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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05382182
Other study ID # Soh-Med-22-05-03
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2022
Est. completion date December 31, 2022

Study information

Verified date May 2022
Source Sohag University
Contact Aya A Sayed, resident
Phone 01023423815
Email ayaahmed@med.sohag.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Worldwide, prostate cancer is the most commonly diagnosed male cancer and the fourth leading cause of cancer death in men. Risk stratification is according to cancer stage, Gleason score, and PSA level . Definitive treatment of localized disease ( low and favorable intermediate risk) includes watchful waiting , active surveillance , radiation therapy , radical prostatectomy and cryotherapy .Primary treatment of unfavorable intermediate risk , high risk localized disease and locally advanced prostate cancer , includes both radical prostatectomy (RP) and EBRT + long-term androgen deprivation therapy (ADT) .Treatment options of metastatic prostate cancer include pain medications, bisphosphonates, hormonal treatment, chemotherapy, radiotherapy, immunotherapy, focused radiation, and other targeted therapies .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients at age of 18 years old and above. - All stages and grades of prostate cancer. - Epithelial types of prostate cancer. Exclusion Criteria: - Age below 18 years old. - Presence of other malignancies.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
androgen deprivation therapy
outcome of hormonal treatment as androgen deprivation therapy on prostate cancer patient on survival and relapse
Radiation:
external beam radiotherapy
outcome of radiotherapy as external beam radiotherapy on prostate cancer patient on survival and relapse

Locations

Country Name City State
Egypt Sohag University Hospital Sohag

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Costello LC, Franklin RB. A comprehensive review of the role of zinc in normal prostate function and metabolism; and its implications in prostate cancer. Arch Biochem Biophys. 2016 Dec 1;611:100-112. doi: 10.1016/j.abb.2016.04.014. Epub 2016 Apr 27. Review. — View Citation

Herden J, Heidenreich A, Weißbach L. [TNM-Classification of localized prostate cancer : The clinical T-category does not correspond to the required demands]. Urologe A. 2016 Dec;55(12):1564-1572. German. — View Citation

Moris L, Cumberbatch MG, Van den Broeck T, Gandaglia G, Fossati N, Kelly B, Pal R, Briers E, Cornford P, De Santis M, Fanti S, Gillessen S, Grummet JP, Henry AM, Lam TBL, Lardas M, Liew M, Mason MD, Omar MI, Rouvière O, Schoots IG, Tilki D, van den Bergh RCN, van Der Kwast TH, van Der Poel HG, Willemse PM, Yuan CY, Konety B, Dorff T, Jain S, Mottet N, Wiegel T. Benefits and Risks of Primary Treatments for High-risk Localized and Locally Advanced Prostate Cancer: An International Multidisciplinary Systematic Review. Eur Urol. 2020 May;77(5):614-627. doi: 10.1016/j.eururo.2020.01.033. Epub 2020 Mar 4. — View Citation

Verma S, Choyke PL, Eberhardt SC, Oto A, Tempany CM, Turkbey B, Rosenkrantz AB. The Current State of MR Imaging-targeted Biopsy Techniques for Detection of Prostate Cancer. Radiology. 2017 Nov;285(2):343-356. doi: 10.1148/radiol.2017161684. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary overall survival Overall survival defined as the time from the date of diagnosis to the last date seen . 6 months
Primary progression free survival Progression-free survival defined as the length of time during and after the treatment of cancer that a patient lives with the disease but it does not get worse. 6 months
Primary disease free survival Disease free survival defined as the time from the end of treatment to the date of first relapse . 6 months
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