Clinical trial · Interventional
VMAT for Dominant Intraprostatic Lesion
Dose Intensification With a Focal Boost to Dominant Intraprostatic Lesion Using Volumetric Modulated Arc Therapy /Image Guided Radiotherapy in Patients With Localized Prostate Cancer
NCT03030625CI-TRIAL-00078459CaP-VMAT-DILcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- 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 this study was to determine the efficacy and safety of the implementation of a program of " image-guided focal Intensification dose to intraprostatic dominant lesion " in men with localized prostate cancer (PCa) of intermediate and high risk (criteria NCCN) eligible to receive radiotherapy in the Department of Radiation Oncology of HUP (Hospital Universitario de La Princesa), within the established dose escalation protocol with intensity modulated image-guided radiotherapy (IMRT / IGRT).
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 |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IGRT/VMAT focal therapy boost to DIL | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- IGRT/VMAT focal therapy boost to DIL
- description
- Localized prostate cancer (PCa) of intermediate and high risk according to NCCN criteria
- interventionNames
- Radiation: IGRT/VMAT focal therapy boost to DIL
Primary outcomes (3)
- measure
- Number of Participants With Biochemical Failure at 5 Years
- timeFrame
- 5 years
- description
- Biochemical failure determined according to the Phoenix definition (nadir PSA + 2 ng/ml)
- measure
- Local Control
- timeFrame
- 6 and 9 months following radiotherapy
- description
- An image complete response was defined as disappearance of all morphological and functional lesions in mpMRI 6 to 9 months after radiotherapy.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male \> 18 years old with histologic diagnostic of prostate adenocarcinoma * Clinical stage cT2a-T3b N0-1 M0 (AJCC 7 th edition) * PSA (prostate-specific antigen) \< 100 ng/ml * Gleason score 6-10 * Life expectancy \> 5 years * Patients who accept the radiotherapy treatment * Patients provided written informed consent before participating in the trial Exclusion Criteria: * Transurethral resection of the prostate or prior prostate surgery * Previous pelvic radiotherapy * Urethral stenosis with or without prior dilations * IPSS\>15 * Rectal diverticuli or rectal vascular malformations * Metastatic disease * Severe psychiatric or medical conditions that could hamper both treatment and follow-up
References
Publications (25)
- BACKGROUNDArrayeh E, Westphalen AC, Kurhanewicz J, Roach M 3rd, Jung AJ, Carroll PR, Coakley FV. Does local recurrence of prostate cancer after radiation therapy occur at the site of primary tumor? Results of a longitudinal MRI and MRSI study. Int J Radiat Oncol Biol Phys. 2012 Apr 1;82(5):e787-93. doi: 10.1016/j.ijrobp.2011.11.030. Epub 2012 Feb 11. PMID 22331003
- BACKGROUNDCellini N, Morganti AG, Mattiucci GC, Valentini V, Leone M, Luzi S, Manfredi R, Dinapoli N, Digesu' C, Smaniotto D. Analysis of intraprostatic failures in patients treated with hormonal therapy and radiotherapy: implications for conformal therapy planning. Int J Radiat Oncol Biol Phys. 2002 Jul 1;53(3):595-9. doi: 10.1016/s0360-3016(02)02795-5. PMID 12062602
- BACKGROUNDPucar D, Hricak H, Shukla-Dave A, Kuroiwa K, Drobnjak M, Eastham J, Scardino PT, Zelefsky MJ. Clinically significant prostate cancer local recurrence after radiation therapy occurs at the site of primary tumor: magnetic resonance imaging and step-section pathology evidence. Int J Radiat Oncol Biol Phys. 2007 Sep 1;69(1):62-9. doi: 10.1016/j.ijrobp.2007.03.065. PMID 17707266
- BACKGROUNDMouraviev V, Villers A, Bostwick DG, Wheeler TM, Montironi R, Polascik TJ. Understanding the pathological features of focality, grade and tumour volume of early-stage prostate cancer as a foundation for parenchyma-sparing prostate cancer therapies: active surveillance and focal targeted therapy. BJU Int. 2011 Oct;108(7):1074-85. doi: 10.1111/j.1464-410X.2010.10039.x. Epub 2011 Apr 13. PMID 21489116
- BACKGROUNDPeeters ST, Heemsbergen WD, Koper PC, van Putten WL, Slot A, Dielwart MF, Bonfrer JM, Incrocci L, Lebesque JV. Dose-response in radiotherapy for localized prostate cancer: results of the Dutch multicenter randomized phase III trial comparing 68 Gy of radiotherapy with 78 Gy. J Clin Oncol. 2006 May 1;24(13):1990-6. doi: 10.1200/JCO.2005.05.2530. PMID 16648499
- BACKGROUNDKuban DA, Tucker SL, Dong L, Starkschall G, Huang EH, Cheung MR, Lee AK, Pollack A. Long-term results of the M. D. Anderson randomized dose-escalation trial for prostate cancer. Int J Radiat Oncol Biol Phys. 2008 Jan 1;70(1):67-74. doi: 10.1016/j.ijrobp.2007.06.054. Epub 2007 Aug 31.