soren Kierkegaard
User
Posted 23 Feb 2021 at 08:59

I was treated according to one of the PIVOTALboost trial arms because my onco thought it was my best option, but I wasn't treated on the trial.


Brachytherapy boost is where radiotherapy is provided as external beam, but boosted in the prostate (and seminal vesicles if appropriate) using brachytherapy.


PIVOTALboost is about providing evidence to show that HDR boost is (or isn't) a beneficial treatment over plain EBRT in high risk patients with no known lymph node spread. It's widely thought that it is beneficial, but there's no proper proof at the moment, and this is a randomised trial to provide this. The trial has many arms, because there are many variable parameters, including using classic EBRT.


The arm I was treated according to was tri-modal:


Hormone therapy, 18-36 months in total.


EBRT: 23 fractions of 2Gy (46Gy) to prostate, seminal vesicles, and pelvic lymph nodes (often incorrectly called whole pelvis or wide beam - it's not, it's accurately aimed at organs and pelvic lymph nodes).


HDR Brachytherapy 1 fraction of 15Gy to prostate only.


In spite of the differences in Gy, these two treatments are both half the dose they would be if done as monotherapies, so it's a half dose EBRT plus a half dose HDR Brachytherapy. Some of the trial arms adjust this ratio a bit.


I was told the half dose EBRT doesn't generally give any side effects, but bear in mind your rectum does get spill from both doses. I do have some minor rectal bleeding as a result, but in my case is painless and it has no impact on quality of life, and I don't regret my decision.


I was offered SpaceOAR on the NHS as part of the original NHS trial, but in discussion with my onco, we decided not to. As a high risk patient, there's a theoretical chance the spacer could push micromets out of the radiation field, allowing them to survive and cause recurrence. (The ICEMAN trial at UCLH is looking to get evidence on this, but it's closed now.)


You could ask to be treated according to one of the trial arms instead of on the trial. I was offered PIVOTALboost or this trial arm off-trial. My onco thought I might not get accepted on to PIVOTALboost because my hormone therapy had been messed up for 6 months, and in my case, also thought I should be doing one particular arm, not something you can control on the randomised trial.

Edited by member 23 Feb 2021 at 09:04  | Reason: Not specified

User
Posted 24 Feb 2021 at 21:08
EBRT is the umbrella term - external beam radiotherapy. IMRT and IGRT are just types of delivery - intensity modulated or image guided, but still EBRT.

I don't think the NHS guys would let you have SpaceOar if they didn't think you were suitable.
"Life can only be understood backwards; but it must be lived forwards." Soren Kierkegaard
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User
Posted 23 Feb 2021 at 01:30
I think whether or not SpaceOar is a) worthwhile and b) appropriate in your case depends rather a lot on where in your prostate the cancer is - if it is at the back (close to the bladder) then perhaps it isn't needed but on the other hand, if the cancer is at the side closest to the bowel, the SpaceOar could be ruled out if it would impede the radiotherapy from getting to the right bits. I don't think I would be worried too much by the potential delay while you explore it - you would presumably be on HT for a while anyway before the RT starts?

My understanding is that with PIVOTALBoost, the RT is often delivered over 15 or 20 fractions rather than 37 - higher dose over less fractions seems to cause fewer side effects. John had 20 sessions of 3.2Gy (or it might have been 3.0?) including the bottom of his bladder and had no side effects.
"Life can only be understood backwards; but it must be lived forwards." Soren Kierkegaard
User
Posted 23 Feb 2021 at 08:59

I was treated according to one of the PIVOTALboost trial arms because my onco thought it was my best option, but I wasn't treated on the trial.


Brachytherapy boost is where radiotherapy is provided as external beam, but boosted in the prostate (and seminal vesicles if appropriate) using brachytherapy.


PIVOTALboost is about providing evidence to show that HDR boost is (or isn't) a beneficial treatment over plain EBRT in high risk patients with no known lymph node spread. It's widely thought that it is beneficial, but there's no proper proof at the moment, and this is a randomised trial to provide this. The trial has many arms, because there are many variable parameters, including using classic EBRT.


The arm I was treated according to was tri-modal:


Hormone therapy, 18-36 months in total.


EBRT: 23 fractions of 2Gy (46Gy) to prostate, seminal vesicles, and pelvic lymph nodes (often incorrectly called whole pelvis or wide beam - it's not, it's accurately aimed at organs and pelvic lymph nodes).


HDR Brachytherapy 1 fraction of 15Gy to prostate only.


In spite of the differences in Gy, these two treatments are both half the dose they would be if done as monotherapies, so it's a half dose EBRT plus a half dose HDR Brachytherapy. Some of the trial arms adjust this ratio a bit.


