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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05781217
Other study ID # URONCOR 06-24
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date March 14, 2023
Est. completion date December 2032

Study information

Verified date November 2023
Source Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic
Contact Pablo Raña, PhD
Phone 0034696633409
Email investigacion@seor.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The optimal indication for ADT has long been a point of controversy, at least until the results of randomised trials comparing RT with and without ADT were published. NCCN guidelines and most retrospective series and left the decision to prescribe ADT in combination with RT to the discretion of the treating physician, despite a lack of clear scientific evidence to support this recommendation. The percentage of patients in those retrospective series who received hormone therapy ranged from 33% to 71%, but generally involved patients with adverse prognostic factors (Gleason score > 7, stage pT3-T4, PSA > 1 ng/mL in cases with biochemical recurrence [BCR], and PSA doubling time [PSA-DT] < 6 months). Despite the heterogeneity in those studies in terms of treatment duration, RT dose, and treatment volumes, most of the studies found that ADT significantly prolonged biochemical relapse-free survival (BRFS), especially in patients with PSA levels > 1 ng/mL at recurrence. The results of two randomised trials evaluating SRT with or without ADT were published in 2017, with both trials demonstrating a benefit for ADT in this clinical setting. A follow-up study confirmed the value of ADT in combination with SRT in terms of better PFS and, in the RTOG study, an improvement in overall survival (OS). Despite the lack of data from phase III trials regarding the influence of PSA-DT, the BRFS interval, and the Gleason score in terms of their effects on the clinical course of patients who develop BCR, there is strong evidence from other studies to support the use of these variables (together with age and comorbidities). Given the available evidence, we believe that these variables should be considered when determining the indications for ADT. In line with the philosophy underlying the approach used by D'Amico to develop a risk classification system for prostate cancer patients at diagnosis, we propose three risk groups. According to Pollack et al. and Spratt et al., low-risk patients would not benefit from hormone therapy, especially long-term ADT, due to the deleterious effects of such treatment. By contrast, intermediate and high risk patients would be candidates for ADT combined with RT. However, the optimal duration of ADT in these patients (6 months vs. 2 years) remains undefined and needs to be determined prospectively in a randomised trial, similar to the approach used in the DART 05.01 trial. SRT and ADT are widely used in routine clinical practice to treat patients who develop BCR after prostatectomy. In this context, we intend to perform a multicentre, phase III trial to define the optimal duration of ADT (6 vs. 24 months).


Recruitment information / eligibility

Status Recruiting
Enrollment 534
Est. completion date December 2032
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Patients with histologically-confirmed prostate cancer treated with radical prostatectomy. Patients who have not undergone lymph node dissection are eligible for inclusion. 2. Biochemical recurrence after prostatectomy: BCR is defined as a PSA value = 0.2 ng/mL, with at least one confirmatory PSA determination = two weeks after the first test (the confirmatory PSA level must be higher than the initial value). Patients with Gleason 8-10, pT3b or R1 are eligible for inclusion in the trial with PSA = 0.15 ng/mL; however, in patients with PSA > 0.4 ng/mL, imaging tests (conventional CT and bone scans or advanced imaging techniques such as PSMA or choline PET/CT) should be performed to check for metastases. In patients with PSA levels between 0.15 and 0.4 ng/mL, no further tests are required to check for distant metastases prior to inclusion. 3. Intermediate and high-risk patients according to the classification criteria proposed by González San Segundo et al. (18): CHARACTERISTICS INTERMEDIATE RISK (= 2) HIGH RISK(= 1) PSA at diagnosis, ng/mL 0.6-1.0 =1.0 PSA doubling time, months 6-12 < 6 GLEASON / ISUP 7/3 =8/=4 TNM (prostatectomy specimen) pT2-3a pN0-Mx pT3b pN0-Mx Time to biochemical recurrence, months >18 <18 Margins Positive Positive 4. Testosterone level > 150 ng/dL at inclusion 5. ECOG 0-1 6. Life expectancy > 5 years 7. Signed informed consent Exclusion Criteria: 1. Presence of pN1 disease in the original surgical specimen 2. Presence of macroscopic disease on imaging tests. If the PSA at diagnosis is > 0.4 ng/mL, then imaging tests (CT and bone scan and/or PET/CT or body magnetic resonance imaging [MRI]) are required. 3. PSA <0.2 or <0.15 ng/mL (if Gleason score=10, pT3b, or R1 in the radical prostatectomy specimen). 4. Previous pelvic radiotherapy 5. Radiotherapy contraindicated 6. Ongoing treatment with ADT or PSA-modulating drugs (e.g., finasteride, dutasteride, high dose steroids) 7. Inability to understand the treatment protocol or sign informed consent

