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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IGRT/VMAT focal therapy boost to DIL | Other | Localized prostate cancer (PCa) of intermediate and high risk according to NCCN criteria |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IGRT/VMAT focal therapy boost to DIL | Radiation | Image-guided/VMAT 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Biochemical Failure at 5 Years | Biochemical failure determined according to the Phoenix definition (nadir PSA + 2 ng/ml) | 5 years |
| Local Control | An image complete response was defined as disappearance of all morphological and functional lesions in mpMRI 6 to 9 months after radiotherapy. | 6 and 9 months following radiotherapy |
| Acute and Late Rectal and Urinary Complications | Acute and late rectal and urinary complications defined as the number of participants with treatment-related adverse events assessed by Common Terminology Criteria for Adverse Events CTCAE v4.0 and Radiation- Therapy Oncology Group/ European Organization for Research and Treatment of Cancer RTOG/EORTC scales (been 0: no toxicity and 4: most severe toxicity). | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Free of Biochemical Progression | Biochemical disease-free survival according to the Phoenix definition (PSA >2 ng/mL above the currently observed PSA nadir. Defined as the time from enrollment to progression of biochemical disease, or death from any cause, or censoring at the date of the last contact. | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de la Princesa | Madrid | 28006 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22331003 | Background | Arrayeh 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. | |
| 12062602 |
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| ID | Title | Description |
|---|---|---|
| FG000 | IGRT/VMAT Focal Therapy Boost to DIL | Localized prostate cancer (PCa) of intermediate and high risk according to NCCN criteria IGRT/VMAT focal therapy boost to DIL: Image-guided/VMAT 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IGRT/VMAT Focal Therapy Boost to DIL | Localized prostate cancer (PCa) of intermediate and high risk according to NCCN criteria IGRT/VMAT focal therapy boost to DIL: Image-guided/VMAT 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Biochemical Failure at 5 Years | Biochemical failure determined according to the Phoenix definition (nadir PSA + 2 ng/ml) | Posted | Count of Participants | Participants | 5 years |
|
|
5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IGRT/VMAT Focal Therapy Boost to DIL | Localized prostate cancer (PCa) of intermediate and high risk according to NCCN criteria IGRT/VMAT focal therapy boost to DIL: Image-guided/VMAT 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute rectal toxicity | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Almudena Zapatero Laborda | Hospital Universitario de La Princesa | +34 915 20 22 00 | almudena.zapatero@salud.madrid.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 18, 2020 | Aug 4, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Quality of Life (QoL) Assessed by the Expanded Prostate Cancer Index Composite EPIC16 Scale 0-60 (Best to Worst). The Total Score of the Scale is the Summatory of the Domain's Score |
Assessment of the QoL perceived by the patient in the urinary incontinence, urinary abstraction irritation, bowel function, sexual function and vitality/hormone functions domains |
| 5 years |
| Disease-free Survival (DFS) | Survival free of any event including biochemical failure, local failure, distant metastasis or death | 5 years |
| Verification of Safety Margins | Quantification of the systematic and random errors during the preparation and administration of the radiotherapy treatment in 15 patients. Security margins estimation according to Van Herk formula | 5 years |
| Cellini 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. |
| 17707266 | Background | Pucar 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. |
| 21489116 | Background | Mouraviev 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. |
| 16648499 | Background | Peeters 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. |
| 17765406 | Background | Kuban 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. |
| 21147514 | Background | Beckendorf V, Guerif S, Le Prise E, Cosset JM, Bougnoux A, Chauvet B, Salem N, Chapet O, Bourdain S, Bachaud JM, Maingon P, Hannoun-Levi JM, Malissard L, Simon JM, Pommier P, Hay M, Dubray B, Lagrange JL, Luporsi E, Bey P. 70 Gy versus 80 Gy in localized prostate cancer: 5-year results of GETUG 06 randomized trial. Int J Radiat Oncol Biol Phys. 2011 Jul 15;80(4):1056-63. doi: 10.1016/j.ijrobp.2010.03.049. Epub 2010 Dec 14. |
