Prostate CancerNCT05382182
Outcome Of Treatment Of Prostate Cancer at Sohag University Hospital Between 2017 to 2021
An observational study of Prostate Cancer, run by Sohag University at 1 site in Egypt.
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 . Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- androgen deprivation therapy and external beam radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Adult, Older adult
Study population: prostate cancer patients
Who may be able to join
- Patients at age of 18 years old and above.
- All stages and grades of prostate cancer.
- Epithelial types of prostate cancer.
Who cannot join
- Age below 18 years old.
- Presence of other malignancies.
Trial locations and contacts
1 site in 1 country.
Ali M Ali, assisstant professor contact
About this study
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 .
- Conditions
- Prostate Cancer
- Being tested
- androgen deprivation therapy, external beam radiotherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
androgen deprivation therapyDrug
outcome of hormonal treatment as androgen deprivation therapy on prostate cancer patient on survival and relapse
external beam radiotherapyRadiation
outcome of radiotherapy as external beam radiotherapy on prostate cancer patient on survival and relapse
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Overall survival defined as the time from the date of diagnosis to the last date seen .
Measured: 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.
Measured: 6 months
disease free survival
Disease free survival defined as the time from the end of treatment to the date of first relapse .
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start1 Jun 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Ahmed Sayed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382182
- Sponsor's protocol ID
- Soh-Med-22-05-03
- Status last verified
- May 2022
- First submitted
- 15 May 2022
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 27132038Herden 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.
PubMed 27830286Moris 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.
PubMed 32146018Verma 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.
PubMed 29045233
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Of Treatment Of Prostate Cancer at Sohag University Hospital Between 2017 to 2021
- ClinicalTrials.gov ID
- NCT05382182
- Acronym / sponsor ID
- Soh-Med-22-05-03
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- prostate cancer patients
Key inclusion criteria (3 listed)
- Patients at age of 18 years old and above.
- All stages and grades of prostate cancer.
- Epithelial types of prostate cancer.
Key exclusion criteria (2 listed)
- Age below 18 years old.
- Presence of other malignancies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| androgen deprivation therapyoutcome of hormonal treatment as androgen deprivation therapy on prostate cancer patient on survival and relapse | Drug | – |
| external beam radiotherapyoutcome of radiotherapy as external beam radiotherapy on prostate cancer patient on survival and relapse | Radiation | – |
Primary outcome
overall survival
Time frame: 6 months
Overall survival defined as the time from the date of diagnosis to the last date seen .
progression free survival
Time frame: 6 months
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.
disease free survival
Time frame: 6 months
Disease free survival defined as the time from the end of treatment to the date of first relapse .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Background: PubMed 27132038Costello 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.
- Background: PubMed 27830286Herden 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.
- Background: PubMed 32146018Moris 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.
- Background: PubMed 29045233Verma 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali M Ali, assisstant professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aya A Sayed, resident (01023423815, ayaahmed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05382182, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.