No matter the best intentions of early intervention for this vulnerable group, we found it impossible to recruit the number of newly diagnosed patients with PC referred to radiotherapy and androgen deprivation therapy as planned. The inclusion rate of 38% was not lower than other randomised trials targeting sexual problems (20, 21), but patients available in this single study site were too few according to the time frame and intervention planned. The inclusion period was defined based on expectations of recruitment of at least four patients every month (Fig. 1). Based on five months of inclusion, we learned that a multi-centre study was needed. However, multi-centre studies require expertise in many centres and a much larger resource allocation.
Major obstacles for recruitment was patients’ not being sexually active or that they declined participation for other reasons, i.e. logistical challenges, before receiving the thorough written and oral information on the study. As such, they did not even appear on the screening list. Another major obstacle for recruitment was the concurrent inclusion of patients in the multicenter Scandinavian SPCG-15 trial randomising patients with locally advanced PC to radiotherapy or prostatectomy (22). This was prioritised over the ProCaRe trial, and therefore patients were primarily screened for the SPCG-15 trial. Inclusion in ProCaRe could potentially affect the quality of life measurements of the SPCG-15 trial study; therefore, inclusion in both trials was not feasible. On the other hand, patients planned for radiotherapy after declining participation in the SPCG trial were offered inclusion in ProCaRe. However, at the initial visit patients’ and partners’ only concern was the treatment of cancer. They did not have any mental surplus concerning sexuality, aligned with a recent study showing that the most preferable time for sexual rehabilitation is three months past treatment (23).
We involved patients and partners of the target group when co-designing the intervention using a focus group with five former patients with PC and four female partners. They were excited about the intervention, and as one man said: “I would have hoped that I had this opportunity”. However, they may have forgotten own prioritizations and thereby introduced recall bias.
We expected ProCaRe to study the effects of a health care model combining sexual advice, VED, and physical exercising on improving sexual well-being. However, sufficient study enrollment was not feasible, and the study was closed. This finding was in line with Karlsen et al., who had a recruitment rate as low as 14% in a population of prostate patients and partners offered sexual rehabilitation after prostatectomy (21). A more thorough pilot phase of the study might have resulted in critical knowledge and sufficient redesign of the study. We hypothesise that the primary problem of the program was timing, not the combination of the different elements: sexual advice, VED, and physical exercises in groups and at home.
In conclusion, sexual rehabilitation for patients with PC referred to radiotherapy and androgen deprivation therapy was not feasible as pre-habilitation, because patients were too impervious for dealing with sexuality so close to diagnosis, and the study was not prioritised. Sexual rehabilitation has to be timely delivered when the prostate cancer patient and partner are ready for intervention, and patients and partners in the co-design have to be representative of the target group. We believe that a later intervention in the cancer trajectory may be more appropriate.