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Taking people in SpainPhase 3

Compares treatment lengths for prostate cancer that returned after surgery

Tests how long hormone therapy should last with radiotherapy in men with returned prostate cancer.

Key facts

Who runs it
Instituto De Investigacion En Oncología Radioterapica FEOR
Where
Barakaldo, Barcelona, L'Hospitalet de Llobregat, Madrid, Málaga, Palma, Pozuelo de Alarcón, Reus, Valencia, and Vigo, SpainSee the 19 sites
Registry title
Clinical trial of androgen deprivation therapy combined with salvage radiotherapy when treating prostate cancer that has suffered recurrence after surgery
Status
Recruiting
Phase
Phase 3
People taking part
534 people, planned
Started
13 Mar 2023
Planned end
17 Mar 2026
Type of study
Interventional
Record updated
14 January 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for men whose prostate cancer came back (PSA rose) after surgery to remove the prostate. It compares longer and shorter hormone therapy given together with radiotherapy.

Age
18 to 64 years
Sex
Men only
Disease stage
Prostate cancer treated with radical prostatectomy, with a rising PSA after surgery (PSA 0.2 ng/mL or higher, confirmed by a second higher test at least two weeks later). For Gleason 8-10, pT3b or R1, PSA 0.15 ng/mL or higher. Intermediate or high risk. No visible cancer on scans.
Earlier treatment
Must have had radical prostatectomy. Cannot have had earlier pelvic radiotherapy or be taking hormone therapy (ADT) or PSA-lowering drugs now.
Biomarker or test result
Testosterone above 150 ng/dL at the start. PSA of 0.2 ng/mL or higher (0.15 ng/mL or higher for Gleason 8-10, pT3b or R1).

Main reasons for not taking part

  • Cancer in the lymph nodes (pN1) in the surgery sample
  • Cancer visible on scans
  • Earlier pelvic radiotherapy
  • Radiotherapy not possible
  • Current hormone therapy or PSA-lowering drugs

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

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 Spain

  • Hospital Universitario de CrucesBarakaldo, SpainTaking people
  • Hospital Clinic de BarcelonaBarcelona, SpainTaking people
  • Hospital de la Santa Creu i Sant PauBarcelona, SpainTaking people
  • Hospital Universitari Vall d'HebronBarcelona, SpainTaking people
  • Institut Catala D'oncologiaL'Hospitalet de Llobregat, SpainTaking people
  • Hospital General Universitario Gregorio MarañónMadrid, SpainTaking people
  • Hospital Ruber InternacionalMadrid, SpainTaking people
  • Hospital Universitario 12 de OctubreMadrid, SpainTaking people
  • Hospital Universitario Fundación Jiménez DíazMadrid, SpainTaking people
  • Hospital Universitario HM SanchinarroMadrid, SpainTaking people
  • Hospital Universitario La PazMadrid, SpainTaking people
  • Hospital Universitario Ramón y CajalMadrid, SpainTaking people
  • Hospital Universitario San Francisco de AsisMadrid, SpainTaking people
  • Hospital Universitario Virgen de la VictoriaMálaga, SpainTaking people
  • University Hospital Son EspasesPalma, SpainTaking people
  • Hospital Universitario Quironsalud MadridPozuelo de Alarcón, SpainTaking people
  • Salut Sant Joan de ReusReus, SpainTaking people
  • Hospital Universitario Y Politecnico La FeValencia, SpainTaking people
  • Complexo Hospitalario Universitario De VigoVigo, SpainTaking people

About the trial

What the trial wants to find out

To compare 5-year MFS rates in prostate cancer patients treated with long- versus short-term ADT in combination with salvage radiotherapy

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Compares treatment lengths for prostate cancer that returned after surgeryGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Fit questions
Built from 2024-517666-41-00, who can take part
Record updated
14 January 2026