THE "NEW" PROSTATE CANCER INFOLINK

Over the years, we have been asked several times whether there is a role for any type of  immediate treatment in men with a high level of concern for their risk of prostate cancer — despite a negative finding on prostate biopsy.

We have always answered this question by saying two things:

• We knew of very small numbers of patients with a serious family history of prostate cancer who had been treated in this way by small numbers of surgeons.
• We were also aware of published data from a small series of patients treated surgically for severe, chronic prostatis, whose symptoms appeared to have been largely resolved by their treatment at 1 year of follow-up.

Now we have a report from Taiwan that gives a retrospective analysis of all the available data from a series of 55 men, most of whom were negative for prostate cancer on biopsy, but who were sufficiently concerned about their risk that they went ahead and had prophylactic robot-assisted laparoscopic surgery (RALP) anyway.

The paper by Ou et al. has just been published in Anticancer Research and marks an interesting step in the evolution of the discussion about when and in whom such prophylactic treatment is either appropriate or necessary. And we should be clear that we have read the entire text of this paper prior to commenting.

Ou and his colleagues clearly have significant experience in the conduct of RALP. The 55 patients in question come from a total series of 1,060 patients, all operated on by the same surgeon (Dr. Ou) between 2005 and 2015. The first of the 55 men to receive a prophylactic, nerve-sparing RALP was operated on in 2012 after Dr. Ou had already conducted 365 prior RALPs.

In every case, there was also, clearly, a thoughtful decision process about the surgery:

• The majority of the patients had had a negative, TRUS-guided prostate biopsy (see below).
• All patients were followed for a minimum of 6 months after that initial negative biopsy and before any decision about the surgery.
• Follow-up in the period prior to surgery included repeat biopsies, MRI studies, and repeat PSA testing.
• Patients and their family members were invited to a group education course conducted by the lead author where they were clearly advised about the potential side effects and complications of RALP.
• The research team seems to have gone out of their way to ensure that all patients and relevant family members were fully aware of the possibility that the patient might well be found to have no prostate cancer in the pathological specimen post-surgery.

In addition, Ou and his colleagues ensured that they collected an enormous amount of detailed data on these patients, their actual operations, and their outcomes. They also carefully point out that a limitation of their study is that all data were collected prospectively, but analyzed retrospectively.

So let’s start with the presurgical data:

• 13/55 men (including two physicians) had refused to have a biopsy at all.
• 42/55 men had between one and four biopsies prior to their surgery.
• 41/55 men had agreed to have a 3-T, multiparametric MRI scan (which they had to pay for themselves; this was not a funded clinical trial) evaluated according to PI-RADs criteria.
• The patients’ average (mean) PSA level prior to surgery was 16 ± 2 ng/ml.
• Other data collected included the patients’ ages, BMIs, PSA levels, PSA densities, symptom and quality of life scores, DRE findings, etc.

All such data are carefully reported by Ou et al., along with such things as length of time of surgery, blood loss during surgery, and other factors.

So what were the immediate outcomes?

• All patients were successfully treated with a bilateral nerve-sparing procedure.
• Two patients had intraoperative complications (one of which involved a minor bladder injury and repair).
• 22/55 patients (40 percent) were found to have prostate cancer (including 5/13 patients who had refused to have a biopsy at all).
• 18/55 patients (33 percent) were found to have other prostate abnormalities such as prostatic intraepethelial neoplasia (PIN) or atypical small acinar proliferation (ASAP)
• 15/55 patients (27 percent) had benign disease (inclusive of men with nodular hyperplasia and/or inflammation of the prostate).

The paper also provides detailed information on the pathological findings for the 22 patients who were found to have prostate cancer, as follows:

• Pathogical staging included T2a (n = 6), T2b (n = 7), T2c (n = 2), T3a (n = 6), and T3b (n = 1).
• Gleason scores included Gleason 5 (n = 3), Gleason 6 (n = 9), Gleason 7 (n = 7), and Gleason 8 (n = 3).
• 4/22 patients (18 percent) had positive surgical margins.
• 5/22 patients (23 percent) had perineural invasion.
• No patients had lymph-node-positive disease.

In addition, in looking at the entire set of 55 patients:

• The post-surgical continence rate was 100 percent.
• Average (mean) time to recovery of continence was 11 days (range 0 to 28 days) after removal of the urinary catheter.
• Other data show clear improvements, on average, in the patients’ urinary function and quality of life scores.

No data are provided about the patients’ sexual function before or after their surgeries in the original paper, but please see the additional note at the foot of this page.

Dr Ou and his colleagues conclude that:

Prophylactic [RALP] with bilateral [neurovascular bundle] preservation is safe for patients with suspicion of [prostate cancer] when peformed by experienced surgeons. Postoperatively, [RALP] improves urinary function and [quality of life].

The “New” Prostate Cancer InfoLink does not feel it is appropriate for us to comment on the question of whether patients should or should not actually consider prophylactic radical prostatectomy (or any other form of prophylactic treatment) for unproven prostate cancer. This is a very highly personal decision. As the authors note, the first patient on whom they carried out such a procedure was a man with a significant familial history of prostate cancer.

Conversely, however, Ou and his calleagues have now given us some very clear documentation of how they went about the conduct of such procedures; the outcomes that any such patients might reasonably be able to expect at a suitably experienced surgical center; and the ways in which they documented the pre-surgical and post-surgical evaluation of such patients. For this, future potential patient (and the surgeons who may be willing to conduct such procedures) should be extremely grateful.

And one last thought. If any patient is considering the idea of having a prophylactic radical prostatectomy (or any other form of prophylactic treatment) for suspicion of an unproven prostate cancer, he would be wise to make very sure that he is talking about this with a treatment team that is at least as experienced as the one reporting these data, and which takes the same level of care to ensure a complete understanding — on the part of the patient and his family — of the risks involved.

Editorial notes: The “New” Prostate Cancer InfoLink thanks Dr. Yen-Chuan Ou of the National Yang-Ming University in Taipei, Taiwan, for promptly providing us with a copy of the full text of this important paper.

The lead author of the paper has also advised us — in a separate note — that, at 12 months after surgery, among 36 of the 55 patients who were potent prior to their surgery, potency (i.e., an erection sufficient for intercourse) was achieved by 32/36 men (88.9 percent) either with (n = 9) or without (n = 27) the use of phosphodiesterase type-5 inhibitors (i.e., drugs like Viagra and Cialis). These data are based on patient assessments using the International Index of Erectile Function (IIEF) scale, both preoperatively and postoperatively.

Filed under: Diagnosis, Management, Risk, Treatment | Tagged: outcome, prophylactic, RALP, risk, surgery |