Skip to main content
Top
Published in: BMC Cancer 1/2012

Open Access 01-12-2012 | Study protocol

Hypofractionated helical intensity-modulated radiotherapy of the prostate bed after prostatectomy with or without the pelvic lymph nodes - the PRIAMOS trial

Authors: Sonja Krause, Florian Sterzing, Dirk Neuhof, Lutz Edler, Juergen Debus, Klaus Herfarth

Published in: BMC Cancer | Issue 1/2012

Login to get access

Abstract

Background

While evidence on safety and efficacy of primary hypofractionated radiotherapy in prostate cancer is accumulating, data on postoperative hypofractionated treatment of the prostate bed and of the pelvic lymph nodes is still scarce. This phase II trial was initiated to investigate safety and feasibility of hypofractionated treatment of the prostate bed alone or with the pelvic lymph nodes.

Methods/design

A total of 80 prostate cancer patients with the indication for adjuvant radiotherapy will be enrolled, where 40 patients with a low risk of lymph node involvement (arm 1) and another 40 patients with a high risk of lymph node involvement (arm 2) will each receive 54 Gy in 18 fractions to the prostate bed. Arm 2 will be given 45 Gy to the pelvic lymph nodes additionally. Helical Tomotherapy and daily image guidance will be used.

Discussion

This trial was initiated to substantiate data on hypofractionated treatment of the prostate bed and generate first data on adjuvant hypofractionated radiotherapy of the pelvic lymph nodes.

