Prostate Biopsy Protocol in Active Surveillance for Prostate Cancer Causes ED. Con Man: Andrew McCullough May

Transcription

1 Prostate Biopsy Protocol in Active Surveillance for Prostate Cancer Causes ED Con Man: Andrew McCullough May

2 It may be particularly useful as an initial screening instrument in a general practice What is the SHIM? Published as a diagnostic test for ED in 1999 Does it capture whether setting you try or not? 3

3 Clinical Scenario Mr ED is 62 years old and has been married 40 years. He is sexually active weekly and uses PDE-5 inhibitor His PSA jumped from 1 to 4 and he had a biopsy a year ago showing Gleason grade 3+3 in 2 of 12 cores in less than 50% of the 2 cores. He joined the AS prospective protocol and filled out a SHIM before the biopsy His SHIM score was 21 (3,3,5,5,5) with Viagra and 12 (2,2,2,2,4) without. He assumed that he was supposed to answer with Viagra. He presents for his second biopsy and consents to a study about ED and prostate biopsy. He was never told before of the risk of ED with biopsy. He is puzzled. He is told that he needs to complete the SHIM at one week, one month and 3 months. He is to send them in by mail. He is confused since it asks for 4 week recall

4 Clinical Scenario He has hematospermia for 6 weeks and does not have sexual relations. He sends in his scores. SHIM drops to 5 and 5 (1,1,1,1,1) at one week and one month. His biopsy result shows more low grade small volume cancer. He stays on AS. Viagra is dropped from his health insurance. A script now costs 50$ a pill. His wife coaxes him into having sex. Depressed, he loses his erection during sex. At 3 months he completes the questionnaire again now his SHIM is 12 (3,3,2,2,2) off Viagra. He went from SHIM 21 to 5,5 and 12. What caused his ED? The biopsy? Depression? Lack of Viagra?

5 Clinical Scenario 2 years later he receives a questionnaire in the mail asking him to fill out a SHIM following up on erectile function after biopsy. He has had two further biopsies showing no stage migration Still on AS. He is no longer using Viagra and his partner has metastatic breast cancer she has vaginal dryness and has severe dypareunia. His masturbatory erections are marginal. He has not had sex in 3 months. He reads the SHIM asking for 4 week recall of his sexual experience and his SHIM is 9. (3,3,1,1,1) What caused his ED? The biopsy? Lack of Viagra? His wife s issue? It isn t always what it seems. Life can be anti-erectogenic?

6 Within the first 35 days Complications of Prostate Biopsy It ain t so benign Pain 43.6% Fever 17.5% Hematuria 6 5.8% Hematochezia 36.8% Hematospermia 92.6% At 7 days 20% would consider another biopsy a major or moderate problem Within first 35 days 10% sought medical care for the complications DerekJRosario BMJ:344 7

7 218 Prostate Biopsies 3 separate interviews with institutional non-validated questionnaire: Baseline, one week and one month Mean Age 65 Mean Number of Cores 8.3 Pre-biopsy ED 23% Preoperative anxiety 64% Anxiety associated with Bx ED 7% 15% of men without ED developed ED at one month 8

8 patients 0 No ED Mild ED Moderate ED Sever ED Pre Biopsy One Month Six months European Urology 53 ( )

9 European Urology 53 ( )

10 No ED Mild Moderate Severe Pre Biopsy 1 month 6 month UROLOGY 71: ,

11 Pre Biopsy 1 month 6 month Desire Orgasm Arousal Satisfaction UROLOGY 71: ,

12 UROLOGY 71: ,

13 Serial prostate biopsies are associated with an increased risk of erectile dysfunction in men with prostate cancer on active surveillance AS at Hopkins: Gleason score less than 7 PSA density less than 0.15 stage ct1c disease. Men older than 65 years Protocol for AS Annual 10 to 12-core prostate biopsy since 1998 Q 6 months DRE, PSA and free PSA At protocol entry patients complete a SHIM and I-PSS questionnaire. J Urology Vol. 182, , December

14 Outcome Measures; Retrospective review: 1) baseline SHIM and I-PSS data at protocol entry 2) medicine use, demographic information and co-morbidities 3) the number of biopsies each had undergone before and during participation in the EM protocol Only one questionnaire was sent to the men 78 men were excluded: 60 no SHIM score 18 were biopsied less than 6 weeks from the survey J Urology Vol. 182, , December

15 J Urology Vol. 182, , December

16 220 men At the time of biopsy men were given a five-item version of the International Index of Erectile Function (IIEF-5) Patients were then given these same questionnaires in self-addressed, stamped envelopes for completion at 1, 4 and 12 weeks after the biopsy, and returned to the clinic. 12 core biopsies 17

17 2014 BJU International 18

18 Are these findings clinically relevant? 2014 BJU International 19

19 Percent No significant Difference 0 Pre Biopsy One Month 3 months No ED Mild Mild to Moderate Severe

20 SHIM scores blend 2 distinct but related attributes, including 1) EF, a reflection of potency and physical ability, and 2) sexual activity status, a social and partner dependent attribute We decomposed SHIM scores into EF and sexual activity status, and analyzed these outcomes separately SHIM score is quite different depending on the distribution of sexual activity status in the sample. In 427 men with low risk Pca who provided a total of 1,398 evaluations of EF after up to 9 biopsies per man, we found no association between EF and increasing BX exposure after adjusting for age, sexual activity status, clinical stage and diagnostic period. 21

21 AUA White paper Erectile Dysfunction ED may be a transient complication of repeated PNB. However, it is difficult to separate out the actual effect of the biopsy from the surrounding anxiety and effects of aging Short-term ED may be a complication of TRUS-guided PNB. However, longterm ED is likely unrelated to the biopsy procedure itself, but rather associated with other factors such as advancing age, anxiety, comorbidities, or prostate cancer diagnosis and treatment. In summary, a non-negligible proportion of men undergoing biopsy experience ED; however, they usually return to baseline EF by 1 6 mo J Urol Mar 28. : S (17)

22 Summary Erectile function after prostate biopsy and AS is difficult to assess due to confounding factors Patient concerns with the side effects of the biopsy Patient fear about prostate cancer and his mortality The partner s fears and anxieties Co-morbidities and aging The inadequate tools that we have to measure ED We need hard objective data not soft circumstantial evidence 23

23 Does Prostate Biopsy Protocol in Active Surveillance for Prostate Cancer Causes ED? The jury is in! There is no smoking gun? The Jury is still out Not Guilty 24