Study Design


Intervention

Drug:
triptorelin, goserelin, leuprorelin
ADT will consist of LHRH analogues (triptorelin, goserelin, leuprorelin) with bicalutamide 50 mg/day started 10 days before the first ADT injection to avoid LHRH-related flare-ups. Bicalutamide will be discontinued after 30 days. The LHRH analogue will be initiated prior to the start of radiotherapy and administered for 6 or 24 months depending on treatment allocation. The maximum time permitted between randomisation and administration of the first LHRH dose is 30 days. The maximum time from the first LHRH dose to the start of SRT is 60 days.

Locations

Country Name City State
Spain Hospital de Cruces Baracaldo Vizcaya
Spain Hospital Clinic de Barcelona Barcelona
Spain Hospital de la Santa Creu i Sant Pau Barcelona
Spain Hospital Universitario Vall d'Hebron Barcelona
Spain Hospital Universitario de Fuenlabrada Fuenlabrada Madrid
Spain Instituto Catalán de Oncología Hospitalet L'Hospitalet de Llobregat Barcelona
Spain Hospital Clínico San Carlos Madrid
Spain Hospital Gregorio Marañón Madrid
Spain Hospital Ramón y Cajal Madrid
Spain Hospital Ruber Internacional Madrid
Spain Hospital San Francisco de Asís Madrid
Spain Hospital Universitario de La Paz Madrid
Spain Hospital Universitario Fundación Jiménez Díaz Madrid
Spain Hospital Universitario HM Sanchinarro Madrid
Spain Hospital Universitario Quirón Madrid Pozuelo De Alarcón Madrid
Spain Hospital Universitario Sant Joan de Reus Tarragona
Spain Hospital Universitario y Politécnico de La Fe Valencia

Sponsors (1)

Lead Sponsor Collaborator
Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic

Country where clinical trial is conducted

Spain, 

References & Publications (24)

Carrie C, Hasbini A, de Laroche G, Richaud P, Guerif S, Latorzeff I, Supiot S, Bosset M, Lagrange JL, Beckendorf V, Lesaunier F, Dubray B, Wagner JP, N'Guyen TD, Suchaud JP, Crehange G, Barbier N, Habibian M, Ferlay C, Fourneret P, Ruffion A, Dussart S. Salvage radiotherapy with or without short-term hormone therapy for rising prostate-specific antigen concentration after radical prostatectomy (GETUG-AFU 16): a randomised, multicentre, open-label phase 3 trial. Lancet Oncol. 2016 Jun;17(6):747-756. doi: 10.1016/S1470-2045(16)00111-X. Epub 2016 May 6. Erratum In: Lancet Oncol. 2016 Jun;17 (6):e223. Lancet Oncol. 2019 Jun;20(6):e293. — View Citation

Carrie C, Magne N, Burban-Provost P, Sargos P, Latorzeff I, Lagrange JL, Supiot S, Belkacemi Y, Peiffert D, Allouache N, Dubray BM, Servagi-Vernat S, Suchaud JP, Crehange G, Guerif S, Brihoum M, Barbier N, Graff-Cailleaud P, Ruffion A, Dussart S, Ferlay C, Chabaud S. Short-term androgen deprivation therapy combined with radiotherapy as salvage treatment after radical prostatectomy for prostate cancer (GETUG-AFU 16): a 112-month follow-up of a phase 3, randomised trial. Lancet Oncol. 2019 Dec;20(12):1740-1749. doi: 10.1016/S1470-2045(19)30486-3. Epub 2019 Oct 16. — View Citation