| 24581940 | Background | Dearnaley DP, Jovic G, Syndikus I, Khoo V, Cowan RA, Graham JD, Aird EG, Bottomley D, Huddart RA, Jose CC, Matthews JH, Millar JL, Murphy C, Russell JM, Scrase CD, Parmar MK, Sydes MR. Escalated-dose versus control-dose conformal radiotherapy for prostate cancer: long-term results from the MRC RT01 randomised controlled trial. Lancet Oncol. 2014 Apr;15(4):464-73. doi: 10.1016/S1470-2045(14)70040-3. Epub 2014 Feb 26. |
| 20124169 | Background | Zietman AL, Bae K, Slater JD, Shipley WU, Efstathiou JA, Coen JJ, Bush DA, Lunt M, Spiegel DY, Skowronski R, Jabola BR, Rossi CJ. Randomized trial comparing conventional-dose with high-dose conformal radiation therapy in early-stage adenocarcinoma of the prostate: long-term results from proton radiation oncology group/american college of radiology 95-09. J Clin Oncol. 2010 Mar 1;28(7):1106-11. doi: 10.1200/JCO.2009.25.8475. Epub 2010 Feb 1. |
| 20932659 | Background | Zapatero A, Garcia-Vicente F, Martin de Vidales C, Cruz Conde A, Ibanez Y, Fernandez I, Rabadan M. Long-term results after high-dose radiotherapy and adjuvant hormones in prostate cancer: how curable is high-risk disease? Int J Radiat Oncol Biol Phys. 2011 Dec 1;81(5):1279-85. doi: 10.1016/j.ijrobp.2010.07.1975. Epub 2010 Oct 6. |
| 11516871 | Background | King CR, Fowler JF. A simple analytic derivation suggests that prostate cancer alpha/beta ratio is low. Int J Radiat Oncol Biol Phys. 2001 Sep 1;51(1):213-4. doi: 10.1016/s0360-3016(01)01651-0. No abstract available. |
| 19457807 | Background | Turkbey B, Albert PS, Kurdziel K, Choyke PL. Imaging localized prostate cancer: current approaches and new developments. AJR Am J Roentgenol. 2009 Jun;192(6):1471-80. doi: 10.2214/AJR.09.2527. |
| 22322308 | Background | Barentsz JO, Richenberg J, Clements R, Choyke P, Verma S, Villeirs G, Rouviere O, Logager V, Futterer JJ; European Society of Urogenital Radiology. ESUR prostate MR guidelines 2012. Eur Radiol. 2012 Apr;22(4):746-57. doi: 10.1007/s00330-011-2377-y. Epub 2012 Feb 10. |
| 21336090 | Background | Ippolito E, Mantini G, Morganti AG, Mazzeo E, Padula GD, Digesu C, Cilla S, Frascino V, Luzi S, Massaccesi M, Macchia G, Deodato F, Mattiucci GC, Piermattei A, Cellini N. Intensity-modulated radiotherapy with simultaneous integrated boost to dominant intraprostatic lesion: preliminary report on toxicity. Am J Clin Oncol. 2012 Apr;35(2):158-62. doi: 10.1097/COC.0b013e318209cd8f. |
| 19717197 | Background | Pinkawa M, Attieh C, Piroth MD, Holy R, Nussen S, Klotz J, Hawickhorst R, Schafer W, Eble MJ. Dose-escalation using intensity-modulated radiotherapy for prostate cancer--evaluation of the dose distribution with and without 18F-choline PET-CT detected simultaneous integrated boost. Radiother Oncol. 2009 Nov;93(2):213-9. doi: 10.1016/j.radonc.2009.07.014. Epub 2009 Aug 28. |
| 22289620 | Background | Pinkawa M, Piroth MD, Holy R, Klotz J, Djukic V, Corral NE, Caffaro M, Winz OH, Krohn T, Mottaghy FM, Eble MJ. Dose-escalation using intensity-modulated radiotherapy for prostate cancer - evaluation of quality of life with and without (18)F-choline PET-CT detected simultaneous integrated boost. Radiat Oncol. 2012 Jan 30;7:14. doi: 10.1186/1748-717X-7-14. |
| 21477947 | Background | Wong WW, Schild SE, Vora SA, Ezzell GA, Nguyen BD, Ram PC, Roarke MC. Image-guided radiotherapy for prostate cancer: a prospective trial of concomitant boost using indium-111-capromab pendetide (ProstaScint) imaging. Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):e423-9. doi: 10.1016/j.ijrobp.2011.01.048. Epub 2011 Apr 7. |
| 17284381 | Background | Ellis RJ, Zhou H, Kim EY, Fu P, Kaminsky DA, Sodee B, Colussi V, Vance WZ, Spirnak JP, Kim C, Resnick MI. Biochemical disease-free survival rates following definitive low-dose-rate prostate brachytherapy with dose escalation to biologic target volumes identified with SPECT/CT capromab pendetide. Brachytherapy. 2007 Jan-Mar;6(1):16-25. doi: 10.1016/j.brachy.2006.11.002. |
| 19910135 | Background | Miralbell R, Molla M, Rouzaud M, Hidalgo A, Toscas JI, Lozano J, Sanz S, Ares C, Jorcano S, Linero D, Escude L. Hypofractionated boost to the dominant tumor region with intensity modulated stereotactic radiotherapy for prostate cancer: a sequential dose escalation pilot study. Int J Radiat Oncol Biol Phys. 2010 Sep 1;78(1):50-7. doi: 10.1016/j.ijrobp.2009.07.1689. Epub 2009 Nov 10. |
| 18407430 | Background | Fonteyne V, Villeirs G, Speleers B, De Neve W, De Wagter C, Lumen N, De Meerleer G. Intensity-modulated radiotherapy as primary therapy for prostate cancer: report on acute toxicity after dose escalation with simultaneous integrated boost to intraprostatic lesion. Int J Radiat Oncol Biol Phys. 2008 Nov 1;72(3):799-807. doi: 10.1016/j.ijrobp.2008.01.040. Epub 2008 Apr 11. |