Trial registration

ClinicalTrials.gov; NCT01620710
Appendix
Available only for authorised users
Literature
1.
go back to reference Röllig C, Nothacker M: Interdisziplinäre Leitlinie der Qualität S3 zur Früherkennung, Diagnose und Therapie der verschiedenen Stadien des Prostatakarzinoms. Deutsche Gesellschaft für Urologie e.V. 2009 Röllig C, Nothacker M: Interdisziplinäre Leitlinie der Qualität S3 zur Früherkennung, Diagnose und Therapie der verschiedenen Stadien des Prostatakarzinoms. Deutsche Gesellschaft für Urologie e.V. 2009
2.
go back to reference Stephenson AJ, Scardino PT, Kattan MW, Pisansky TM, Slawin KM, Klein EA, Anscher MS, Michalski JM, Sandler HM, Lin DW, et al: Predicting the outcome of salvage radiation therapy for recurrent prostate cancer after radical prostatectomy. J Clin Oncol. 2007, 25: 2035-2041. 10.1200/JCO.2006.08.9607.CrossRefPubMedPubMedCentral Stephenson AJ, Scardino PT, Kattan MW, Pisansky TM, Slawin KM, Klein EA, Anscher MS, Michalski JM, Sandler HM, Lin DW, et al: Predicting the outcome of salvage radiation therapy for recurrent prostate cancer after radical prostatectomy. J Clin Oncol. 2007, 25: 2035-2041. 10.1200/JCO.2006.08.9607.CrossRefPubMedPubMedCentral
3.
go back to reference Bolla M, van Poppel H, Collette L, van Cangh P, Vekemans K, Da Pozzo L, de Reijke TM, Verbaeys A, Bosset JF, van Velthoven R, et al: Postoperative radiotherapy after radical prostatectomy: a randomised controlled trial (EORTC trial 22911). Lancet. 2005, 366: 572-578. 10.1016/S0140-6736(05)67101-2.CrossRefPubMed Bolla M, van Poppel H, Collette L, van Cangh P, Vekemans K, Da Pozzo L, de Reijke TM, Verbaeys A, Bosset JF, van Velthoven R, et al: Postoperative radiotherapy after radical prostatectomy: a randomised controlled trial (EORTC trial 22911). Lancet. 2005, 366: 572-578. 10.1016/S0140-6736(05)67101-2.CrossRefPubMed
4.
go back to reference Thompson IM, Tangen CM, Paradelo J, Lucia MS, Miller G, Troyer D, Messing E, Forman J, Chin J, Swanson G, et al: Adjuvant radiotherapy for pathologically advanced prostate cancer: a randomized clinical trial. JAMA. 2006, 296: 2329-2335. 10.1001/jama.296.19.2329.CrossRefPubMed Thompson IM, Tangen CM, Paradelo J, Lucia MS, Miller G, Troyer D, Messing E, Forman J, Chin J, Swanson G, et al: Adjuvant radiotherapy for pathologically advanced prostate cancer: a randomized clinical trial. JAMA. 2006, 296: 2329-2335. 10.1001/jama.296.19.2329.CrossRefPubMed
5.
go back to reference Wiegel T, Bottke D, Steiner U, Siegmann A, Golz R, Storkel S, Willich N, Semjonow A, Souchon R, Stockle M, et al: Phase III postoperative adjuvant radiotherapy after radical prostatectomy compared with radical prostatectomy alone in pT3 prostate cancer with postoperative undetectable prostate-specific antigen: ARO 96-02/AUO AP 09/95. J Clin Oncol. 2009, 27: 2924-2930. 10.1200/JCO.2008.18.9563.CrossRefPubMed Wiegel T, Bottke D, Steiner U, Siegmann A, Golz R, Storkel S, Willich N, Semjonow A, Souchon R, Stockle M, et al: Phase III postoperative adjuvant radiotherapy after radical prostatectomy compared with radical prostatectomy alone in pT3 prostate cancer with postoperative undetectable prostate-specific antigen: ARO 96-02/AUO AP 09/95. J Clin Oncol. 2009, 27: 2924-2930. 10.1200/JCO.2008.18.9563.CrossRefPubMed
6.
go back to reference Thompson IM, Tangen CM, Paradelo J, Lucia MS, Miller G, Troyer D, Messing E, Forman J, Chin J, Swanson G, et al: Adjuvant radiotherapy for pathological T3N0M0 prostate cancer significantly reduces risk of metastases and improves survival: long-term followup of a randomized clinical trial. J Urol. 2009, 181: 956-962. 10.1016/j.juro.2008.11.032.CrossRefPubMedPubMedCentral Thompson IM, Tangen CM, Paradelo J, Lucia MS, Miller G, Troyer D, Messing E, Forman J, Chin J, Swanson G, et al: Adjuvant radiotherapy for pathological T3N0M0 prostate cancer significantly reduces risk of metastases and improves survival: long-term followup of a randomized clinical trial. J Urol. 2009, 181: 956-962. 10.1016/j.juro.2008.11.032.CrossRefPubMedPubMedCentral
