PROSPEC study; PROstate cancer follow-up care in Secondary and Primary hEalth Care

Prostate cancer is the most common cancer in men in the Netherlands. In 2017,
11.000 men were diagnosed with prostate cancer. Approximately 80% of the men
are diagnosed with local or regional prostate cancer (the tumour is not
extended outside the prostate). Common treatments for men with localized
prostate cancer (T1c - cT3 N0M0) are a radical prostatectomy or radiotherapy.
Currently, in the Netherlands after initial treatment patients are included in
a specialist-based programme (at the specialist who performed the primary
treatment) where the principal elements of routine follow-up care are periodic
visits for history-taking and physical examination, and surveillance by testing
the prostate specific antigen (PSA). After primary treatment many prostate
cancer survivors experience late effects of treatment, including urinary and
bowel symptoms, sexual dysfunction, and adverse psychosocial and relationship
effects. Illness related uncertainty, including PSA anxiety, has also been
observed in a significant percentage of prostate cancer survivors.
To date, many publications indicate the need for improving the quality of
survivorship care. several studies have shown an increase in the use of primary
health care (PHC) among cancer survivors in comparison to patients without a
history of cancer. Although general practitioners (GPs) are often involved in
cancer survivorship, they have not played a formal role in prostate cancer
follow-up care. With the increasing number prostate cancer survivors, and with
the many competing demands on cancer specialists* time and resources, the need
to find alternative solutions for providing survivorship care for cancer
patients cannot be overstated. Although several studies suggest that GPs might
effectively take on the role of providing survivorship care to cancer
survivors, there is little empirical evidence available on optimising and
moving the focus of cancer follow-up from secondary to primary care.

We hypothesize that the follow-up and aftercare of prostate cancer in the
Netherlands can be led by the GP. We hypothesize that GP-led recurrence
detection programme leads to at least equal detection of recurrences as the
current follow-up in secondary care. Furthermore, we expect that better
involvement of the GP will result in higher quality of life, better continuity
of care, better preventative healthcare and counseling, and lower healthcare
costs. If demonstrated to be equal to or better than specialist-led follow-up
care, the possibility of providing GP-led prostate cancer survivorship care
will be a welcome solution for the growing problem of providing appropriate
follow-up services to the ever growing population of cancer survivors.

Multi-centre randomized controlled trial with a calculated total sample size of
390 patients. At the first follow-up visit at the hospital post-treatment, men
will be invited by their treating specialist to participate in the study.
Consenting patients will be randomized to GP-based or specialist-based (both
consisting of 195 patients) follow-up care. All patients will be followed
during a 2-year study period or until the development of a new primary cancer.

GP-based follow-up and aftercare for prostatecancer survivors

In both study groups (experiment and control group) the national guideline for
follow-up of prostate cancer will be used. It is hypothesized that the
adherence to the prostate cancer surveillance guideline will not differ
significantly between GP-led and specialist-led survivorship care.
Furthermore, we expect that better involvement of the GP will result in higher
quality of life, better continuity of care, better preventative healthcare and
counseling, and lower healthcare costs. In order to reduce possible risks,
information will be given to the GP about primary treatment, any complications,
subsequent treatment-related side effects, risk of recurrence, signs and
symptoms of recurrence and recommended steps and procedures in the case of
suspicion of recurrence. Also, an independent safety committee will evaluate
the primary and main secondary endpoint twice, after 50 and 150 patients have
finished the first three months of the intervention. In addition, all involved
physicians will be asked by the primary researcher to report any potential
adverse events caused by following the study protocol.
Finally, patients have to complete four questionnaires during the 2-year study
period. The questionnaires take about 30 minutes.