Prostate CancerPhase 2NCT05285319
Trial Comparing Radical Radiotherapy to Prostate Only VS Prostate And Pelvic Lymph Nodes in Intermediate And High Risk Prostate Cancer
A Phase 2 study testing Prostate Only Radiation and Prostate and Pelvic Lymph Node Radiation in people with Prostate Cancer, run by Cairo University at 1 site in Egypt.
Trial summary
This phase II randomized controlled study aims to compare the treatment results of intermediate and high risk prostate cancer patients treated with hormonal therapy and radical radiotherapy with or without pelvic lymph nodes in NCI- Cairo University. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Prostate Only Radiation and Prostate and Pelvic Lymph Node Radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Feb 2020to 1 Apr 2023
- Phase
- Phase 2
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically-proven prostatic adenocarcinoma.
- Risk stratification from intermediate to very high risk will be included according to NCCN guide lines September 5, 2019 version 4.2019:
- Intermediate risk: T2b or T2c and/or GS =7 and/or PSA >10-20. Both the favorable intermediate (1 intermediate risk factor (IRF) and Grade Group 1 or 2 and <50% biopsy core positive) and unfavorable intermediate risk (2 or 3 IRFs and/or Grade Group 3 and/or ≥50% biopsy cores positive) will be included.
- High risk: T3a or PSA >20 or Grade Group 4 or 5, not very high risk.
- Very high risk: T3b-4, primary gleason pattern 5 OR >4 cores with grade group 4 or 5
- N stage: N0
- M Stage: M0
- Performance Status: PS 0-2
Who cannot join
- Low risk prostate cancer
- Histologies other than adenocarcinoma
- Patients with significant comorbidities might affect treatment completion and follow up
- Previously received pelvic radiotherapy
- Patients with metastatic disease
- Poor performance status (PS ≥ 3)
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
National Cancer Institute - Cairo University
Cairo
Ahmed Abdelhamid, +201203262526, ahmed.abdelhamid@nci.cu.edu.eg
About this study
Official title: Phase II Randomized Control Trial Comparing Radical Hypofractionated Radiotherapy to Prostate Only VS Prostate And Pelvic Lymph Nodes in Intermediate And High Risk Prostate Cancer
This phase II randomized controlled study aims to compare the treatment results of intermediate and high risk prostate cancer patients treated with hormonal therapy and radical radiotherapy with or without pelvic lymph nodes in NCI- Cairo University.
Read the detailed description
Study Design :
Phase II prospective randomized trial with 2 arms • Prostate Only (Arm A)
Hypofractionated Intensity modulated radiotherapy (IMRT) to the prostate only to dose of 60Gy/20fractions (3 Gy per fraction)
- Prostate \& Pelvic Lymph Nodes (Arm B)
Hypofractionated Intensity modulated radiotherapy (IMRT) with elective pelvic nodes irradiation up to 44Gy/20 fractions (2.2 Gy per fraction) with a Simultaneous Integrated Boost (SIB) to the prostate to dose of 60Gy/20fractions (3 Gy per fraction)
- Conditions
- Prostate Cancer
- Being tested
- Prostate Only Radiation, Prostate and Pelvic Lymph Node Radiation
- Keywords
- Prostate Cancer, Intermediate Risk Prostate Cancer, High Risk Prostate Cancer, Hypofractionated Radiotherapy, Pelvic Lymph Node Irradiation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate Only RadiationRadiation
Prostate Only Radiation for Intermediate and High Risk Prostate cancer
Prostate and Pelvic Lymph Node RadiationRadiation
Prostate and Pelvic Lymph Node Radiation for Intermediate and High Risk Prostate cancer
| Study group | Role | What they receive |
|---|---|---|
| Prostate Only (Arm A) | Experimental | Hypofractionated Intensity modulated radiotherapy (IMRT) to the prostate only to a dose of 60Gy/20fractions (3 Gy per fraction) Receives: Radiation: Prostate Only Radiation |
| Prostate and Pelvic Lymph Nodes (Arm B) | Experimental | Hypofractionated Intensity modulated radiotherapy (IMRT) with elective pelvic nodes irradiation up to 44Gy/20 fractions (2.2 Gy per fraction) with a Simultaneous Integrated Boost (SIB) to the prostate to a dose of 60Gy/20fractions (3 Gy per fraction) Receives: Radiation: Prostate and Pelvic Lymph Node Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute toxicity
Compare Acute toxicity between the 2 arms using Radiation Therapy Oncology Group (RTOG) acute morbidity scoring criteria.
Measured: 90 days post the end of radiation therapy
Local Control
Compare Local control (LC) with minimum follow up of 1 year in both groups
Measured: 1 year
Secondary outcomes (3)
Biochemical free survivals (BFS)
Biochemical free survivals (BFS) with minimum follow up of 1 year in both groups.
