FK-PC101 as Adjuvant Therapy for Men With High-Risk Prostate Cancer
NCT06636682
Adenocarcinoma, Carcinoma
Chicago, Illinois, United States
View Trial DetailsNCT Number: NCT07484971
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.
Interested in participating?
Request Info19 year and older
Male
Observational
CAC Adrar - Oncology Department, Adrar, Algeria
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Non Inclusion Criteria:
Time frame: At Baseline ( Initial visit )
Frequency (%) of sociodemographic characteristics of patients with prostate cancer in Algeria, including age at diagnosis, marital status, and socioeconomic level.
Time frame: At Baseline (Initial Visit)
Frequency (%) of patients with personal and family history of cancer.
Time frame: At Baseline (Initial visit)
Frequency (%) of patients with environmental or occupational exposures.
Time frame: At Baseline (Initial visit)
Frequency (%) of patients according to smoking status (current, former, never).
Time frame: At Baseline (Initial visit)
Frequency (%) of patients according to alcohol consumption (yes/no).
Time frame: At Baseline (Initial visit)
Frequency (%) of patients according to type of initial symptoms and circumstances of diagnosis.
Time frame: 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.
Time frame: At Baseline (Initial visit)
Frequency (%) of patients according to disease status (in remission or with disease progression).
Time frame: At Baseline (Initial visit)
% of patients diagnosed by PSA testing.
Time frame: At Baseline (Initial visit)
% of patients diagnosed by imaging.
Time frame: At Baseline (Initial visit)
% of patients diagnosed by biopsy.
Time frame: At Baseline (Initial visit)
Median time (in days) between onset of first symptoms and first medical consultation.
Time frame: At Baseline (Initial visit)
Median time (in days) between first medical consultation and confirmed diagnosis.
Time frame: At Baseline (Initial visit)
% of patients discussed in tumor boards / multidisciplinary team meetings.
Time frame: At Baseline (Initial visit)
% of patients receiving surgery as initial treatment.
Time frame: At Baseline (Initial visit)
% of patients receiving radiotherapy as initial treatment.
Time frame: At Baseline (Initial visit)
% of patients receiving hormone therapy as initial treatment.
Time frame: At Baseline (Initial visit)
% of patients under active surveillance as initial management.
Time frame: At Baseline (Initial visit)
Median time (in days) between diagnosis and treatment initiation.
Time frame: At Baseline (Initial visit)
Medical specialty of the physician initiating treatment (urologist, oncologist, etc.).
Time frame: At Baseline (Initial visit)
Frequency of adverse events by system/organ class and distribution according to severity grades (CTCAE grades 1 to 5).
Contact information is provided by the study sponsor or research team.
Société Algérienne de Formation et Recherche en Oncologie
Other
Acronym: CLIQQC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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