NCT05428319

Brief Summary

Prostatic carcinoma is the second most common cancer in men with high incidence of morbidity and mortality. It is a common health problem. Most cases occur at the age of 50 years, reaching its peak at 60-70 years of age. Diagnosis of prostatic carcinoma is still a problematic issue as accurate diagnosis can be very challenging due to the presence of either a small focus of cancer or the presence of many benign mimickers of malignancy. Six transmembrane epithelial antigen of the prostate 1 (STEAP-1) is primarily localized at the cell membrane, mostly at cell-cell junctions, but it may also be found dispersed in the cytoplasm. In prostate, the expression of STEAP-1 is higher in neoplastic tissues compared to its restricted expression in normal prostatic samples. The antibody designated as p40 recognizes exclusively ΔNp63 and not TAp63. In prostate tissues, it has been shown that p40, the ΔNp63 isoform of p63, stains prostatic basal cells as reliable as p63 in most cases. Furthermore, aberrant staining of tumor cells was seen more rarely with p40 than with p63. In this study, the investigators hope to solve some problematic issues in diagnosis of prostatic carcinoma and reach the better way to distinguish prostatic carcinoma from mimicking lesions by using both STEAP-1 and p 40. Also, the way to detect cancer at early stage of development and its progression which is extremely important as it allows establishing the most effective treatment and predicting patient's outcome.

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
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2022

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

June 16, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 23, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

September 8, 2022

Status Verified

September 1, 2022

Enrollment Period

1.7 years

First QC Date

June 16, 2022

Last Update Submit

September 3, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Diagnosis of Prostatic Carcinoma

    Immunohistochemical Expression of STEAP-1 and p40 in Prostatic carcinoma and mimickers

    One or two days after staining sections with the markers

Eligibility Criteria

Sexmale
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Formalin-fixed and paraffin embedded prostatic tissue blocks from 70 patients

You may qualify if:

  • Trans-rectal ultrasound guided biopsy (TRUS) procedure, transurethral resection prostatectomy (TURP) and radical prostatectomy.
  • Prostatic adenocarcinoma and prostatic lesions that mimic prostatic adenocarcinoma

You may not qualify if:

  • Patients with recurrence of the primary tumor.
  • Patients with a history of preoperative chemotherapy and/or radiotherapy.
  • Insufficient or tiny tissue biopsies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aliaa Bakr Ahmed

Sohag, 201, Egypt

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Aliaa Bakr

    Faculty of medicine, Sohag University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

June 16, 2022

First Posted

June 23, 2022

Study Start

December 1, 2022

Primary Completion

August 1, 2024

Study Completion

December 1, 2024

Last Updated

September 8, 2022

Record last verified: 2022-09

Locations