Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hypofractionated Dose | — | UNRESOLVED | — |
| Prostate Cancer Patients | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional Intensity-Modulated Radiation Therapy | Radiation | — | UNRESOLVED |
| Hypofractionated Intensity-Modulated Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group A
- description
- hypofractionated Intensity-Modulated Radiation Therapy
- interventionNames
- Radiation: Hypofractionated Intensity-Modulated Radiation Therapy
- type
- ACTIVE_COMPARATOR
- label
- Group B
- description
- conventional fractionated Intensity-Modulated Radiation Therapy
- interventionNames
- Radiation: Conventional Intensity-Modulated Radiation Therapy
Primary outcomes (1)
- measure
- Tumor response
- timeFrame
- Three monthly the first year after radiation, 4 months the second and third year.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Patients with a history of other malignancies, except: non-melanoma skin cancer. * 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, * Nodal or distant metastasis proven by a computed tomography pelvis or bone scan, * Co-morbidities as Congestive heart failure, recent myocardial infarction.
References
Publications (0)
Data not yet available