7.
go back to reference Roach M, DeSilvio M, Lawton C, Uhl V, Machtay M, Seider MJ, Rotman M, Jones C, Asbell SO, Valicenti RK, et al: Phase III trial comparing whole-pelvic versus prostate-only radiotherapy and neoadjuvant versus adjuvant combined androgen suppression: Radiation Therapy Oncology Group 9413. J Clin Oncol. 2003, 21: 1904-1911. 10.1200/JCO.2003.05.004.CrossRefPubMed Roach M, DeSilvio M, Lawton C, Uhl V, Machtay M, Seider MJ, Rotman M, Jones C, Asbell SO, Valicenti RK, et al: Phase III trial comparing whole-pelvic versus prostate-only radiotherapy and neoadjuvant versus adjuvant combined androgen suppression: Radiation Therapy Oncology Group 9413. J Clin Oncol. 2003, 21: 1904-1911. 10.1200/JCO.2003.05.004.CrossRefPubMed
8.
go back to reference Asbell SO, Martz KL, Shin KH, Sause WT, Doggett RL, Perez CA, Pilepich MV: Impact of surgical staging in evaluating the radiotherapeutic outcome in RTOG #77-06, a phase III study for T1BN0M0 (A2) and T2N0M0 (B) prostate carcinoma. Int J Radiat Oncol Biol Phys. 1998, 40: 769-782. 10.1016/S0360-3016(97)00926-7.CrossRefPubMed Asbell SO, Martz KL, Shin KH, Sause WT, Doggett RL, Perez CA, Pilepich MV: Impact of surgical staging in evaluating the radiotherapeutic outcome in RTOG #77-06, a phase III study for T1BN0M0 (A2) and T2N0M0 (B) prostate carcinoma. Int J Radiat Oncol Biol Phys. 1998, 40: 769-782. 10.1016/S0360-3016(97)00926-7.CrossRefPubMed
9.
go back to reference Pommier P, Chabaud S, Lagrange JL, Richaud P, Lesaunier F, Le Prise E, Wagner JP, Hay MH, Beckendorf V, Suchaud JP, et al: Is there a role for pelvic irradiation in localized prostate adenocarcinoma? Preliminary results of GETUG-01. J Clin Oncol. 2007, 25: 5366-5373. 10.1200/JCO.2006.10.5171.CrossRefPubMed Pommier P, Chabaud S, Lagrange JL, Richaud P, Lesaunier F, Le Prise E, Wagner JP, Hay MH, Beckendorf V, Suchaud JP, et al: Is there a role for pelvic irradiation in localized prostate adenocarcinoma? Preliminary results of GETUG-01. J Clin Oncol. 2007, 25: 5366-5373. 10.1200/JCO.2006.10.5171.CrossRefPubMed
10.
go back to reference Spiotto MT, Hancock SL, King CR: Radiotherapy after prostatectomy: improved biochemical relapse-free survival with whole pelvic compared with prostate bed only for high-risk patients. Int J Radiat Oncol Biol Phys. 2007, 69: 54-61. 10.1016/j.ijrobp.2007.02.035.CrossRefPubMed Spiotto MT, Hancock SL, King CR: Radiotherapy after prostatectomy: improved biochemical relapse-free survival with whole pelvic compared with prostate bed only for high-risk patients. Int J Radiat Oncol Biol Phys. 2007, 69: 54-61. 10.1016/j.ijrobp.2007.02.035.CrossRefPubMed
11.
go back to reference Fowler JF: The radiobiology of prostate cancer including new aspects of fractionated radiotherapy. Acta Oncol. 2005, 44: 265-276. 10.1080/02841860410002824.CrossRefPubMed Fowler JF: The radiobiology of prostate cancer including new aspects of fractionated radiotherapy. Acta Oncol. 2005, 44: 265-276. 10.1080/02841860410002824.CrossRefPubMed
12.
go back to reference Kupelian PA, Willoughby TR, Reddy CA, Klein EA, Mahadevan A: Hypofractionated intensity-modulated radiotherapy (70 Gy at 2.5 Gy per fraction) for localized prostate cancer: Cleveland Clinic experience. Int J Radiat Oncol Biol Phys. 2007, 68: 1424-1430. 10.1016/j.ijrobp.2007.01.067.CrossRefPubMed Kupelian PA, Willoughby TR, Reddy CA, Klein EA, Mahadevan A: Hypofractionated intensity-modulated radiotherapy (70 Gy at 2.5 Gy per fraction) for localized prostate cancer: Cleveland Clinic experience. Int J Radiat Oncol Biol Phys. 2007, 68: 1424-1430. 10.1016/j.ijrobp.2007.01.067.CrossRefPubMed
13.