Measured: 1 year
Late toxicity
Compare Late toxicity (using RTOG/EORTC Late Radiation Toxicity Scale)
Measured: 1 year
Overall survival (OS)
Compare overall survival in the study population
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start9 Feb 2020
- Primary completion1 Apr 2022
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase II prospective randomized trial with 2 arms: * Prostate Only (Arm A) o Hypofractionated Intensity modulated radiotherapy (IMRT) to the prostate only to dose of 60Gy/20fractions (3 Gy per fraction) * Prostate \& Pelvic Lymph Nodes (Arm B) * Hypofractionated Intensity modulated radiotherapy (IMRT) with elective pelvic nodes irradiation up to 44Gy/20 fractions (2.2 Gy per fraction) with a Simultaneous Integrated Boost (SIB) to the prostate to dose of 60Gy/20fractions (3 Gy per fraction)
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelhamid, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05285319
- Sponsor's protocol ID
- RO2002-30906
- Status last verified
- Aug 2022
- First submitted
- 9 Mar 2022
- Last updated
- 10 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Control Trial Comparing Radical Hypofractionated Radiotherapy to Prostate Only VS Prostate And Pelvic Lymph Nodes in Intermediate And High Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT05285319
- Acronym / sponsor ID
- RO2002-30906
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Intermediate Risk Prostate Cancer, High Risk Prostate Cancer, Hypofractionated Radiotherapy, Pelvic Lymph Node Irradiation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 9 Feb 2020 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 17 Mar 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.
This phase II randomized controlled study aims to compare the treatment results of intermediate and high risk prostate cancer patients treated with hormonal therapy and radical radiotherapy with or without pelvic lymph nodes in NCI- Cairo University.
Detailed description
Study Design :
Phase II prospective randomized trial with 2 arms • Prostate Only (Arm A)
Hypofractionated Intensity modulated radiotherapy (IMRT) to the prostate only to dose of 60Gy/20fractions (3 Gy per fraction)
- Prostate \& Pelvic Lymph Nodes (Arm B)
Hypofractionated Intensity modulated radiotherapy (IMRT) with elective pelvic nodes irradiation up to 44Gy/20 fractions (2.2 Gy per fraction) with a Simultaneous Integrated Boost (SIB) to the prostate to dose of 60Gy/20fractions (3 Gy per fraction)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase II prospective randomized trial with 2 arms: * Prostate Only (Arm A) o Hypofractionated Intensity modulated radiotherapy (IMRT) to the prostate only to dose of 60Gy/20fractions (3 Gy per fraction) * Prostate \& Pelvic Lymph Nodes (Arm B) * Hypofractionated Intensity modulated radiotherapy (IMRT) with elective pelvic nodes irradiation up to 44Gy/20 fractions (2.2 Gy per fraction) with a Simultaneous Integrated Boost (SIB) to the prostate to dose of 60Gy/20fractions (3 Gy per fraction)
| Arm | Type | Receives |
|---|---|---|
| Prostate Only (Arm A) | Experimental | Radiation: Prostate Only RadiationHypofractionated Intensity modulated radiotherapy (IMRT) to the prostate only to a dose of 60Gy/20fractions (3 Gy per fraction) |
| Prostate and Pelvic Lymph Nodes (Arm B) | Experimental | Radiation: Prostate and Pelvic Lymph Node RadiationHypofractionated Intensity modulated radiotherapy (IMRT) with elective pelvic nodes irradiation up to 44Gy/20 fractions (2.2 Gy per fraction) with a Simultaneous Integrated Boost (SIB) to the prostate to a dose of 60Gy/20fractions (3 Gy per fraction) |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically-proven prostatic adenocarcinoma.
- Risk stratification from intermediate to very high risk will be included according to NCCN guide lines September 5, 2019 version 4.2019:
- N stage: N0
- M Stage: M0
- Performance Status: PS 0-2
Key exclusion criteria (6 listed)
- Low risk prostate cancer
- Histologies other than adenocarcinoma
- Patients with significant comorbidities might affect treatment completion and follow up
- Previously received pelvic radiotherapy
- Patients with metastatic disease
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 |
|---|---|---|
| Prostate Only RadiationProstate Only Radiation for Intermediate and High Risk Prostate cancer | Radiation | Prostate Only (Arm A) |
| Prostate and Pelvic Lymph Node RadiationProstate and Pelvic Lymph Node Radiation for Intermediate and High Risk Prostate cancer | Radiation | Prostate and Pelvic Lymph Nodes (Arm B) |
Primary outcome
Acute toxicity
Time frame: 90 days post the end of radiation therapy
Compare Acute toxicity between the 2 arms using Radiation Therapy Oncology Group (RTOG) acute morbidity scoring criteria.
Local Control
Time frame: 1 year
Compare Local control (LC) with minimum follow up of 1 year in both groups
3 secondary outcomes
Biochemical free survivals (BFS)
Time frame: 1 year
Late toxicity
Time frame: 1 year
Overall survival (OS)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prostate Only Radiation and Prostate and Pelvic Lymph Node Radiation in people with Prostate Cancer, run by Cairo 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 8 inclusion and 6 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 10 Aug 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ahmed Abdelhamid, Msc (+201203262526, ahmed.abdelhamid@nci.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute toxicity (time frame: 90 days post the end of radiation therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2022.