Failed to act on the increase in her father’s PSA levels after they started to rise from April 2018 to May 2020 and his reports of back pain during this period 10. PSA is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in the blood and results are usually reported as nanograms of PSA per millilitre (ng/ml) of blood. The level of PSA is often elevated in people with prostate cancer, and the PSA test is used to monitor the progression of prostate cancer in men who have already been diagnosed with the disease.
11. There is no specific normal or abnormal level of PSA in the blood and PSA levels of 4.0 ng/ml and lower are considered normal. However, some individuals with PSA levels lower than 4.0 ng/ml have prostate cancer and many with higher PSA levels between 4 and 10 ng/ml do not have prostate cancer. In addition, various other factors can cause someone’s PSA level to fluctuate. For example, the PSA level tends to increase with age, prostate gland size, and inflammation or infection. In general:
• Below 4 ng/ml is considered typical for most people • 4 to 10 ng/ml is considered slightly elevated • 10 to 20 ng/ml is considered moderately elevated • 20+ ng/ml is considered highly elevated
12. Mr Q’s PSA level was 7.3 ng/ml when his cancer was diagnosed in 2010 and had lowered to 0.2 ng/ml in 2012 after treatment. Mr Q’s PSA level began to rise again and from 2018 and his six monthly tests reported the following levels:
• 17 April 2018 PSA 4.6 ng/ml of blood • 12 November 2018 PSA 6 ng/ml of blood • 24 April 2019 PSA 6.7 ng/ml of blood • 22 November 2019 PSA 8.4 ng/ml of blood • 21 May 2020 PSA 12.2 ng/ml of blood
13. Mrs F says the Trust failed to act on the increase in her father’s PSA levels after they started to rise in April 2018. The Trust continued to monitor his PSA level until 21 May 2020 when it reached 12.2 ng/ml. At this point the Trust decided to restart Mr Q’s hormone treatment (a treatment that slows or stops the growth of cancers that use hormones to grow, such as prostate cancer, by changing the body’s hormone levels or actions).
14. Mrs F says the increasing PSA levels and her father’s reports of back pain were signs his cancer had returned. She says if the Trust had acted on this and arranged appropriate investigations her father’s recurrent cancer could have been diagnosed and his hormone treatment restarted earlier.15. The NICE prostate cancer guidance recommends clinicians do not routinely offer hormonal treatment following a biochemical relapse (a rising level of PSA levels in prostate cancer patients who have already had treatment) unless the patient has symptoms of local disease progression, proven metastases (the spread of cancer cells to other parts of the body) or a PSA doubling time (the period it takes for the PSA level in the blood to double) of less than 3 months.
16. Mr Q’s PSA level had dropped to 0.2 ng/ml in 2012 following treatment. Our adviser said it is therefore reasonable to assume that when his PSA increased to 2.8 ng/ml on 3 April 2017 there was evidence to indicate a biochemical relapse. The records indicate the Trust continued to monitor Mr Q’s PSA level on an annual basis to establish when further hormone treatment should be provided.
17. The records indicate Mr Q reported experiencing back pain on 4 January 2018. The records state ‘no other problems noted apart from some lower back pain he feels is related to his building project he is currently undertaking’. The Trust recorded his back pain as mild and non-cancer related.
18. Mr Q’s PSA level increased to 4.6 ng/ml on 17 April 2018 and the Trust decided to increase the frequency of his PSA tests to every 6 months. Our adviser said this indicates the Trust considered his PSA level of 4.6 ng/ml to be of concern requiring more frequent monitoring.
19. From 10 May 2018 there was no further reference to back pain however Mr Q did report intermittent hip and knee pain, which our adviser said are unlikely places for bone metastases to occur. The records state ‘no complaints of pain except occasional hip and knee pain’. The records for this date also state ‘consider restarting hormones if PSA goes over 10 ng/ml’.
20. On 12 November 2018, 24 May 2019 and 22 November 2019, although there was a steady increase in his PSA level, there was no further mention of back pain and no mention of any new areas of concern. Our adviser said no symptoms are reported in the records for this period to suggest any indication of local disease progression or metastases. The Trust planned a hip replacement for Mr Q which our adviser said would support the view that his hip and knee pain was degenerative (where a part of the body becomes weaker and less able to function) rather than as a result of a spread of metastatic cancer.