Dess RT, Sun Y, Jackson WC, Jairath NK, Kishan AU, Wallington DG, Mahal BA, Stish BJ, Zumsteg ZS, Den RB, Hall WA, Gharzai LA, Jaworski EM, Reichert ZR, Morgan TM, Mehra R, Schaeffer EM, Sartor O, Nguyen PL, Lee WR, Rosenthal SA, Michalski JM, Schipper MJ, Dignam JJ, Pisansky TM, Zietman AL, Sandler HM, Efstathiou JA, Feng FY, Shipley WU, Spratt DE. Association of Presalvage Radiotherapy PSA Levels After Prostatectomy With Outcomes of Long-term Antiandrogen Therapy in Men With Prostate Cancer. JAMA Oncol. 2020 May 1;6(5):735-743. doi: 10.1001/jamaoncol.2020.0109. — View Citation

Fossati N, Karnes RJ, Boorjian SA, Moschini M, Morlacco A, Bossi A, Seisen T, Cozzarini C, Fiorino C, Noris Chiorda B, Gandaglia G, Dell'Oglio P, Joniau S, Tosco L, Shariat S, Goldner G, Hinkelbein W, Bartkowiak D, Haustermans K, Tombal B, Montorsi F, Van Poppel H, Wiegel T, Briganti A. Long-term Impact of Adjuvant Versus Early Salvage Radiation Therapy in pT3N0 Prostate Cancer Patients Treated with Radical Prostatectomy: Results from a Multi-institutional Series. Eur Urol. 2017 Jun;71(6):886-893. doi: 10.1016/j.eururo.2016.07.028. Epub 2016 Jul 30. — View Citation

Fossati N, Robesti D, Karnes RJ, Soligo M, Boorjian SA, Bossi A, Coraggio G, Di Muzio N, Cozzarini C, Noris Chiorda B, Gandaglia G, Scarcella S, Bartkowiak D, Bohmer D, Shariat S, Goldner G, Battaglia A, Joniau S, Haustermans K, De Meerleer G, Fonteyne V, Ost P, Van Poppel H, Montorsi F, Wiegel T, Briganti A. Assessing the Role and Optimal Duration of Hormonal Treatment in Association with Salvage Radiation Therapy After Radical Prostatectomy: Results from a Multi-Institutional Study. Eur Urol. 2019 Oct;76(4):443-449. doi: 10.1016/j.eururo.2019.02.004. Epub 2019 Feb 22. — View Citation

Gonzalez-San Segundo C, Counago F, Gomez-Iturriaga A. Androgen Deprivation Therapy and Salvage Radiotherapy: Are We Missing Something? Eur Urol. 2019 Aug;76(2):260-261. doi: 10.1016/j.eururo.2019.01.045. Epub 2019 Feb 8. No abstract available. — View Citation

Jackson WC, Schipper MJ, Johnson SB, Foster C, Li D, Sandler HM, Palapattu GS, Hamstra DA, Feng FY. Duration of Androgen Deprivation Therapy Influences Outcomes for Patients Receiving Radiation Therapy Following Radical Prostatectomy. Eur Urol. 2016 Jan;69(1):50-7. doi: 10.1016/j.eururo.2015.05.009. Epub 2015 May 21. — View Citation

Jia ZW, Chang K, Dai B, Kong YY, Wang Y, Qu YY, Zhu YP, Ye DW. Factors influencing biochemical recurrence in patients who have received salvage radiotherapy after radical prostatectomy: a systematic review and meta-analysis. Asian J Androl. 2017 Jul-Aug;19(4):493-499. doi: 10.4103/1008-682X.179531. — View Citation

Kneebone A, Fraser-Browne C, Duchesne GM, Fisher R, Frydenberg M, Herschtal A, Williams SG, Brown C, Delprado W, Haworth A, Joseph DJ, Martin JM, Matthews JHL, Millar JL, Sidhom M, Spry N, Tang CI, Turner S, Wiltshire KL, Woo HH, Davis ID, Lim TS, Pearse M. Adjuvant radiotherapy versus early salvage radiotherapy following radical prostatectomy (TROG 08.03/ANZUP RAVES): a randomised, controlled, phase 3, non-inferiority trial. Lancet Oncol. 2020 Oct;21(10):1331-1340. doi: 10.1016/S1470-2045(20)30456-3. — View Citation