go back to reference Arcangeli G, Saracino B, Gomellini S, Petrongari MG, Arcangeli S, Sentinelli S, Marzi S, Landoni V, Fowler J, Strigari L: A prospective phase III randomized trial of hypofractionation versus conventional fractionation in patients with high-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2010, 78: 11-18. 10.1016/j.ijrobp.2009.07.1691.CrossRefPubMed Arcangeli G, Saracino B, Gomellini S, Petrongari MG, Arcangeli S, Sentinelli S, Marzi S, Landoni V, Fowler J, Strigari L: A prospective phase III randomized trial of hypofractionation versus conventional fractionation in patients with high-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2010, 78: 11-18. 10.1016/j.ijrobp.2009.07.1691.CrossRefPubMed
14.
go back to reference Yeoh EE, Botten RJ, Butters J, Di Matteo AC, Holloway RH, Fowler J: Hypofractionated versus conventionally fractionated radiotherapy for prostate carcinoma: final results of phase III randomized trial. Int J Radiat Oncol Biol Phys. 2011, 81: 1271-1278. 10.1016/j.ijrobp.2010.07.1984.CrossRefPubMed Yeoh EE, Botten RJ, Butters J, Di Matteo AC, Holloway RH, Fowler J: Hypofractionated versus conventionally fractionated radiotherapy for prostate carcinoma: final results of phase III randomized trial. Int J Radiat Oncol Biol Phys. 2011, 81: 1271-1278. 10.1016/j.ijrobp.2010.07.1984.CrossRefPubMed
15.
go back to reference Kruser TJ, Jarrard DF, Graf AK, Hedican SP, Paolone DR, Wegenke JD, Liu G, Geye HM, Ritter MA: Early hypofractionated salvage radiotherapy for postprostatectomy biochemical recurrence. Cancer. 2011, 117: 2629-2636. 10.1002/cncr.25824.CrossRefPubMed Kruser TJ, Jarrard DF, Graf AK, Hedican SP, Paolone DR, Wegenke JD, Liu G, Geye HM, Ritter MA: Early hypofractionated salvage radiotherapy for postprostatectomy biochemical recurrence. Cancer. 2011, 117: 2629-2636. 10.1002/cncr.25824.CrossRefPubMed
16.
go back to reference Guckenberger M, Flentje M: Intensity-modulated radiotherapy (IMRT) of localized prostate cancer: a review and future perspectives. Strahlenther Onkol. 2007, 183: 57-62. 10.1007/s00066-007-1631-3.CrossRefPubMed Guckenberger M, Flentje M: Intensity-modulated radiotherapy (IMRT) of localized prostate cancer: a review and future perspectives. Strahlenther Onkol. 2007, 183: 57-62. 10.1007/s00066-007-1631-3.CrossRefPubMed
17.
go back to reference Zelefsky MJ, Fuks Z, Leibel SA: Intensity-modulated radiation therapy for prostate cancer. Semin Radiat Oncol. 2002, 12: 229-237. 10.1053/srao.2002.00000.CrossRefPubMed Zelefsky MJ, Fuks Z, Leibel SA: Intensity-modulated radiation therapy for prostate cancer. Semin Radiat Oncol. 2002, 12: 229-237. 10.1053/srao.2002.00000.CrossRefPubMed
18.
go back to reference Mackie TR, Balog J, Ruchala K, Shepard D, Aldridge S, Fitchard E, Reckwerdt P, Olivera G, McNutt T, Mehta M: Tomotherapy. Semin Radiat Oncol. 1999, 9: 108-117. 10.1016/S1053-4296(99)80058-7.CrossRefPubMed Mackie TR, Balog J, Ruchala K, Shepard D, Aldridge S, Fitchard E, Reckwerdt P, Olivera G, McNutt T, Mehta M: Tomotherapy. Semin Radiat Oncol. 1999, 9: 108-117. 10.1016/S1053-4296(99)80058-7.CrossRefPubMed
19.
go back to reference Sterzing F, Schubert K, Sroka-Perez G, Kalz J, Debus J, Herfarth K: Helical tomotherapy. Experiences of the first 150 patients in Heidelberg. Strahlenther Onkol. 2008, 184: 8-14. 10.1007/s00066-008-1778-6.CrossRefPubMed Sterzing F, Schubert K, Sroka-Perez G, Kalz J, Debus J, Herfarth K: Helical tomotherapy. Experiences of the first 150 patients in Heidelberg. Strahlenther Onkol. 2008, 184: 8-14. 10.1007/s00066-008-1778-6.CrossRefPubMed
20.
go back to reference Roach M, Marquez C, Yuo HS, Narayan P, Coleman L, Nseyo UO, Navvab Z, Carroll PR: Predicting the risk of lymph node involvement using the pre-treatment prostate specific antigen and Gleason score in men with clinically localized prostate cancer. Int J Radiat Oncol Biol Phys. 1994, 28: 33-37. 10.1016/0360-3016(94)90138-4.CrossRefPubMed Roach M, Marquez C, Yuo HS, Narayan P, Coleman L, Nseyo UO, Navvab Z, Carroll PR: Predicting the risk of lymph node involvement using the pre-treatment prostate specific antigen and Gleason score in men with clinically localized prostate cancer. Int J Radiat Oncol Biol Phys. 1994, 28: 33-37. 10.1016/0360-3016(94)90138-4.CrossRefPubMed
