Prostate Cancer, Prostate Cancer (Adenocarcinoma), Prostate Cancer (Diagnosis), Prostate Cancer Metastatic, Prostate Cancer Patients Treated by Radiotherapy, Prostate Cancer (Post Prostatectomy)
Conditions
Keywords
oncology, patient outcome, Prostate Cancer, Prostate Cancer in Algerian patients, Observational Study, Retrospective data, Treatment strategies, Diagnostic approaches, Clinical characteristics, Epidemiological data, Demographic data, Cross-sectional study, Real-world data, Algeria, Algerian Study
Brief summary
The goal of this observational study is to describe the demographic, epidemiological, clinical, and outcome characteristics of patients with prostate cancer. It also aims to analyze the diagnostic approaches and management strategies used in the care of these patients in Algeria.
Detailed description
This is a descriptive, cross-sectional clinical study including patients with histologically and/or biologically confirmed prostate cancer who are being followed in the participating centers. This study planned to enroll 500 patients. Data will be collected from medical records and structured patient interviews (≈30 minutes). A standardized electronic case report form (eCRF) will be used to ensure completeness and reliability of the data. The variables studied will include sociodemographic data, medical history, clinical and biological characteristics of the disease, diagnostic examinations performed, and the therapeutic strategies implemented. All information will be anonymized and used exclusively for research purposes.
Interventions
None listed
Sponsors
Société Algérienne de Formation et Recherche en Oncologie
ES Clinical Research
Ipsen
Astellas Pharma Inc
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
MALE
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged 19 years and older. * Diagnosis of prostate cancer confirmed histologically and/or biologically. * Patients followed in the participating oncology departments. * Written informed consent obtained. Non Inclusion Criteria: * Histological types other than carcinoma * Secondary tumors * Participation in an interventional study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Socio-demographic characteristics of patients with prostate cancer in Algeria | At Baseline ( Initial visit ) | Frequency (%) of sociodemographic characteristics of patients with prostate cancer in Algeria, including age at diagnosis, marital status, and socioeconomic level. |
| Personal and family history of cancer | At Baseline (Initial Visit) | Frequency (%) of patients with personal and family history of cancer. |
| Environmental and occupational exposures | At Baseline (Initial visit) | Frequency (%) of patients with environmental or occupational exposures. |
| Smoking history | At Baseline (Initial visit) | Frequency (%) of patients according to smoking status (current, former, never). |
| Alcohol consumption | At Baseline (Initial visit) | Frequency (%) of patients according to alcohol consumption (yes/no). |
| Initial symptoms and circumstances of diagnosis | At Baseline (Initial visit) | Frequency (%) of patients according to type of initial symptoms and circumstances of diagnosis. |
| International Prostate Symptom Score (IPSS) | At Baseline (Initial visit) | Distribution of patients according to the International Prostate Symptom Score (IPSS) at baseline. The IPSS is a validated questionnaire assessing the severity of lower urinary tract symptoms, with a total score ranging from 0 to 35, where higher scores indicate more severe (worse) symptoms. |
| Evolutionary status of patients | At Baseline (Initial visit) | Frequency (%) of patients according to disease status (in remission or with disease progression). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnosis by PSA testing | At Baseline (Initial visit) | % of patients diagnosed by PSA testing. |
| Diagnosis by imaging | At Baseline (Initial visit) | % of patients diagnosed by imaging. |
| Diagnosis by biopsy | At Baseline (Initial visit) | % of patients diagnosed by biopsy. |
| Time from symptom onset to first medical consultation | At Baseline (Initial visit) | Median time (in days) between onset of first symptoms and first medical consultation. |
| Time from first consultation to confirmed diagnosis | At Baseline (Initial visit) | Median time (in days) between first medical consultation and confirmed diagnosis. |
| Patients discussed in multidisciplinary team meetings | At Baseline (Initial visit) | % of patients discussed in tumor boards / multidisciplinary team meetings. |
| Initial treatment: Surgery | At Baseline (Initial visit) | % of patients receiving surgery as initial treatment. |
| Initial treatment: Radiotherapy | At Baseline (Initial visit) | % of patients receiving radiotherapy as initial treatment. |
| Initial treatment: Hormone therapy | At Baseline (Initial visit) | % of patients receiving hormone therapy as initial treatment. |
| Initial treatment: Active surveillance | At Baseline (Initial visit) | % of patients under active surveillance as initial management. |
| Time from diagnosis to treatment initiation | At Baseline (Initial visit) | Median time (in days) between diagnosis and treatment initiation. |
| Specialty of physician initiating treatment | At Baseline (Initial visit) | Medical specialty of the physician initiating treatment (urologist, oncologist, etc.). |
| Adverse events | At Baseline (Initial visit) | Frequency of adverse events by system/organ class and distribution according to severity grades (CTCAE grades 1 to 5). |
Countries
Algeria
Contacts
CONTACTBOUNEDJAR ADDA, Professor
Outcome results
None listed