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
- Conditions
- Short versus long-term androgen deprivation therapy combined with salvage radiotherapy in prostate cancer patients with biochemical recurrence after prostatectomyTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2021-006975-41-ES
- Lead Sponsor
- GICOR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- 534
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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:<br>- Biochemical-relapse free interval<br>- Pelvic progression-free survival <br>- Time to start of cytotoxic treatment<br>- Time to castration resistance<br>-Cancer-specific survival<br>- Overall survival<br>- 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 Outcome Measures
Name Time Method 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:<br>- Biochemical-relapse free interval<br>- Pelvic progression-free survival <br>- Time to start of cytotoxic treatment<br>- Time to castration resistance<br>-Cancer-specific survival<br>- Overall survival<br>- Acute and late toxicity