Clinical trial · Interventional
Pelvic Nodes Ultra-Hypo vs Conventionally Fractionated IMRT With HDR Boost in Prostate Cancer.
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)
NCT05820633CI-TRIAL-00095001PCS-XIsuspendedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): amendment to be done, adding 200 patients
Summary
Brief summary (as posted)
Randomized Phase III study, comparing pelvic ultra-hypo fractionated radiotherapy (UHF: 5Gy/fraction) to a standard or moderate hypo-fractionation (1.8-2.15Gy/fraction), both associated to an HDR prostate +/- adjacent seminal vesicles brachytherapy boost (HDR-BT)+ ADT according to NCCN guidelines. Considering that the calculated bio-equivalent doses to the tumor are similar for all treatment options, the UHF technique is deemed to be non-inferior to the standard approach. Treatment acceptability, tolerance and adverse events will be reported and compared for non-inferiority as the primary objective. Secondary objectives are biochemical control, metastasis-free, disease specific and overall survival.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Node; Prostate | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Radiotherapy Side Effect | — | UNRESOLVED | — |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Report and compare changes in a non-inferiority analysis of the expanded prostate cancer index composite" (EPIC-26): | Radiation | — | UNRESOLVED |
| Report and compare changes in a non-inferiority analysis of the International Prostate Symptom Score (I-PSS) | Radiation | — | UNRESOLVED |
| Report and compare changes in a non-inferiority analysis of the Sexual Health Inventory for Men (SHIM) | Radiation | — | UNRESOLVED |
| Report and compare changes in a non-inferiority analysis of the toxicities reported according to the Common Terminology Criteria for Adverse Events (CTCAE) | Radiation | — | UNRESOLVED |
| Report and compare the biochemical disease free survival (bDFS) | Radiation | — | UNRESOLVED |
| Report and compare the disease free survival (DFS) | Radiation |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ultra hypo fractionation radiation therapy (UHF)
- description
- 5 radiation treatments (5 Gy per fraction) to the prostate, seminal vesicle and pelvic nodes given every other day over 2 weeks for a total of 25 Gy.
- interventionNames
- Radiation: Report and compare changes in a non-inferiority analysis of the International Prostate Symptom Score (I-PSS)
- Radiation: Report and compare changes in a non-inferiority analysis of the expanded prostate cancer index composite" (EPIC-26):
- Radiation: Report and compare changes in a non-inferiority analysis of the Sexual Health Inventory for Men (SHIM)
- Radiation: Report and compare changes in a non-inferiority analysis of the toxicities reported according to the Common Terminology Criteria for Adverse Events (CTCAE)
- Radiation: Report and compare the biochemical disease free survival (bDFS)
- Radiation: Report and compare the disease free survival (DFS)
- Radiation: Report and compare the metastase free survival (MFS)
- Radiation: Report and compare the overall survival (OS)
- type
- ACTIVE_COMPARATOR
- label
- standard of care fractionation (SOC)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 95 Years
Show eligibility criteria text
Inclusion Criteria: * Histopathologically confirmed adenocarcinoma of the prostate. * All clinical stages with lymph node involvement risk needing pelvis RT. * Stage Mx or M0. * Unfavorable Intermediate, high or very high-risk disease according to NCCN guidelines. * Having the ability to give free and informed consent. Exclusion Criteria: * Clinical stage M1. * IPSS Score \> 20 with alpha-blocking medication. * Prior pelvic radiotherapy, * History of active collagenosis (Lupus, Scleroderma, Dermatomyositis). * Past history of Inflammatory Bowell Disease. * Bilateral hip prosthesis.
References
Publications (15)
- BACKGROUNDHuynh-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. PMID 31899813
- BACKGROUNDHeidenreich 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. PMID 11912387
- BACKGROUNDGreenberger 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. PMID 31813810
- BACKGROUNDYin 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. PMID 31697452
- BACKGROUNDTharmalingam 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. PMID 31610249
- BACKGROUNDMorton 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.