NCT07489729Completed
Hypo Fractionated Versus Conventional IMRT in Unfavorable Intermediate- and High-Risk Prostate Cancer
Hypo Fractionated Versus Conventional IMRT in Unfavorable Intermediate- and High-Risk Prostate Cancer: A Phase II Comparative Study of PSA Kinetics and Dosimetric Outcomes
Source: ClinicalTrials.gov · Last updated 24 Mar 2026
Brief summary (registry, in English)
The aim of the study is 1. Statistical evaluation of patients' characteristics who have intermediate \& high risk localized prostate cancer. 2. Statistical analysis of treatment efficacy of combined hormonal therapy \& hypo fractionated intensity modulated radiotherapy compared with conventionally fractionated radiotherapy plus hormonal treatment as regard biochemical failure, disease free survival \& overall survival. 3. Evaluation of acute as well as late toxic side effects after radiotherapy.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 18 Mar 2026
- Start date
- 30 Jun 2022
- Primary completion date
- 30 Jun 2024
- Lead sponsor
- Tanta University
- Diseases
- Prostate cancer
- NCT number
- NCT07489729
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 30 Jun 2022 to the primary completion date, 30 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with any contraindication to pelvic radiotherapy: including, previous pelvic radiotherapy, inflammatory bowel disease or severe bladder irritability.
- Patients who had prior surgical treatment for carcinoma of the prostate apart from trans-urethral resection,
Other illness
- Patients with a history of other malignancies, except: non-melanoma skin cancer.
- Co-morbidities as Congestive heart failure, recent myocardial infarction.
Other
- Nodal or distant metastasis proven by a computed tomography pelvis or bone scan,
Who the study is looking for
- Biopsy proven prostate adenocarcinoma
- Patient has been classified as intermediate or high risk according to the National Comprehensive Cancer Network v2018 .
- Clinically localized stage (cT2-T3b N0M0, using the AJCC 8th TNM classification) .
- Eastern Cooperative Oncology Group performance status ranged from 0-1 . - Mean age was 65 years (range: 50-80 years).
- a prostate-specific antigen test at the time of diagnosis ≥10 ng/ml.
- Gleason scores range from 7 to 10.
- The patient must not receive any cytotoxic anticancer therapy for prostate cancer prior to randomization.
- Adequate hematological, hepatic, renal function tests
Age in the registry: 50 years to 80 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tanta university Coordinator of this site? Confirm its status | Tanta | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.