Lieng H, Hayden AJ, Christie DRH, Davis BJ, Eade TN, Emmett L, Holt T, Hruby G, Pryor D, Shakespeare TP, Sidhom M, Skala M, Wiltshire K, Yaxley J, Kneebone A. Radiotherapy for recurrent prostate cancer: 2018 Recommendations of the Australian and New Zealand Radiation Oncology Genito-Urinary group. Radiother Oncol. 2018 Nov;129(2):377-386. doi: 10.1016/j.radonc.2018.06.027. Epub 2018 Jul 20. — View Citation

Michalski JM, Lawton C, El Naqa I, Ritter M, O'Meara E, Seider MJ, Lee WR, Rosenthal SA, Pisansky T, Catton C, Valicenti RK, Zietman AL, Bosch WR, Sandler H, Buyyounouski MK, Menard C. Development of RTOG consensus guidelines for the definition of the clinical target volume for postoperative conformal radiation therapy for prostate cancer. Int J Radiat Oncol Biol Phys. 2010 Feb 1;76(2):361-8. doi: 10.1016/j.ijrobp.2009.02.006. Epub 2009 Apr 23. — View Citation

Parker CC, Clarke NW, Cook AD, Kynaston HG, Petersen PM, Catton C, Cross W, Logue J, Parulekar W, Payne H, Persad R, Pickering H, Saad F, Anderson J, Bahl A, Bottomley D, Brasso K, Chahal R, Cooke PW, Eddy B, Gibbs S, Goh C, Gujral S, Heath C, Henderson A, Jaganathan R, Jakobsen H, James ND, Kanaga Sundaram S, Lees K, Lester J, Lindberg H, Money-Kyrle J, Morris S, O'Sullivan J, Ostler P, Owen L, Patel P, Pope A, Popert R, Raman R, Roder MA, Sayers I, Simms M, Wilson J, Zarkar A, Parmar MKB, Sydes MR. Timing of radiotherapy after radical prostatectomy (RADICALS-RT): a randomised, controlled phase 3 trial. Lancet. 2020 Oct 31;396(10260):1413-1421. doi: 10.1016/S0140-6736(20)31553-1. Epub 2020 Sep 28. — View Citation

Pollack A, Karrison TG, Balogh AG, Gomella LG, Low DA, Bruner DW, Wefel JS, Martin AG, Michalski JM, Angyalfi SJ, Lukka H, Faria SL, Rodrigues GB, Beauchemin MC, Lee RJ, Seaward SA, Allen AM, Monitto DC, Seiferheld W, Sartor O, Feng F, Sandler HM. The addition of androgen deprivation therapy and pelvic lymph node treatment to prostate bed salvage radiotherapy (NRG Oncology/RTOG 0534 SPPORT): an international, multicentre, randomised phase 3 trial. Lancet. 2022 May 14;399(10338):1886-1901. doi: 10.1016/S0140-6736(21)01790-6. — View Citation

Poortmans P, Bossi A, Vandeputte K, Bosset M, Miralbell R, Maingon P, Boehmer D, Budiharto T, Symon Z, van den Bergh AC, Scrase C, Van Poppel H, Bolla M; EORTC Radiation Oncology Group. Guidelines for target volume definition in post-operative radiotherapy for prostate cancer, on behalf of the EORTC Radiation Oncology Group. Radiother Oncol. 2007 Aug;84(2):121-7. doi: 10.1016/j.radonc.2007.07.017. Epub 2007 Aug 13. — View Citation

Robin S, Jolicoeur M, Palumbo S, Zilli T, Crehange G, De Hertogh O, Derashodian T, Sargos P, Salembier C, Supiot S, Udrescu C, Chapet O. Prostate Bed Delineation Guidelines for Postoperative Radiation Therapy: On Behalf Of The Francophone Group of Urological Radiation Therapy. Int J Radiat Oncol Biol Phys. 2021 Apr 1;109(5):1243-1253. doi: 10.1016/j.ijrobp.2020.11.010. Epub 2020 Nov 10. — View Citation

