Clinical trial · Observational
Hypofractionated Intensity Modulated and Image Guided Radiotherapy for Localized Prostate Cancer
Hypofractionated Intensity Modulated and Image Guided Radiotherapy for Localized Prostate Cancer: a Prospective Cohort.
- 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)
Hypofractionated intensity modulated and image guided radiotherapy (HypoIGRT) with fewer high-fraction-size treatments would be beneficial for prostate cancer because it would deliver a larger biological-equivalent dose to the tumor than would conventional treatment in 1.8-2.0 Gy fractions, while maintaining a similar or lower incidence of late normal tissue reactions. Thus, the investigators aim to assess the hypothesis that HypoIGRT treatment for localized prostate cancer will improve the therapeutic ratio by either: 1. Reducing normal tissue, mainly genitourinary and gastrointestinal, toxicity and / or 2. Improving tumour control, mainly freedom from biochemical failure survival.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HypoIGRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- HypoIGRT
- description
- 1. Low Risk (T1-T2a, Gleason score 6, and PSA \< 10 ng/mL) 2. Intermediate Risk (T1-T2c, Gleason 7, and PSA 10-20 ng/mL) 3. High Risk (T3 - 4 , Gleason 8-10, and/or PSA \> 20 ng/mL) Neoadjuvant hormone therapy is allowed on groups 2 and 3
- interventionNames
- Radiation: HypoIGRT
Primary outcomes (4)
- measure
- Overall Acute Gastrointestinal Toxicity - According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0.
- timeFrame
- During and up to 90 days after treatment ends (acute event)
- description
- According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 - toxicity will be graduated in a scale from 0 - 5
- measure
- Overall Acute Genitourinary Toxicity - According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed, previously untreated locally confined adenocarcinoma of the prostate 2. Patients older than 18 years old 3. Patients who accept to perform follow up in the radiation oncology department 4. Performance Status ≥ 70 5. Written informed consent Exclusion Criteria: 1. Prior pelvic radiotherapy, radical prostatectomy, brachytherapy, cryotherapy or other local treatment 2. Presenting with positive pelvic lymph nodes or metastatic at the diagnosis (M1)
References
Publications (4)
- BACKGROUNDChang P, Szymanski KM, Dunn RL, Chipman JJ, Litwin MS, Nguyen PL, Sweeney CJ, Cook R, Wagner AA, DeWolf WC, Bubley GJ, Funches R, Aronovitz JA, Wei JT, Sanda MG. Expanded prostate cancer index composite for clinical practice: development and validation of a practical health related quality of life instrument for use in the routine clinical care of patients with prostate cancer. J Urol. 2011 Sep;186(3):865-72. doi: 10.1016/j.juro.2011.04.085. Epub 2011 Jul 23. PMID 21788038
- BACKGROUNDLeborgne F, Fowler J. Late outcomes following hypofractionated conformal radiotherapy vs. standard fractionation for localized prostate cancer: a nonrandomized contemporary comparison. Int J Radiat Oncol Biol Phys. 2009 Aug 1;74(5):1441-6. doi: 10.1016/j.ijrobp.2008.10.087. Epub 2009 Apr 22. PMID 19395194
- BACKGROUNDMoraes FY, Siqueira GM, Abreu CE, da Silva JL, Gadia R. Hypofractioned radiotherapy in prostate cancer: is it the next step? Expert Rev Anticancer Ther. 2014 Nov;14(11):1271-6. doi: 10.1586/14737140.2014.972380. PMID 25367322
- BACKGROUNDDearnaley D, Syndikus I, Sumo G, Bidmead M, Bloomfield D, Clark C, Gao A, Hassan S, Horwich A, Huddart R, Khoo V, Kirkbride P, Mayles H, Mayles P, Naismith O, Parker C, Patterson H, Russell M, Scrase C, South C, Staffurth J, Hall E. Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: preliminary safety results from the CHHiP randomised controlled trial. Lancet Oncol. 2012 Jan;13(1):43-54. doi: 10.1016/S1470-2045(11)70293-5. Epub 2011 Dec 12. PMID 22169269