Clinical trial · no report yet · Phase not applicable
PCS-XI
Pelvic Nodes Ultra-Hypo vs Conventionally Fractionated IMRT With HDR Boost in Prostate Cancer.
- NCT05820633 ↗
- Suspended
- CHU de Quebec-Universite Laval
- Standard
We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Preliminary discovery
Commentary in our index that names this trial so far
Podcasts, YouTube videos and X posts we have indexed. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build.
| Channel | Found | |
|---|---|---|
| X threads | 14 | |
| Bluesky threads | 1 |
The trial
ClinicalTrials.gov- Official title
- Pelvic Nodes Ultra-Hypo Fractionated Versus Conventionally Fractionated IMRT With HDR Brachytherapy Boost in Prostate Cancer: A Collaborative Multi-institutional Non-inferiority Phase 3 Trial. (PCS-XI)
- Phase
- Phase not applicable
- Status
- Suspended
- Conditions
- Prostate Cancer; Node; Prostate; Radiotherapy Side Effect
- Interventions
- Report and compare changes in a non-inferiority analysis of the International Prostate Symptom Score (I-PSS); Report and compare changes in a non-inferiority analysis of the expanded prostate cancer index composite" (EPIC-26):; Report and compare changes in a non-inferiority analysis of the Sexual Health Inventory for Men (SHIM); Report and compare changes in a non-inferiority analysis of the toxicities reported according to the Common Terminology Criteria for Adverse Events (CTCAE); Report and compare the biochemical disease free survival (bDFS); Report and compare the disease free survival (DFS); Report and compare the metastase free survival (MFS); Report and compare the overall survival (OS)
- Arms
- ultra hypo fractionation radiation therapy (UHF) · Experimental
- standard of care fractionation (SOC) · Active comparator
- Enrollment
- 500 (estimated)
- Primary outcomes
- Non-inferiority analysis of early change in genito-urinary (GU) toxicities induced.
- Non-inferiority analysis of early change in reported Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire.
- Non-inferiority analysis of late change in genito-urinary (GU) toxicities induced.
- Non-inferiority analysis of late change in reported Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire.
- Non-inferiority analysis of early change in sexual health.
- Non-inferiority analysis of late change in sexual health.
- Non-inferiority analysis of early change in toxicities reporte via the Common Terminology Criteria for Adverse Events (CTCAE).
- Non-inferiority analysis of late change in toxicities reporte via the Common Terminology Criteria for Adverse Events (CTCAE).
- Sponsor
- CHU de Quebec-Universite Laval with TerSera Therapeutics LLC
- Start
- Sep 1, 2022
- Primary completion
- Nov 2026 (estimated)
- Results posted
- No
- Registry record
- NCT05820633 · updated Sep 12, 2025
Publications
linked from the registry- Huynh-Le MP, Myklebust TA, Feng CH, Karunamuni R, Johannesen TB, Dale AM, Andreassen OA, Seibert TM. Age dependence of modern clinical risk groups for localized prostate cancer-A population-based study. Cancer. 2020 Apr 15;126(8):1691-1699. doi: 10.1002/cncr.32702. Epub 2020 Jan 3. PubMed 31899813
- Heidenreich A, Varga Z, Von Knobloch R. Extended pelvic lymphadenectomy in patients undergoing radical prostatectomy: high incidence of lymph node metastasis. J Urol. 2002 Apr;167(4):1681-6. PubMed 11912387
- Greenberger BA, Zaorsky NG, Den RB. Comparison of Radical Prostatectomy Versus Radiation and Androgen Deprivation Therapy Strategies as Primary Treatment for High-risk Localized Prostate Cancer: A Systematic Review and Meta-analysis. Eur Urol Focus. 2020 Mar 15;6(2):404-418. doi: 10.1016/j.euf.2019.11.007. Epub 2019 Dec 5. PubMed 31813810