| 15967524 | Background | De Meerleer G, Villeirs G, Bral S, Paelinck L, De Gersem W, Dekuyper P, De Neve W. The magnetic resonance detected intraprostatic lesion in prostate cancer: planning and delivery of intensity-modulated radiotherapy. Radiother Oncol. 2005 Jun;75(3):325-33. doi: 10.1016/j.radonc.2005.04.014. |
| 11038145 | Background | Zelefsky MJ, Cohen G, Zakian KL, Dyke J, Koutcher JA, Hricak H, Schwartz L, Zaider M. Intraoperative conformal optimization for transperineal prostate implantation using magnetic resonance spectroscopic imaging. Cancer J. 2000 Jul-Aug;6(4):249-55. |
| 10192361 | Background | Brenner DJ, Hall EJ. Fractionation and protraction for radiotherapy of prostate carcinoma. Int J Radiat Oncol Biol Phys. 1999 Mar 15;43(5):1095-101. doi: 10.1016/s0360-3016(98)00438-6. |
| 17448868 | Background | Williams SG, Taylor JM, Liu N, Tra Y, Duchesne GM, Kestin LL, Martinez A, Pratt GR, Sandler H. Use of individual fraction size data from 3756 patients to directly determine the alpha/beta ratio of prostate cancer. Int J Radiat Oncol Biol Phys. 2007 May 1;68(1):24-33. doi: 10.1016/j.ijrobp.2006.12.036. |
| 22652106 | Background | Vogelius IR, Bentzen SM. Meta-analysis of the alpha/beta ratio for prostate cancer in the presence of an overall time factor: bad news, good news, or no news? Int J Radiat Oncol Biol Phys. 2013 Jan 1;85(1):89-94. doi: 10.1016/j.ijrobp.2012.03.004. Epub 2012 May 30. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Clinical T stage | Clinical stage assessed by TNM ajcc seventh edition considering T2 less invasive than T3 | Count of Participants | Participants |
|
| Gleason group (ISUP 2014/WHO 2016) | Gleason group classification for prostate cancer were used considering Group 1 as less aggressive and Group 5 most aggressive | Count of Participants | Participants |
|
| Pre-treatment PSA (ng/ml) | Median | Inter-Quartile Range | ng/ml |
|
| Counts |
|---|
| Participants |
|
|
| Primary | Local Control | An image complete response was defined as disappearance of all morphological and functional lesions in mpMRI 6 to 9 months after radiotherapy. | Posted | Count of Participants | Participants | 6 and 9 months following radiotherapy |
|
|
|
| Primary | Acute and Late Rectal and Urinary Complications | Acute and late rectal and urinary complications defined as the number of participants with treatment-related adverse events assessed by Common Terminology Criteria for Adverse Events CTCAE v4.0 and Radiation- Therapy Oncology Group/ European Organization for Research and Treatment of Cancer RTOG/EORTC scales (been 0: no toxicity and 4: most severe toxicity). | Posted | Count of Participants | Participants | 5 years |
|
|
|
| Secondary | Number of Participants Free of Biochemical Progression | Biochemical disease-free survival according to the Phoenix definition (PSA >2 ng/mL above the currently observed PSA nadir. Defined as the time from enrollment to progression of biochemical disease, or death from any cause, or censoring at the date of the last contact. | Localized prostate cancer (PCa) of intermediate and high risk | Posted | Count of Participants | Participants | 5 years |
|
|
|
| Secondary | Quality of Life (QoL) Assessed by the Expanded Prostate Cancer Index Composite EPIC16 Scale 0-60 (Best to Worst). The Total Score of the Scale is the Summatory of the Domain's Score | Assessment of the QoL perceived by the patient in the urinary incontinence, urinary abstraction irritation, bowel function, sexual function and vitality/hormone functions domains | No clinical data were collected for this outcome. | Posted | 5 years |
|
|
| Secondary | Disease-free Survival (DFS) | Survival free of any event including biochemical failure, local failure, distant metastasis or death | Not Posted | 5 years | Participants |
| Secondary | Verification of Safety Margins | Quantification of the systematic and random errors during the preparation and administration of the radiotherapy treatment in 15 patients. Security margins estimation according to Van Herk formula | Not Posted | 5 years | Participants |
| 0 |
| 30 |
| 0 |
| 30 |
| 27 |
| 30 |
| Acute urinary toxicity | Renal and urinary disorders | Systematic Assessment |
|
| Late rectal toxicity | Gastrointestinal disorders | Systematic Assessment |
|
| Late urinary toxicity | Renal and urinary disorders | Systematic Assessment |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| Grade >2 |
|
| Acute urinary |
|
| Late rectal |
|
| Late urinary |
|