Evaluation of Sleep Quality in Prostate Cancer Patients Undergoing Treatment With Hormonal Therapeutic Approaches and in Patients With Full-resected Early Breast Cancer

Prior treatment

• Any previous treatment with ADT or oral AR-targeted agent (exception for short course anti-androgens - disease flare)
• Have not received systemic treatment for any other cancer within the last 12 months
• Any clear contraindications present against treatment with ADT
• History of brain tumours, presence of brain metastases or previous cranial irradiation
• Diagnosis of insomnia and chronic intake of hypnotic medication at baseline
• Chronic intake of medications that are known to induce sleep disturbance (antihistamines of first generation, cortisone intake \> 25 mg/day)
• Previous chemotherapy at any time, in treatment with ET at not standard dosage
• Have received systemic treatment for any other cancer within the last 12 months
• History of brain tumours, presence of brain metastases or previous cranial irradiation
• Diagnosis of insomnia and chronic intake of hypnotic medication at baseline

Other illness

• Histology with predominant small cell prostate cancer
• Active secondary malignancy that requires systemic therapy
• Presence of sleep apnea syndrome, Apnea Hypopnea Index (AHI) \>15 at baseline
• Severe respiratory disorders (asthma, Chronic obstructive pulmonary disease) at baseline
• Severe cardiovascular disease or severe cardiovascular event \< 6 months
• History of stroke or other neurologic chronic illnesses \< 6 months
• Present diagnosis of depression or psychiatric illness pharmacologically treated
• Any diagnosed condition that causes known sleep disturbance
• Active secondary malignancy that requires systemic therapy
• Presence of sleep apnea syndrome, Apnea Hypopnea Index (AHI) \>15 at baseline
• Severe respiratory disorders (asthma, Chronic obstructive pulmonary disease) at baseline
• Severe cardiovascular disease or severe cardiovascular event \< 6 months
• History of stroke or other neurologic chronic illnesses \< 6 months
• Present diagnosis of depression or psychiatric illness pharmacologically treated
• Chronic intake of medications that are known to induce sleep disturbance (antihistamines of first generation, cortisone intake \> 25 mg/day) or any diagnosed condition that causes known sleep disturbance

Other

• Body mass index (BMI) \> 35 at baseline
• Have demonstrated impaired mental status
• Night shift workers
• Excessive lifestyle: massive coffee intake at night, regular excessive cigarette and alcohol consumption in the evening
• Unhealthy sleep hygiene
• Nocturia (the urgent need to urinate more than 2 times during the main sleep period at night) at baseline
• Non-epithelial BC or BC with mixed epithelial and non-epithelial histology
• Body mass index (BMI) \> 35 at baseline
• Have demonstrated impaired mental status
• Night shift workers
• Excessive lifestyle: massive coffee intake at night, regular excessive cigarette and alcohol consumption in the evening
• Unhealthy sleep hygiene
• Nocturia (the urgent need to urinate more than 2 times during the main sleep period at night) at baseline

• Written infor med consent according to International Conference on Harmonisation (ICH)/Good Clinical Practice (GCP) regulations before registration and prior to any trial specific procedures
• Histologically proven adenocarcinoma of the prostate
• Eastern Cooperative Oncology Group performance status 0-2
• Adult male patient \> 18 years of age, no upper age limit
• Localized prostate cancer, locally advanced hormone-sensitive prostate cancer (HSPC) or metastatic hormone-sensitive prostate cancer (mHSPC)
• ADT recipients are required to be scheduled to start ADT as standard of care (SOC) for metastatic or locally advanced prostate cancer
• Scheduled to receive ADT treatment as SOC for \> 6 months in combination with radiotherapy or oral AR-targeted systemic treatment as prescribed by the treating physician or radiotherapy alone
• Written informed consent according to International Conference on Harmonisation (ICH)/Good Clinical Practice (GCP) regulations before registration and prior to any trial specific procedures
• Women with full-resected early (stage I-III) epithelial BC, ductal carcinoma in situ or lobular carcinoma in situ, without evidence of residual disease
• Eastern Cooperative Oncology Group performance status 0-2
• Adult female patient ≥ 18 years of age, no upper age limit
• Proven postmenopausal status (defined by absence of menstruation for at least 6 months and/or level of estradiol \<40 pg/ml, or bilateral oophorectomy or ovarian irradiation for suppression of ovarian function)