Participants

The study commenced in December 2021 and concluded in December 2023. Initially, 113 men were screened for potential inclusion in the study. Of these, 15 were excluded due to a lack of consent to participate and a further 46 were excluded because they had received prior radiotherapy within the last 6 months or had undergone prior hormonal therapy. These exclusions were in place to ensure the study focused on the effects of the hormonal therapy being investigated without the influence of previous treatments. Therefore, 52 men of the original 113 men screened had data available at the initial assessment point, referred to as T0, were enrolled in the study.

At the T1 assessment (3 months after initiation of hormonal therapy), 44 participants remained evaluable and at the last assessment time point (T2, 6 months after initiation of hormonal therapy), 43 participants completed the study and had evaluable data at all three time points (T0, T1, and T2) (Fig. 1).

Fig. 1

Study flow-chart. T0 Baseline (before hormone therapy), T1 follow-up 1 (during hormone therapy, 3 months after treatment initiation), T2 follow-up 2 (during hormone therapy, 6 months after treatment initiation)

All 52 men in the study cohort were evaluated at T0. The median age at T0 was 67.5 (interquartile range [IQR] 58.0–73.0) years and the median time since diagnosis was 10.5 (IQR 3.8–38.0) months. All participants identified as heterosexual. The majority of patients were married (48 patients, 92.3%), with four patients being separated or widowed (3.8% each). All had children. In terms of occupation, 26 patients (50.0%) were actively employed, 25 patients (48.1%) were retired, and 1 patient (1.9%) was unemployed. In terms of prior treatment, 29 patients (55.8%) had not undergone surgery, and 23 patients (44.2%) had undergone a prostatectomy. All patients had undergone a prostatectomy at least 6 months before initiating ADT, reflecting the typical timeframe for disease progression. No patient was excluded from the study due to having undergone a radical prostatectomy (RP) within 6 months prior to baseline. This is consistent with the standard clinical practice of not routinely administering adjuvant ADT immediately after RP, whereas ADT is typically given concurrently with radiation therapy (RT). While recurrence can occur sooner, the majority of patients with localized prostate cancer experience recurrence after a period of 6 months or more following prostatectomy. Forty-two patients (80.8%) received hormone therapy alone, while the remainder received a combination of chemotherapy and hormone therapy (Table 1). Only nine out of 43 patients used medication for sexual function, and only one had a penile prosthesis. In this patient population undergoing ADT, we observed profound and concerning shifts across various facets of their QoL. These changes extended beyond the physical realm, significantly impacting their body image, sexual function, and emotional well-being. These changes in QoL, symptoms, and psychological distress over time are summarized in Table 2. Semi-structured interviews were conducted with patients at the three time points (T0, T1, T2); each interview was subsequently coded, and the frequencies of specific themes and responses are presented in Table 3.

Table 1 Baseline characteristics of the study population (N = 52)Table 2 Changes in quality of life, symptom burden, and psychological distress over time in patients with prostate cancer undergoing hormone therapyTable 3 Changes in coded interview responses related to psychosocial and sexual outcomes over time in patients undergoing hormonal oncological treatment for prostate cancerResults of the EORTC QLQ-C30 Scale

The EORTC QLQ-C30 assessment revealed a significant decline in the physical functioning scales over the duration of the assessment period, ranging from a score of 83.8 at baseline (T0) to 78.2 at 3 months (T1) and 76.7 at 6 months (T2) post-ADT initiation. Additionally, fatigue levels worsened from 23.7 at baseline to 34.3 and 35.2 at 3 and 6 months, respectively. Insomnia also increased notably from 23.7 at baseline to 31.8 at 3 months. Further, there were increases in nausea and vomiting (2.2–4.4), dyspnea (17.3–25.4), and diarrhea (3.8–12.7) at 6 months post ADH initiation compared to baseline, leading to an overall increase in symptom burden from 14 at baseline to 16.5 and 16.9 at 3 and 6 months, respectively. Notably, no significant changes were observed in QoL, role functioning, emotional well-being, cognitive abilities, social interaction, pain levels, appetite, constipation, or financial concerns.

Results of the QLQ-PR25 Scale

The results of the QLQ-PR25 assessment indicated a statistically significant worsening (p value < 0.05) in sexual functioning (SFU), with the score decreasing from an initial value of 59 at baseline (T0) to 34.4 after 3 months (T1) and further to 26.9 after 6 months (T2) post-ADT initiation. Similarly, sexual activity (SAC) decreased from 27.3 at baseline to 14.2 and 12 at 3 and 6 months, respectively. In parallel, there was an increase in overall increase in prostate cancer-specific QoL symptoms from 14.3 at baseline to 24.2 at 3 months and 28.2 at 6 months. Notably, no significant changes were observed in urinary symptoms, anxiety/depression, or bowel symptoms.

Semi-structured Interview Results

The semi-structured interviews, following the guidelines in Appendix 1 (ESM), captured specific “yes” or “no” responses from participants regarding their QoL across six key themes: body image, sexuality and intimacy, couple relationships, family dynamics, social sphere, and emotional well-being. Statistical analysis was then employed to identify significant changes in these responses over time (T0, T1, and T2), allowing us to track the evolving impact of ADT on patients’ lives.

