NCT05382182

Brief 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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 19, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 19, 2022

Status Verified

May 1, 2022

Enrollment Period

7 months

First QC Date

May 15, 2022

Last Update Submit

May 15, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • overall survival

    Overall survival defined as the time from the date of diagnosis to the last date seen .

    6 months

  • 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

  • disease free survival

    Disease free survival defined as the time from the end of treatment to the date of first relapse .

    6 months

Interventions

outcome of hormonal treatment as androgen deprivation therapy on prostate cancer patient on survival and relapse

outcome of radiotherapy as external beam radiotherapy on prostate cancer patient on survival and relapse

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

prostate cancer patients

You may qualify if:

  • Patients at age of 18 years old and above.
  • All stages and grades of prostate cancer.
  • Epithelial types of prostate cancer.

You may not qualify if:

  • Age below 18 years old.
  • Presence of other malignancies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

Related 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.

    PMID: 27132038BACKGROUND
  • 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. doi: 10.1007/s00120-016-0264-5. German.

    PMID: 27830286BACKGROUND
  • 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, Rouviere 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.

    PMID: 32146018BACKGROUND
  • 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.

    PMID: 29045233BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Androgen Antagonists

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hormone AntagonistsHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Central Study Contacts

Aya A Sayed, resident

CONTACT

Ali M Ali, assisstant professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor at oncology department at faculty of medicine sohag university hospital

Study Record Dates

First Submitted

May 15, 2022

First Posted

May 19, 2022

Study Start

June 1, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

May 19, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

Locations