Clinical trial of androgen deprivation therapy combined with salvage radiotherapy when treating prostate cancer that has suffered recurrence after surgery
Key facts
- Where
- Barakaldo, Barcelona, L'Hospitalet de Llobregat, Madrid, Málaga, Palma, Pozuelo de Alarcón, Reus, Valencia és Vigo, SpanyolországSee the 19 sites
- Phase
- 3. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Spanyolország
- Hospital Universitario de CrucesBarakaldo, SpanyolországTaking people
- Hospital Clinic de BarcelonaBarcelona, SpanyolországTaking people
- Hospital de la Santa Creu i Sant PauBarcelona, SpanyolországTaking people
- Hospital Universitari Vall d'HebronBarcelona, SpanyolországTaking people
- Institut Catala D'oncologiaL'Hospitalet de Llobregat, SpanyolországTaking people
- Hospital General Universitario Gregorio MarañónMadrid, SpanyolországTaking people
- Hospital Ruber InternacionalMadrid, SpanyolországTaking people
- Hospital Universitario 12 de OctubreMadrid, SpanyolországTaking people
- Hospital Universitario Fundación Jiménez DíazMadrid, SpanyolországTaking people
- Hospital Universitario HM SanchinarroMadrid, SpanyolországTaking people
- Hospital Universitario La PazMadrid, SpanyolországTaking people
- Hospital Universitario Ramón y CajalMadrid, SpanyolországTaking people
- Hospital Universitario San Francisco de AsisMadrid, SpanyolországTaking people
- Hospital Universitario Virgen de la VictoriaMálaga, SpanyolországTaking people
- University Hospital Son EspasesPalma, SpanyolországTaking people
- Hospital Universitario Quironsalud MadridPozuelo de Alarcón, SpanyolországTaking people
- Salut Sant Joan de ReusReus, SpanyolországTaking people
- Hospital Universitario Y Politecnico La FeValencia, SpanyolországTaking people
- Complexo Hospitalario Universitario De VigoVigo, SpanyolországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Instituto De Investigacion En Oncología Radioterapica FEOR
- Trial code
- EU 2024-517666-41-00
- Record updated
- 2026. január 14.
- Original description
To compare 5-year MFS rates in prostate cancer patients treated with long- versus short-term ADT in combination with salvage radiotherapyRead full original descriptionShow less
Short versus long-term androgen deprivation therapy combined with salvage radiotherapy in prostate cancer patients with biochemical recurrence after prostatectomy: a multicentre phase III randomised controlled trial
To compare 5-year MFS rates in prostate cancer patients treated with long- versus short-term ADT in combination with salvage radiotherapy
Inclusion: Patients with histologically-confirmed prostate cancer treated with radical prostatectomy. Patients who have not undergone lymph node dissection are eligible for inclusion; 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; Intermediate and high-risk patients according to the classification criteria proposed by González San Segundo et al. (18) (Protocol page 8); Testosterone level > 150 ng/dL at inclusion; ECOG 0-1; Life expectancy > 5 years; Signed informed consent.
Exclusion: Previous pelvic radiotherapy; Radiotherapy contraindicated; Ongoing treatment with ADT or PSA-modulating drugs (e.g., finasteride, dutasteride, high dose steroids); Presence of pN1 disease in the original surgical specimen; 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; PSA <0.2 or <0.15 ng/mL (if Gleason score=10, pT3b, or R1 in the radical prostatectomy specimen); Inability to understand the treatment protocol or sign informed consent.