- Yin M, Zhao J, Monk P, Martin D, Folefac E, Joshi M, Jin N, Mortazavi A, Verschraegen C, Clinton S. Comparative effectiveness of surgery versus external beam radiation with/without brachytherapy in high-risk localized prostate cancer. Cancer Med. 2020 Jan;9(1):27-34. doi: 10.1002/cam4.2605. Epub 2019 Nov 7. PubMed 31697452
- Tharmalingam H, Tsang Y, Choudhury A, Alonzi R, Wylie J, Ahmed I, Henry A, Heath C, Hoskin PJ. External Beam Radiation Therapy (EBRT) and High-Dose-Rate (HDR) Brachytherapy for Intermediate and High-Risk Prostate Cancer: The Impact of EBRT Volume. Int J Radiat Oncol Biol Phys. 2020 Mar 1;106(3):525-533. doi: 10.1016/j.ijrobp.2019.09.044. Epub 2019 Oct 11. PubMed 31610249
- Morton G, Loblaw A, Cheung P, Szumacher E, Chahal M, Danjoux C, Chung HT, Deabreu A, Mamedov A, Zhang L, Sankreacha R, Vigneault E, Springer C. Is single fraction 15 Gy the preferred high dose-rate brachytherapy boost dose for prostate cancer? Radiother Oncol. 2011 Sep;100(3):463-7. doi: 10.1016/j.radonc.2011.08.022. Epub 2011 Sep 14. PubMed 21924511
- Hill RP, Rodemann HP, Hendry JH, Roberts SA, Anscher MS. Normal tissue radiobiology: from the laboratory to the clinic. Int J Radiat Oncol Biol Phys. 2001 Feb 1;49(2):353-65. doi: 10.1016/s0360-3016(00)01484-x. PubMed 11173128
- Williams MV, Denekamp J, Fowler JF. A review of alpha/beta ratios for experimental tumors: implications for clinical studies of altered fractionation. Int J Radiat Oncol Biol Phys. 1985 Jan;11(1):87-96. doi: 10.1016/0360-3016(85)90366-9. PubMed 3881377
- McCammon R, Rusthoven KE, Kavanagh B, Newell S, Newman F, Raben D. Toxicity assessment of pelvic intensity-modulated radiotherapy with hypofractionated simultaneous integrated boost to prostate for intermediate- and high-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2009 Oct 1;75(2):413-20. doi: 10.1016/j.ijrobp.2008.10.050. Epub 2009 Apr 11. PubMed 19362783
- Widmark A, Gunnlaugsson A, Beckman L, Thellenberg-Karlsson C, Hoyer M, Lagerlund M, Kindblom J, Ginman C, Johansson B, Bjornlinger K, Seke M, Agrup M, Fransson P, Tavelin B, Norman D, Zackrisson B, Anderson H, Kjellen E, Franzen L, Nilsson P. Ultra-hypofractionated versus conventionally fractionated radiotherapy for prostate cancer: 5-year outcomes of the HYPO-RT-PC randomised, non-inferiority, phase 3 trial. Lancet. 2019 Aug 3;394(10196):385-395. doi: 10.1016/S0140-6736(19)31131-6. Epub 2019 Jun 18. PubMed 31227373
- 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 Sep 1;78(1):11-8. doi: 10.1016/j.ijrobp.2009.07.1691. Epub 2010 Jan 4. PubMed 20047800
- D'Amico AV, Chen MH, Renshaw AA, Loffredo M, Kantoff PW. Androgen suppression and radiation vs radiation alone for prostate cancer: a randomized trial. JAMA. 2008 Jan 23;299(3):289-95. doi: 10.1001/jama.299.3.289. PubMed 18212313
- Partin AW, Mangold LA, Lamm DM, Walsh PC, Epstein JI, Pearson JD. Contemporary update of prostate cancer staging nomograms (Partin Tables) for the new millennium. Urology. 2001 Dec;58(6):843-8. doi: 10.1016/s0090-4295(01)01441-8. PubMed 11744442
- Hall WA, Paulson E, Davis BJ, Spratt DE, Morgan TM, Dearnaley D, Tree AC, Efstathiou JA, Harisinghani M, Jani AB, Buyyounouski MK, Pisansky TM, Tran PT, Karnes RJ, Chen RC, Cury FL, Michalski JM, Rosenthal SA, Koontz BF, Wong AC, Nguyen PL, Hope TA, Feng F, Sandler HM, Lawton CAF. NRG Oncology Updated International Consensus Atlas on Pelvic Lymph Node Volumes for Intact and Postoperative Prostate Cancer. Int J Radiat Oncol Biol Phys. 2021 Jan 1;109(1):174-185. doi: 10.1016/j.ijrobp.2020.08.034. Epub 2020 Aug 27. PubMed 32861817
- Gregoire JP, Moisan J, Labrecque M, Cusan L, Diamond P. [Validation of a French adaptation of the international prostatic symptom score]. Prog Urol. 1996 Apr;6(2):240-9. French. PubMed 8777417