Sargos P, Chabaud S, Latorzeff I, Magne N, Benyoucef A, Supiot S, Pasquier D, Abdiche MS, Gilliot O, Graff-Cailleaud P, Silva M, Bergerot P, Baumann P, Belkacemi Y, Azria D, Brihoum M, Soulie M, Richaud P. Adjuvant radiotherapy versus early salvage radiotherapy plus short-term androgen deprivation therapy in men with localised prostate cancer after radical prostatectomy (GETUG-AFU 17): a randomised, phase 3 trial. Lancet Oncol. 2020 Oct;21(10):1341-1352. doi: 10.1016/S1470-2045(20)30454-X. — View Citation

Shipley WU, Seiferheld W, Lukka HR, Major PP, Heney NM, Grignon DJ, Sartor O, Patel MP, Bahary JP, Zietman AL, Pisansky TM, Zeitzer KL, Lawton CA, Feng FY, Lovett RD, Balogh AG, Souhami L, Rosenthal SA, Kerlin KJ, Dignam JJ, Pugh SL, Sandler HM; NRG Oncology RTOG. Radiation with or without Antiandrogen Therapy in Recurrent Prostate Cancer. N Engl J Med. 2017 Feb 2;376(5):417-428. doi: 10.1056/NEJMoa1607529. — View Citation

Sidhom MA, Kneebone AB, Lehman M, Wiltshire KL, Millar JL, Mukherjee RK, Shakespeare TP, Tai KH. Post-prostatectomy radiation therapy: consensus guidelines of the Australian and New Zealand Radiation Oncology Genito-Urinary Group. Radiother Oncol. 2008 Jul;88(1):10-9. doi: 10.1016/j.radonc.2008.05.006. Epub 2008 May 29. — View Citation

Spratt DE, Dess RT, Zumsteg ZS, Lin DW, Tran PT, Morgan TM, Antonarakis ES, Nguyen PL, Ryan CJ, Sandler HM, Cooperberg MR, Posadas E, Feng FY. A Systematic Review and Framework for the Use of Hormone Therapy with Salvage Radiation Therapy for Recurrent Prostate Cancer. Eur Urol. 2018 Feb;73(2):156-165. doi: 10.1016/j.eururo.2017.06.027. Epub 2017 Jul 14. — View Citation

Vale CL, Fisher D, Kneebone A, Parker C, Pearse M, Richaud P, Sargos P, Sydes MR, Brawley C, Brihoum M, Brown C, Chabaud S, Cook A, Forcat S, Fraser-Browne C, Latorzeff I, Parmar MKB, Tierney JF; ARTISTIC Meta-analysis Group. Adjuvant or early salvage radiotherapy for the treatment of localised and locally advanced prostate cancer: a prospectively planned systematic review and meta-analysis of aggregate data. Lancet. 2020 Oct 31;396(10260):1422-1431. doi: 10.1016/S0140-6736(20)31952-8. Epub 2020 Sep 28. — View Citation

Valicenti RK, Thompson I Jr, Albertsen P, Davis BJ, Goldenberg SL, Wolf JS, Sartor O, Klein E, Hahn C, Michalski J, Roach M 3rd, Faraday MM; American Society for Radiation Oncology/American Urological Association. Adjuvant and salvage radiation therapy after prostatectomy: American Society for Radiation Oncology/American Urological Association guidelines. Int J Radiat Oncol Biol Phys. 2013 Aug 1;86(5):822-8. doi: 10.1016/j.ijrobp.2013.05.029. — View Citation

Van den Broeck T, van den Bergh RCN, Arfi N, Gross T, Moris L, Briers E, Cumberbatch M, De Santis M, Tilki D, Fanti S, Fossati N, Gillessen S, Grummet JP, Henry AM, Lardas M, Liew M, Rouviere O, Pecanka J, Mason MD, Schoots IG, van Der Kwast TH, van Der Poel HG, Wiegel T, Willemse PM, Yuan Y, Lam TB, Cornford P, Mottet N. Prognostic Value of Biochemical Recurrence Following Treatment with Curative Intent for Prostate Cancer: A Systematic Review. Eur Urol. 2019 Jun;75(6):967-987. doi: 10.1016/j.eururo.2018.10.011. Epub 2018 Oct 17. — View Citation

