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Short Versus Long-term Androgen Deprivation Therapy With Salvage Radiotherapy in Prostate Cancer. URONCOR 0624

RecruitingPhase 3Ages 18 Years - anyAllInstituto de Investigación en Oncología Radioterá…
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In plain words

What the trial is, and whether it could suit you

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-f

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📋 Eligibility rules (as published)
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
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What it tests

  • triptorelin, goserelin, leuprorelin
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Where

17 sites
Instituto Catalán de Oncología Hospitalet
L'Hospitalet de Llobregat, Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada, Spain
Hospital Universitario Quirón Madrid
Pozuelo de Alarcón, Spain
Hospital de Cruces
Barakaldo, Spain
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital San Francisco de Asís
Madrid, Spain

…and 9 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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