Clinical trial of androgen deprivation therapy combined with salvage radiotherapy when treating prostate cancer that has suffered recurrence after surgery

Phase 3

Recruiting

• Conditions: Prostate Cancer

• Registration Number: 2024-517666-41-00
• Lead Sponsor: Instituto De Investigacion En Oncología Radioterapica FEOR

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-11-08
• Last Update Posted: 2025-05-07

Recruitment & Eligibility

• Status: Ongoing, recruiting
• Sex: Male
• Target Recruitment: 534

Inclusion Criteria

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 Criteria

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).

Previous pelvic radiotherapy

Radiotherapy contraindicated

Ongoing treatment with ADT or PSA-modulating drugs (e.g., finasteride, dutasteride, high dose steroids)

Inability to understand the treatment protocol or sign informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compared to short-term ADT (6 months), long-term ADT (24 months) could improve 5-year distant metastasis-free survival (MFS) in patients with biochemically-recurrent prostate cancer after radical prostatectomy who are candidates for salvage radiotherapy		Compared to short-term ADT (6 months), long-term ADT (24 months) could improve 5-year distant metastasis-free survival (MFS) in patients with biochemically-recurrent prostate cancer after radical prostatectomy who are candidates for salvage radiotherapy

Trial Locations

Locations (17)

Hospital Universitario De Cruces; 🇪🇸 Barakaldo, Spain

Hospital Universitario Fundacion Jimenez Diaz; 🇪🇸 Madrid, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Universitario 12 De Octubre; 🇪🇸 Madrid, Spain

Hospital Universitari Vall D Hebron; 🇪🇸 Barcelona, Spain

Hospital Universitario Quironsalud Madrid; 🇪🇸 Pozuelo De Alarcon, Spain

Hospital Universitario Y Politecnico La Fe; 🇪🇸 Valencia, Spain

Hospital Universitario Ramon Y Cajal; 🇪🇸 Madrid, Spain

Hospital Clinic De Barcelona; 🇪🇸 Barcelona, Spain

Institut Catala D'oncologia; 🇪🇸 L'hospitalet De Llobregat, Spain

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Hospital Universitario De Cruces

🇪🇸Barakaldo, Spain

Alfonso Gómez de Iturriaga

Site contact

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agomeziturriaga@gmail.com