21. The Trust recommended restarting hormone treatment only after Mr Q’s PSA had reached 12.2 ng/ml on 21 May 2020. Our adviser said based on the information in the records there is no evidence to indicate the Trust should have considered starting hormone treatment sooner than 21 May 2020 as Mr Q’s PSA doubling time was more than the 3 months recommended in the NICE prostate cancer guidance. Using the PSA doubling time calculator we calculated Mr Q’s PSA doubling time during this period at over 15 months.
22. Mrs F says the Trust did not carry out any additional investigations during this period and only monitored Mr Q’s PSA levels. Our adviser said this is a clinical judgement made by the Trust based on the evidence available to them at that particular time. There are no guidelines which advise at what point further investigations should be carried out and the NICE prostate cancer guidance does not give any specific recommendations regarding arranging investigations for patients who have a biochemical relapse after initial treatment.
23. Our adviser said the decision to continue to monitor Mr Q’s PSA at 6 monthly intervals can be supported by the information in the records. There is no evidence in the records to indicate the Trust should have requested further scans or investigations during this period as Mr Q did not display symptoms which may have indicated the possibility of local disease progression or metastases.
24. We carefully considered Mrs F’s complaint and the supporting information she has provided. We also considered the information in the records, the guidance and the advice we have received. We acknowledge Mrs F’s concerns about the increase in her father’s PSA levels during this time and the distress this caused.
25. We found the Trust acted in accordance with the NICE prostate cancer guidance after Mr Q’s PSA levels started to rise from April 2018 to May 2020. The plan of treatment for recurrent prostate cancer was to restart hormone treatment and we found no evidence in the records to indicate the Trust should have considered restarting hormone treatment prior to 21 May 2020.
Failed to provide adequate care or carry out the appropriate investigations from May 2020 and March 2021
26. Mrs F says even after his PSA increased to 12.2 ng/ml in May 2020 the Trust did not call her father in for tests, scans or for face-to-face consultations. She says her father also started to complain of back pain in May 2020 which continued throughout this period but was not investigated or acted upon by the Trust.
27. Mr Q was awaiting hip replacement surgery at this time and Mrs F says the Trust recommended he wait until after the hip replacement surgery had been completed before restarting treatment. Mrs F says the Trust put his hip replacement first when they should have been investigating for recurrent cancer. She says as her father’s back pain did not improve the Trust performed a scan in February 2021 which identified recurrent cancer in the base of his spine.
28. She says her father’s high PSA level and back pain were signs his cancer had returned and spread. She says if the Trust had acted on his symptoms and arranged appropriate investigations his recurrent cancer could have been diagnosed and treated sooner before it had the chance to spread.
29. In its response to this point the Trust said:
‘Your father contacted (the Trust) in June 2020, when his PSA had increased to 12.2 ng/ml. This should have prompted hormone treatment but at the time this was complicated by his planned admission for hip replacement surgery, which required him to isolate. (We) explained that it may be prudent to start this treatment after his surgery, in case he had any unwanted side effects from the medication. (We) understand Mr Q was aware that his PSA was rising and that this represented progression of his prostate cancer, he was also aware that at some point he would need to start treatment with hormone therapy which is why he phoned through his PSA result of 12.2 ng/ml.
Standard management of rising PSA in a patient without symptoms suggesting metastatic disease is to balance the toxicity of treatment with the effect of malignancy. A PSA of 10 ng/ml is often used as a point when treatment is instigated. If he had a scan prior to his investigations in 2021 it would probably have identified metastatic disease earlier but having hormone therapy earlier may have worsened rather than improved his quality of life with no benefit. Also if there had been concerning features related to his back pain, such as needing regular analgesia, waking him from sleep, associated neurology then imaging would have been arranged earlier.’
30. As we have set out in the previous point, arranging investigations for patients who have a biochemical relapse after initial treatment is a clinical judgement made by the treating clinician based on the evidence they have at that particular time. There are no guidelines which advise at what point further investigations should be carried out and the NICE prostate cancer guidance does not give any specific recommendations about this.
31. The records indicate Mr Q’s PSA level reached 12.2 ng/ml in May 2020 and the Trust made the decision to start hormone treatment with bicalutamide medication (an oral anti-androgen medication that blocks testosterone from attaching to cancer cells) on 2 June 2020, although there was a delay in coordinating the provision of this medication between the Trust and Mr Q’s GP. Mr Q had his hip replacement surgery and following a period of recovery the Trust changed his hormone treatment to LHRH injection (luteinizing hormone-releasing hormone injection, an intravenous treatment which stops the body from producing testosterone) in September 2020. The records indicate following treatment Mr Q’s PSA level reduced from 12.2 ng/ml in May 2020 to 10.4 ng/ml on 28 July 2020 and 7 ng/ml on 27 January 2021.