Theme 1: Body Appearance

In terms of the results on patient’s perception of body appearance, those of greater statistically significance interest (p-value < 0.05) as reported in the semi-structured interviews included a worsening in their perception and body image at 3 (T1) and 6 (T2) months post-ADT initiation compared to baseline (T0), with feelings of being unattractive/not at all attractive (T0 vs. T1 vs. T2: 32.7% vs. 79.5% vs. 88.4%), unmasculine/not at all masculine (40.4% vs. 86.4% vs. 88.4%), and embarrassment (28.8% vs. 72.7% vs. 76.7%). These patients also reported other bodily transformations, such as overweight and fatigue (13.7% vs. 61.4% vs. 69.8%). The interviews did not reveal any significant issues related to body image perception prior to the onset of the oncological disease. Specifically, 88.5% of patients at T0, 84.1% at T1, and 86% at T2 did not report problems with the previous physical appearance of the tumor.

Theme 2: Sexuality and Intimacy as a Couple

Thirty-six patients (69.2%) expressed reluctance to discuss their sexuality due to concerns about judgment or stigma. Additionally, 29 patients (55.8%) felt their concerns were not adequately addressed by their physicians. In terms of results of greater statistically significant interest (p-value < 0.05), patients reported a worsening in their intimacy as a couple and sexuality at 3 months (T1) and 6 months (T2) post-ADT initiation compared to baseline (T0). In particular, they declared: little/no interest in sexuality (T0 vs. T1 vs. T2: 19.2% vs. 86.4% vs. 88.4%), little/not sexually active (48.1% vs. 95.5% vs. 97.7%), little/no pleasure (42.3% vs. 95.5% vs. 95.3%), discomfort (42.3% vs. 90.9% vs. 95.3%), erectile dysfunction problems (50.0% vs. 93.2% vs. 95.3%), and ejaculation problems (51.9% vs. 97.7% vs. 95.3%). Conversely, there were no significant changes over time in reports of problems in the domain of sexuality and intimacy as a couple that existed before the cancer diagnosis. At T0, 82.7% denied any such problems, compared to 79.5% at T1 and 72.1% at T2.

Theme 3: Couple Relationship

Despite the challenges associated with the illness and its treatment, the interviews revealed encouraging stability in several aspects of couples’ relationships. Importantly, the vast majority of couples (73.1% at T0) reported no pre-existing relationship problems. There were no significant differences at any time point in any of the aspects examined, including how couples communicated (78.8% at T0, 79.5% at T1, 74.4% at T2), whether they discussed the illness (80.8% at T0, 77.3% at T1, 72.1% at T2) or sexuality (67.3% at T0, 59.1% at T1, 60.5% at T2), and whether they felt closer (73.1% at T0, 72.7% at T1, 67.4% at T2) or more distant (84.6% at T0, 77.3% at T1, 72.1% at T2) from each other, or had previous problems (78.8% at T0, 72.7% at T1, 69.8% at T2). Nevertheless, the percentage of couples separating increased over time, from 15.4% at baseline (T0) to 22.7% at 3 months (T1) and 27.9% at 6 months (T2). The change between baseline and 6 months was statistically significant (p-value = 0.041).

Theme 4: Family Aspect

A significantly greater proportion of participants perceived changes in their family dynamics at 6 months post-ADT compared to baseline (83.7% vs. 50%, respectively), with a notable increase in feelings of dependence and reduced autonomy (from 26.9% at baseline to 50.0% and 48.8% at 3 and 6 months post ADT initiation, respectively). Nevertheless, the overall picture of family dynamics remained one of stability and resilience. The vast majority of patients reported a sense of closeness within their family following diagnosis (84.6% at baseline, 88.6% at 3 months, and 86.0% at 6 months), and the prevalence of pre-existing family problems remained consistently low (around 23–25%). The lack of statistically significant changes in these latter aspects (p-value = 0.999) further supports this interpretation.

Theme 5: Social Sphere

Interviews revealed a significant shift in the social sphere of some patients following ADT initiation. While only 26.9% reported changes in their social life at baseline (T0), this number increased to 72.7% at 3 months (T1) and 79.1% at 6 months (T2) post-diagnosis. Specifically, feelings of distance from their social reference group rose from 23.1% at baseline to 52.3% and 55.8% at T1 and T2, respectively. Additionally, a perceived loss of social role, often linked to leaving their jobs, was reported by 21.2% of patients at baseline, increasing to 40.9% at 3 months and 41.9% at 6 months post-ADT initiation. Nevertheless, there were no significant changes in how patients perceived their social group support over time (55.8% at T0, 40.9% at T1, 37.2% at T2).

Theme 6: Emotional Aspect

The results of the interviews highlighted significant changes in the emotional sphere of patients following ADT initiation. While no significant psychological problems were reported before the diagnosis (T0), a notable increase in patients reporting a change or worsening in their emotional state was observed 3 months after diagnosis from baseline (T1: 76.9–88.6%). This was particularly evident in the significant rise in reports of depressed mood from baseline to both 3 months (30.8–84.1%) and 6 months (88.4%) post-diagnosis. Additionally, the experience of anger worsened for some patients at the 3-month mark compared to baseline (21.2–40.9%). On a positive note, an improvement in the acceptance of the disease and treatment was seen at 3 months compared to baseline (80.8–97.7%). Finally, there were no significant changes in patients' overall emotional state (76.9% at T0, 88.6% at T1, 86.0% at T2) or in reports of emotional problems predating the cancer diagnosis (80.8% at T0, 75.0% at T1, 74.4% at T2).