Yokomizo A, Wakabayashi M, Satoh T, Hashine K, Inoue T, Fujimoto K, Egawa S, Habuchi T, Kawashima K, Ishizuka O, Shinohara N, Sugimoto M, Yoshino Y, Nihei K, Fukuda H, Tobisu KI, Kakehi Y, Naito S; JCOG0401 Investigators. Salvage Radiotherapy Versus Hormone Therapy for Prostate-specific Antigen Failure After Radical Prostatectomy: A Randomised, Multicentre, Open-label, Phase 3 Trial (JCOG0401)dagger. Eur Urol. 2020 Jun;77(6):689-698. doi: 10.1016/j.eururo.2019.11.023. Epub 2019 Dec 19. — View Citation

Zapatero A, Guerrero A, Maldonado X, Alvarez A, San-Segundo CG, Rodriguez MAC, Sole JM, Olive AP, Casas F, Boladeras A, de Vidales CM, de la Torre MLV, Vara S, Sanz JL, Calvo FA. High-dose radiotherapy and risk-adapted androgen deprivation in localised prostate cancer (DART 01/05): 10-year results of a phase 3 randomised, controlled trial. Lancet Oncol. 2022 May;23(5):671-681. doi: 10.1016/S1470-2045(22)00190-5. Epub 2022 Apr 12. — View Citation

* Note: There are 24 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary To compare 5-year MFS rates in prostate cancer patients treated with long- versus short-term ADT in combination with salvage radiotherapy Distant metastasis-free survival: time from administration of the first LHRH analogue (this same starting point applies to all secondary objectives) until the patient develops M1a disease (involved retroperitoneal lymph nodes) or M1b-c disease (bone/visceral involvement) according to RECIST 1.1 criteria based on conventional computed tomography (CT) imaging and bone scans. The use of advanced molecular imaging-PSMA or choline positron-emission tomography (PET)/CT-is subject to the centre-specific protocols in place at the participating hospitals; however, metastatic progression will be determined according to RECIST 1.1 criteria based on conventional imaging tests. 5 years
Secondary To compare the two study arms in terms of the Biochemical-relapse free interval BRFS: time to biochemical progression defined as an increase in PSA confirmed by a second PSA determination (0.2 ng/mL above the salvage radiotherapy nadir or a sustained elevation in PSA levels). 5 years
Secondary To compare the two study arms in terms of the Pelvic progression-free survival Pelvic PFS: time to local recurrence (prostate bed) and/or N1 disease (positive lymph nodes below the aortic bifurcation) according to RECIST 1.1 criteria by conventional CT imaging and bone scan. The use of advanced molecular imaging (PSMA or choline PET/CT) will depend on centre-specific protocols; determination of metastatic progression will be based on RECIST 1.1 criteria from conventional imaging tests. 5 years
Secondary To compare the two study arms in terms of the Time to start of cytotoxic treatment Cytotoxic treatment-free interval: time to the start of the first cytotoxic treatment or local treatment for oligorecurrence. 5 years
Secondary To compare the two study arms in terms of the Time to castration resistance Time interval to castration resistance: the time to biochemical and/or clinical progression with castration levels (testosterone < 50 ng/dL). Progression to castration resistance is defined as three consecutive increases in PSA (one-week intervals) with at least two PSA increases > 2 ng/mL and a 50% increase over the PSA nadir, progression of bone lesions (= two lesions on the bone scan), progression of soft tissue lesions (RECIST 1.1 criteria), or the development of = one soft tissue or visceral metastases (including lymph nodes). 5 years
Secondary To compare the two study arms in terms of the Cancer-specific survival time to death due to prostate cancer or treatment-related complications 5 years
Secondary To compare the two study arms in terms of the Overall survival time to death from any cause 5 years
Secondary To compare the two study arms in terms of the Acute and late toxicity Acute toxicity: toxicity (CTCAE criteria, v. 4.0; https://evs.nci.nih.gov) appearing any time from treatment initiation up to three months after completion of RT. 5 years
Secondary To compare the two study arms in terms of the Late toxicity -Late toxicity: from 3 months to 5 years after completing RT (CTCAE v 4.0). 5 years
Secondary To compare the two study arms in terms of Quality of life (QoL) Quality of life (QoL): from baseline (prior to RT) to five years after completion of RT, assessed with the EORTC QLQ-C30 and QLQ-PR25 questionnaires. 5 years
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