Outcome Of Treatment Of Prostate Cancer at Sohag University Hospital Between 2017 to 2021

Prostate Cancer Clinical Trial

Official title:

Outcome Of Treatment Of Prostate Cancer at Sohag University Hospital Between 2017 to 2021

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05382182
• Other study ID #: Soh-Med-22-05-03
• Status: Not yet recruiting
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

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