Condition: Prostate Cancer · Salvage Radiotherapy · Biochemical Recurrence · Sponsor: Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic
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 w…
This description comes directly from the study's public registry record.
Pablo Raña, PhD · 0034696633409 · investigacion@seor.es
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| Instituto Catalán de Oncología Hospitalet | L'Hospitalet de Llobregat, Barcelona, Spain | Not Yet Recruiting |
| Hospital Universitario de Fuenlabrada | Fuenlabrada, Madrid, Spain | Active Not Recruiting |
| Hospital Universitario Quirón Madrid | Pozuelo de Alarcón, Madrid, Spain | Recruiting |
| Hospital de Cruces | Barakaldo, Vizcaya, Spain | Not Yet Recruiting |
| Hospital Universitario Vall d'Hebron | Barcelona, Spain | Not Yet Recruiting |
| Hospital Clinic de Barcelona | Barcelona, Spain | Not Yet Recruiting |
| Hospital de la Santa Creu i Sant Pau | Barcelona, Spain | Not Yet Recruiting |
| Hospital San Francisco de Asís | Madrid, Spain | Recruiting |
| Hospital Gregorio Marañón | Madrid, Spain | Recruiting |
| Hospital Ramón y Cajal | Madrid, Spain | Recruiting |
| Hospital Ruber Internacional | Madrid, Spain | Recruiting |
| Hospital Clínico San Carlos | Madrid, Spain | Not Yet Recruiting |
+ 5 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05781217