Short versus long-term androgen deprivation therapy combined with salvage radiotherapy in prostate cancer patients with biochemical recurrence after prostatectomy
Conditions
Interventions
Trade Name: Decapeptyl semestral
Product Name: triptorelina equivalente
Pharmaceutical Form: Powder and solvent for prolonged-release suspension for injection
INN or Proposed INN: TRIPTORELIN
CAS Numb
Sponsors
GICOR
Eligibility
Sex/Gender
Male
Inclusion criteria
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) (Protocol page 8) 4. Testosterone level > 150 ng/dL at inclusion 5. ECOG 0-1 6. Life expectancy > 5 years 7. Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 534 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare 5-year MFS rates in prostate cancer patients treated with long- versus short-term ADT in combination with salvage radiotherapy.;Secondary Objective: To compare the two study arms in terms of the following variables: - Biochemical-relapse free interval - Pelvic progression-free survival - Time to start of cytotoxic treatment - Time to castration resistance -Cancer-specific survival - Overall survival - Acute and late toxicity;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 5 years;Secondary end point(s): To compare the two study arms in terms of the following variables: - Biochemical-relapse free interval - Pelvic progression-free survival - Time to start of cytotoxic treatment - Time to castration resistance -Cancer-specific survival - Overall survival - Acute and late toxicity | — |
Countries
Spain
Contacts
Public ContactLOLA DE AREBA
GICOR
Outcome results
None listed