32. The records indicate Mr Q reported ‘back pain of low severity’ from August 2020, however it seems that this was not reported during the telephone conversations with the Trust on 13 August 2020, 5 January 2021 and 11 February 2021. Our adviser said they were unable to identify any evidence in the records for this period to indicate Mr Q suffered with significant back pain that would have prompted further investigations from the Trust.
33. Our adviser said given the reported low intensity of the back pain reported by Mr Q during this period, the absence of any new symptoms and the reduction of his PSA level after restarting hormone treatment, indicating it was having the desired effect, the Trust’s decision not to request any further investigations is clinically reasonable and can be supported by the information in the records.
34. The GMC guidance states when providing clinical care clinicians must ‘provide effective treatments based on the best available evidence’. We carefully considered Mrs F’s complaint and the supporting information she has provided. We also considered the information in the records, the guidance and the advice we have received. We acknowledge Mrs F’s concerns about her father’s reports of back pain during this period and the clinical decisions made by the Trust.
35. We found the Trust acted in accordance with the GMC guidance when considering the available evidence and deciding on the pathway of care and treatment to follow. We found no evidence to indicate the Trust failed to provide adequate care or carry out appropriate investigations during this period given Mr Q’s specific symptoms at this time and his response to the hormone treatment.
36. We acknowledge Mrs F’s views on the Trust allowing her father to undergo hip replacement surgery before providing LHRH injection hormone treatment. We also acknowledge the Trust’s explanation that the surgery was required to alleviate the pain and discomfort Mr Q was experiencing and improve his quality of life.
37. Hip replacement is a significant surgery and poses risks of its own. We found no evidence to indicate the decision of the Trust to provide Mr Q with bicalutamide medication and then change to LHRH injection after he had recovered from surgery to be inappropriate. The evidence in the records and the advice from our adviser indicates this approach was clinically reasonable and in line with the GMC guidance.
Failed to provide adequate care or carry out the appropriate investigations from March 2021 to August 2021
38. Mrs F says the Trust informed her father in March 2021 that a recurrence of his cancer had been found in the base of his spine and the Trust carried out further investigations throughout April 2021 to find out whether his cancer had spread to other areas of his body. She says the Trust informed her father in May 2021 that his cancer had also spread to his ribs and pelvis.
39. Mr Q’s condition deteriorated and he developed weakness, breathlessness, yellowing of his skin and loss of weight. He was admitted to hospital in late July 2021 and Mrs F says the Trust informed her father that his cancer was terminal before discharging him home on 17 August 2021. Mr Q sadly died on 2 September 2021.
40. Mrs F says the Trust missed the opportunity during this period to provide her father with care and treatment which may have prevented his cancer from becoming terminal as quickly as it did. She says if the Trust had arranged appropriate investigations and treatment after his recurrent cancer was identified in March 2021 it may have been treated before it became terminal and her father’s life may have been extended.
41. In its response to this point the Trust said:
‘Your father's GP referred him to oncology on 10 March 2021, with the results of his MRI scan, which had shown two small areas of disease. At that time, Mr Q was clinically stable with minimal symptoms. Mr Q was assessed as an outpatient on 29 March 2021. (The Trust doctor) needed to assess the extent of the disease via further scans and your father's cardiac function before a decision could be made to commence chemotherapy. Your father underwent an echocardiogram on 13 April 2021, a bone scan on 22 April 2021 and a CT scan on 27 April 2021.
These investigations were completed within a timely fashion, however, I recognise that any time taken in the context of cancer treatment can feel too long. (the Trust doctor) contacted your father on 5 May 2021 to discuss all the results of these investigations and it was agreed to proceed with chemotherapy. Chemotherapy treatment needs to be scheduled by the chemotherapy unit, and it is not uncommon for this to take up to three weeks.
(We) have reviewed these timings and would like to reassure you these were clinically appropriate and will not have adversely impacted his treatment. However, we understand the impact on Mr Q and his family and we are working hard to reduce the time taken to complete arrangements and commence chemotherapy/radiotherapy for our cancer patients.’
