Study participants
’, psychiatric, prostate cancer2, disease stage
DISEASE PROGRESSION, PROSTATE CANCER, METASTATIC DISEASE, PROSTATE
The trial is recruiting men with a diagnosis of prostate cancer, of localised or advanced stage, who are currently receiving ADT and intended to receive a minimum of 6 months of further continuous treatment. Participants may have had potentially curative treatments (including, but not limited to, radiotherapy, brachytherapy, or surgery), with a minimum of 4 weeks between the final fraction/treatment/dose and registration into the trial. Participants must be experiencing problematic HFNS symptoms, defined as a score of 2 or more, on the HFNS rating scale, and willing to attend group workshops (virtual or face-to-face). The full eligibility criteria are listed in Table Inclusion and exclusion criteria1. A diagnosis of prostate cancer2. Localised or advanced disease stage. Patients may have had potentially curative treatments including, but not limited to, radiotherapy, brachytherapy, or surgery3. Currently receiving ADT and anticipated to require a minimum of 6 months further continuous treatment at the point of registration into the trial. Treatment may have been planned for either a fixed duration (for example, but not limited to, 2 years after radiotherapy) or permanent. Treatment may be with either adjuvant (following potentially curative treatment) or palliative intent. LHRH analogues, LHRH antagonists and surgical castration are all acceptable forms of androgen deprivation. Androgen receptor antagonists, including, but not limited to, bicalutamide, enzalutamide, apalutamide or darolutamide or abiraterone, may be given in combination with androgen deprivation according to local practice4. Presence of problematic HFNS symptoms defined as a HFNS rating scale score of two or more5. Ability to read and understand English without assistance6. 16 years or older7. Ability to attend virtual (or face-to-face) group workshops through video conferencing software. If this is not feasible, participants must be able to participate in one-to-one workshops by telephone8. Currently with uncontrolled biochemical, radiological or clinical disease progression or relapse if this would be anticipated to interfere with trial participation as determined by the local principal investigator or co-investigator9. Currently receiving chemotherapy. Prior chemotherapy must have been completed with a minimum of 4 weeks elapsed between the date of the final dose and confirmation of eligibility. Concomitant use of bone health agents, including zoledronate and denosumab is allowed10. Currently receiving radical multi-fraction external beam radiotherapy or brachytherapy These must have been completed with a minimum of 4 weeks elapsed between the date of the final fraction/treatment and confirmation of eligibility. Single fraction radiotherapy to sites of painful bony metastatic disease or ‘STAMPEDE style’ palliative prostate radiotherapy is allowed11. Intention to receive ADT on an intermittent schedule12. Use of experimental drugs within other interventional clinical trials. Co-recruitment to observational studies, or studies of surgery or focal ablation techniques where the interventional component is complete, is acceptable13. Currently receiving androgen deprivation as a neoadjuvant treatment14. Medical or psychiatric conditions or other factors that, in the view of the local PI, are likely to impact on the ability of the patient to participate in the trial procedures and interventions