I was told the half dose EBRT doesn't generally give any side effects, but bear in mind your rectum does get spill from both doses. I do have some minor rectal bleeding as a result, but in my case is painless and it has no impact on quality of life, and I don't regret my decision.


I was offered SpaceOAR on the NHS as part of the original NHS trial, but in discussion with my onco, we decided not to. As a high risk patient, there's a theoretical chance the spacer could push micromets out of the radiation field, allowing them to survive and cause recurrence. (The ICEMAN trial at UCLH is looking to get evidence on this, but it's closed now.)


You could ask to be treated according to one of the trial arms instead of on the trial. I was offered PIVOTALboost or this trial arm off-trial. My onco thought I might not get accepted on to PIVOTALboost because my hormone therapy had been messed up for 6 months, and in my case, also thought I should be doing one particular arm, not something you can control on the randomised trial.

Edited by member 23 Feb 2021 at 09:04  | Reason: Not specified

User
Posted 24 Feb 2021 at 19:53

Thanks Lyn and Andy, as always, very helpful.  The Trial literature states Prostate IMRT 60 Gray in 20 Fractions for 4 weeks OR Prostate & Pelvic IMRT 60 Grey in 20 Fractions for 4 weeks with the lymph nodes receiving a dose of 47 Gy in 20 Fractions at the same time the prostrate is treated.  Not sure how this relates to your experiences.


You refer to EBRT and HDR Brachytherapy, which I assume is different to IMRT, though I have no idea how or why!


As for where my cancer is located in relation to the bowel, all I know is right anterior <1%; right mid 10%; right posterior 20%; left anterior 70%; left mid 10%; left posterior 5% and mid central 10%.  All 3+4=7 except left anterior and mid central which are 4+3=7.  PSA at time 25, now (after 3 months hormone therapy) 4.3.


I have now been advised I can have SpaceOAR on NHS as part of the trial, so I assume it would be worth going for but slightly concerned Andy says some parts might get missed!


Any further thoughts would be much appreciated.  Many thanks. John

User
Posted 24 Feb 2021 at 21:08
EBRT is the umbrella term - external beam radiotherapy. IMRT and IGRT are just types of delivery - intensity modulated or image guided, but still EBRT.

I don't think the NHS guys would let you have SpaceOar if they didn't think you were suitable.
"Life can only be understood backwards; but it must be lived forwards." Soren Kierkegaard
User
Posted 25 Feb 2021 at 16:23

I took part in a Phase 1/2 trial which was a pilot for the PIVOTALboost trial. I was diagnosed as T3b N0 M0 Gleason 4+3 in 2009. I had hormone therapy for about 12 months before starting RT in 2010. I had RT to the prostate 60Gy in 20 fractions and 47Gy to the lymph nodes also in 20 fractions i.e. the same as one of the treatments in the PIVOTALboost trial. I continued on hormone therapy for another two years making it a total of 3 years hormone therapy.


Unfortunately I now have biochemical recurrence but have not yet started any further treatment as my PSA doubling time is still about 3 years. I will have a PSMA PET/CT scan in May.


There is a summary of the results of the trial reported here. The full study publication concluded that "the safety data of hypofractionated schedules in the present study is encouraging, and the use of hypofractionated radiotherapy in a new trial, PIVOTALboost, is planned."


I enrolled in the study because I thought that IMRT which was not widely used at that time was better than standard external beam radiotherapy.  Everyone taking part had IMRT, but the number of treatments and the dose per treatment varied a bit between the groups.


Those of us in the trial who had 20 fractions rather than the standard 35-37 seemed to fare better in terms of lack of recurrence after 5 years.


I seem to remember I had some minor bowel and bladder problems but none that seriously inconvenienced me. I certainly have no regrets in taking part in the trial.

User
Posted 26 Feb 2021 at 17:50

Thanks everyone for he feedback; most helpful.  I decided to opt in for the trial and to push for the SpaceOAR to be fitted.  On my last visit the Research Coordinator completed the medical questionnaire and took bloods to get an up to date PSA level and various other readings!  She sent me the results the next day and my PSA had gone down (from 25) to 4.3 as a result of the hormone therapy, which is brilliant news!


My hospital has confirmed they will fit SpaceOAR on the NHS and this has been provisionally booked for 17 March 2021 (apparently a ten minute procedure under local anaesthetic).  I went in today to sign trial consent form and complete the lifestyle questionnaire.  The Research Coordinator phoned me later that afternoon to advise that the computer randomisation had put me in the standard treatment Prostate only IMRT group (not the Prostate and lymph node IMRT group)!!  Oh well!

User
Posted 27 Feb 2021 at 10:13


John, it's really important that you are having the treatment you want, and you are under no obligation to go forward with the trial if that's not what you wanted. If you're not completely sure, speak with your oncologist.

 
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