42. The records indicate Mr Q’s PSA level had dropped following treatment to 7 ng/ml in January 2021 but had increased again to 9.7 ng/ml in February 2021. Our adviser said this could suggest his cancer had started to progress again, however a second PSA test after an interval would be required to confirm this without evidence of any proven metastases or symptoms of local disease progression.
43. The MRI scan on 4 March 2021 was requested by Mr Q’s GP. The records indicate the GP believed Mr Q may be suffering spinal stenosis (a condition where spinal column narrows and compresses the spinal cord) due to his symptoms of fatigue and pains in his legs when he was active.
44. The report of the scan states abnormal changes were seen in the S1 (the upper, wider area of the triangular shaped sacrum) and L2 (the second vertebra of the lumbar section of the spine) of Mr Q’s spine which were suspicious for bone metastases. The report of the scan also describes degenerative changes throughout the lumbar and sacral regions of the spine. Our adviser said it was only after the MRI scan of 4 March 2021 that there was an indication the Trust needed to carry out further investigations and review his plan of treatment.
45. After reviewing the scan and his recent PSA test results the Trust held a telephone consultation with Mr Q on 29 March 2021. The records indicate the Trust arranged further investigations including an echocardiogram (a scan that uses sound waves to look at the heart and surrounding blood vessels), electrocardiogram (a test that records the electrical activity of the heart), bone scan, CT scan and blood tests.
46. The Trust changed Mr Q’s treatment plan to a trial with abiraterone (a type of hormone medication for advanced prostate cancer that has spread which stops the body producing testosterone) in combination with prednisolone (a similar medication designed to slow the growth of prostate cancer cells by decreasing testosterone production from the adrenal glands).
47. The records indicate the Trust started the trial with abiraterone and prednisolone on 26 May 2021, two months after Mr Q was diagnosed with metastases. Our adviser said it would not have been possible to start this treatment sooner as further investigations were requested which had to be carried out and reviewed prior to the change in treatment taking place.
48. Our adviser said even if the Trust had started the treatment immediately after the metastases were identified, there is no evidence to indicate it would have had any impact on Mr Q’s outcome. The records indicate the abiraterone treatment had to be stopped after six weeks as Mr Q developed progressive breathlessness and fatigue.
49. The records indicate Mr Q felt some improvement in his general wellbeing after stopping the abiraterone medication and the intention of the Trust was to change his treatment to prednisone and docetaxel (a medication designed to directly kill prostate cancer cells). However Mr Q’s condition deteriorated a week after the Trust stopped his abiraterone medication.
50. Our adviser said the records indicate his condition deteriorated quickly before a change in treatment could be implemented by the Trust. Our adviser said there is no evidence in the records to indicate this could have been foreseen by the Trust and sadly, by this point, Mr Q was no longer well enough to have any further cancer treatment.
51. We carefully considered Mrs F’s complaint and the supporting information she has provided. We also considered the information in the records, the guidance and the advice we have received. We acknowledge Mrs F’s concerns about the actions taken and treatment provided by the Trust.
52. We found the Trust acted in accordance with both the NICE prostate cancer guidance and the GMC guidance when assessing Mr Q’s condition and deciding on the pathway of care and treatment to follow during this period. We found no evidence to indicate the Trust missed an opportunity to provide additional or alternative treatment which may have improved Mr Q’s condition or outcome. We found no indication that the Trust should have carried out further investigations or revised the plan of treatment sooner.
Failed to provide her father with summary letters after his 6 monthly telephone consultations with his consultant
53. Mrs F says this led to her father and the family feeling uninformed about his condition, the progression of his cancer and his treatment options and plans. In its response to this point the Trust said a summary letter was sent to Mr Q and his GP following each of the consultations.
54. We have asked the Trust to provide a copy of the letters it sent to Mr Q after each of the 6 monthly consultations. The information the Trust has been able to send to us has only included the letters sent to his GP. Following further requests and discussion with the Trust it has been unable to provide copies of any correspondence to Mr Q.
55. We carefully considered Mrs F’s complaint and the information provided to us by the Trust. There is insufficient evidence to indicate the Trust sent summary letters to Mr Q after each of his 6 monthly consultations. On balance of probabilities, we found the Trust did not provide Mr Q with summary letters. We accept that this information would have helped inform the family about Mr Q’s condition, the progression of his cancer and his treatment options and plans.