THE "NEW" PROSTATE CANCER INFOLINK

Some of the most interesting data on the management of prostate cancer seem to be coming out of Australia in recent years — and the newly reported data from the ProCare trial is a case in point.

All advocates and many patients too will be well aware that treatment for prostate cancer is associated with risk for a whole series of potential side effects — and not just the physical ones like incontinence and sexual dysfunction, but also depression and other serious psychological issues that can affect both the patient and his family and his co-workers if he is still employed.

A new paper by Emery et al. in BJU International now gives us data from a randomized, Phase II, clinical trial of two different methods of follow-up for men after their initial treatment for prostate cancer (the ProCare trial). We are going to have to give a good deal of detail about this trial to explain it properly.

The trial enrolled a cohort of patients treated with either surgery or radiation therapy at six different centers in Victoria and Western Australia. Patients were enrolled in the trial only after their initial treatment (but within the ensuing 8 weeks). To be eligible the patients had to meet the following criteria:

• Able to read and write English
• Have a primary care physician who agreed to participate

The trial was not open to men who

• Had high-risk prostate cancer (clinical stage T3; PSA > 20 ng/ml, or a Gleason score > 8)
• Were on androgen deprivation therapy (ADT) after completion of radiotherapy
• Had metastatic disease or were being treated with palliative intent
• Had any type of severe cognitive or psychiatric disorder

Once a patient had agreed to participate in the trial (and his primary care physician had also agreed to participate), each patient was then randomized to one or other of two forms of follow-up care as described below:

• The “usual care” or control arm — in which the patient was scheduled for standard clinical care, with visits every 3 months to the treating (hospital-based) urologist or radiation oncology team, with relevant PSA tests, review of any symptoms, and clinical examination as necessary.
• The “shared care” or trial intervention arm, in which two of the routine hospital visits during the first 12 months of follow-up were replaced by visits to the patient’s primary care physician (at 6 and 9 months) and
  • An additional visit with the primary care physician was scheduled shortly after completion of treatment for the prostate cancer.
  • Structured systematic communication, using a survivorship care plan, was implemented.
  • Clinical management guidelines and local resources were provided for the primary care physician.
  • The patient and the primary care physician were prompted to ensure follow-up appointments.
  • A screening system for patient distress and other unmet needs was implemented, using a prostate cancer-specific problem checklist.
  • The patients were provided with informational resources about prostate cancer and treatment side effects.

Participating patients were asked to complete a set of five different questionnaires at different times during the course of their care and follow-up, and the physicians’ records were audited to ensure that patients were receiving the appropriate tests, getting appropriate medications as needed, etc.

Here are the core study findings:

• 172 patients were eligible for inclusion in the trial.
• 88 patients and their primary care physicians agreed to participate and were randomized to one or other trial arm.
  • 45 patients were randomized to the shared care arm.
  • 43 patients were randomized to the usual care or control arm.
• Two patients in the shared care arm and one primary care physician with a patient in the shared care arm withdrew from the study within 6 months of study initiation.
• There were no clinically important or statistically significant differences between groups with regard to distress, prostate cancer-specific quality of life, or satisfaction with care.
• There was high compliance with PSA monitoring in both groups.
• Two patients in the shared care group had clinical recurrence of their prostate cancer and were referred back to a specialist within 1 week of detection of the recurrence by the primary care physician.
• Patients in the shared care arm had a strong preference for shared care (63 percent) as compared to usual care.
• Patients in the usual care arm distributed their preferences between shared care (24 percent), follow-up with the treating specialist (34 percent), and follow-up with an available specialist (24 percent).

Now we need to be clear that there are things about Australia that make all treatment for serious clinical conditions challenging. Patients may have to travel several hundred or even thousands of miles to see a specialist. Therefore for those living in rural Australia, the convenience of being able to work with a relatively local primary care physician for follow-up after first-line treatment is extremely valuable. It may be less important to those living in or near a major city like Melbourne or Sydney or Perth. However, …

The ProCure trial certainly appears to be the very first randomized, controlled trial designed to test whether “shared care” for the post-treatment follow-up of men with low- to intermediate-risk prostate cancer is feasible and effective — and it appears to be so for many men. From the point of view of the Australian health care system, apparently it was also somewhat less costly.

From the perspective of The “New” Prostate Cancer InfoLink, the value of this trial is that it addresses the importance of prostate cancer patients being encouraged to reconnect with their primary care physician after treatment for prostate cancer, and the importance of education of primary care physicians being well informed about all of the potential side effects of treatment, most especially those like depression and the sens of “loss of manhood” that can affect so many men and their families. It makes more sense to us that a man may be able to open up about such problems to their primary care physician than to a specialized surgeon or radiation oncologist.

The “New” Prostate Cancer InfoLink (and Prostate Cancer International) would like to see a good deal more research into processes like this that can assist patients to receive high-quality, local care from physicians that is focused on a wide range of issues affecting full patient recovery after first-line treatment for prostate cancer — as opposed to just the outcomes of the initial treatments themselves.

Editorial note: The “New” Prostate Cancer InfoLink thanks John Wiley & Sons, Inc. (the publishers of BJU International) for the prompt provision of a full-test version of this article for our early review and comment.

Filed under: Living with Prostate Cancer, Management, Treatment | Tagged: care, outcome, planning, shared, survivorship |