21.
go back to reference A'Hern RP: Sample size tables for exact single-stage phase II designs. Stat Med. 2001, 20: 859-866. 10.1002/sim.721.CrossRefPubMed A'Hern RP: Sample size tables for exact single-stage phase II designs. Stat Med. 2001, 20: 859-866. 10.1002/sim.721.CrossRefPubMed
22.
go back to reference Lawton CA, Michalski J, El-Naqa I, Byyounouski MK, Lee WR, Menard C, O’Meara E, Rosenthal SA, Ritter M, Seider M: RTOG GU Radiation oncology specialists reach consensus on pelvic lymph node volumes for high-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2009, 74: 383-387. 10.1016/j.ijrobp.2008.08.002.CrossRefPubMed Lawton CA, Michalski J, El-Naqa I, Byyounouski MK, Lee WR, Menard C, O’Meara E, Rosenthal SA, Ritter M, Seider M: RTOG GU Radiation oncology specialists reach consensus on pelvic lymph node volumes for high-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2009, 74: 383-387. 10.1016/j.ijrobp.2008.08.002.CrossRefPubMed
23.
go back to reference Martin JM, Rosewall T, Bayley A, Bristow R, Chung P, Crook J, Gospodarowicz M, McLean M, Menard C, Milosevic M, et al: Phase II trial of hypofractionated image-guided intensity-modulated radiotherapy for localized prostate adenocarcinoma. Int J Radiat Oncol Biol Phys. 2007, 69: 1084-1089. 10.1016/j.ijrobp.2007.04.049.CrossRefPubMed Martin JM, Rosewall T, Bayley A, Bristow R, Chung P, Crook J, Gospodarowicz M, McLean M, Menard C, Milosevic M, et al: Phase II trial of hypofractionated image-guided intensity-modulated radiotherapy for localized prostate adenocarcinoma. Int J Radiat Oncol Biol Phys. 2007, 69: 1084-1089. 10.1016/j.ijrobp.2007.04.049.CrossRefPubMed
24.
go back to reference Cozzarini C, Fiorino C, Di Muzio N, Valdagni R, Salonia A, Alongi F, Broggi S, Guazzoni G, Montorsi F, Rigatti P, et al: Hypofractionated adjuvant radiotherapy with helical tomotherapy after radical prostatectomy: planning data and toxicity results of a Phase I-II study. Radiother Oncol. 2008, 88: 26-33. 10.1016/j.radonc.2008.03.021.CrossRefPubMed Cozzarini C, Fiorino C, Di Muzio N, Valdagni R, Salonia A, Alongi F, Broggi S, Guazzoni G, Montorsi F, Rigatti P, et al: Hypofractionated adjuvant radiotherapy with helical tomotherapy after radical prostatectomy: planning data and toxicity results of a Phase I-II study. Radiother Oncol. 2008, 88: 26-33. 10.1016/j.radonc.2008.03.021.CrossRefPubMed
25.
go back to reference Adkison JB, McHaffie DR, Bentzen SM, Patel RR, Khuntia D, Petereit DG, Hong TS, Tome W, Ritter MA: Phase I trial of pelvic nodal dose escalation with hypofractionated IMRT for high-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2012, 82: 184-190. 10.1016/j.ijrobp.2010.09.018.CrossRefPubMed Adkison JB, McHaffie DR, Bentzen SM, Patel RR, Khuntia D, Petereit DG, Hong TS, Tome W, Ritter MA: Phase I trial of pelvic nodal dose escalation with hypofractionated IMRT for high-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2012, 82: 184-190. 10.1016/j.ijrobp.2010.09.018.CrossRefPubMed
Metadata
Title
Hypofractionated helical intensity-modulated radiotherapy of the prostate bed after prostatectomy with or without the pelvic lymph nodes - the PRIAMOS trial
Authors
Sonja Krause
Florian Sterzing
Dirk Neuhof
Lutz Edler
Juergen Debus
Klaus Herfarth
Publication date
01-12-2012
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2012
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/1471-2407-12-504

Other articles of this Issue 1/2012

BMC Cancer 1/2012 Go to the issue
Webinar | 19-02-2024 | 17:30 (CET)

Keynote webinar | Spotlight on antibody–drug conjugates in cancer

Antibody–drug conjugates (ADCs) are novel agents that have shown promise across multiple tumor types. Explore the current landscape of ADCs in breast and lung cancer with our experts, and gain insights into the mechanism of action, key clinical trials data, existing challenges, and future directions.

Dr. Véronique Diéras
Prof. Fabrice Barlesi
Developed by: Springer Medicine