prostate carcinoma, biochemical recurrence prostate cancer, PSA elevation after surgery
Conditions
Interventions
Control group: early SRT (PSA = 0.2 ng/ml) to the prostatic bed (standard of care) versus 
Study group: initial follow-up with 3-monthly PSA measurement for all patients in the first year, followed by 6-monthly PSA measurement the following two years. PSMA PET is repeated in those in whom t
Sponsors
St. Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age > 18 yearshistologically proven adenocarcinoma of the prostateInitial localized prostate cancer (T1-T3N0Mx/0) Previous radical prostatectomy (with or without pelvic lymph node dissection (PLND) and in case of PLND, pN0) Any risk group before prostatectomy Biochemical recurrence (defined as PSA = 0.2 ng/mL and rising) PSMA-PET/CT performed after identification of BCR, showing no signs of disease.Candidate for salvage radiotherapy of the prostatic fossa, as indicated by multidisciplinary meeting (EAU (European Association of Urology) low and high BCR risk groups may be included, as long as patients are deemed suitable for salvage EBRT based on the combination of patient- and tumor-related factors). However, high and low risk BCR groups should be equally divided over the standard vs intervention groups. Any PSMA tracer is allowed (68-Ga, F18, DCFPYL etc). Life expectancy of > 10 years Written informed consent
Exclusion criteria
Exclusion criteria: previous pelvic irradiationsecondary solid organ malignancy Evidence of lymph node involvement at pre-operative imaging or lymph node dissection (miN1/pN1) Evidence of local recurrence on imaging at the time of inclusion (BCR)Biochemical persistent disease after prostatectomy (detectable PSA >0.1)Previous hormonal therapy in the neo-adjuvant or adjuvant setting to prostatectomyPatients who are incompetent to sign written informed consent Evidence of a non-PSMA-avid primary tumor, defined as absence of PSMA-avid lesions on pre-operative or peri-operative PSMA PET/CT in the presence of histologically confirmed prostate cancer, precluding reliable PSMA-based disease monitoring during follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with lymph node and/or distant metastasis on imaging. Active follow-up: three years. Patients in the study group (initial expectant management) undergo repeat PSMA if the PSA rises to = 0.8 ng/ml [= PSA at moment of first PSMA {0.2 ng/ml} + 0.6]. In the Standard Of Care arm, during follow-up after salvage radiotherapie patients undergo repeat imaging, conform guidelines if the PSA reaches the thresholds of PSAnadir + 0.6 ng/ml. | — |
Secondary
| Measure | Time frame |
|---|---|
| Acute and late grade 1-5 toxicity (GU, GI, and erectile dysfunction [ED]) according to CTCAE version 5 up to 3 years follow-up.Distribution of low versus high volume metastatic disease in recurrent setting.Patient-reported Quality of Life (questionnaires) up to 3-years follow-up, EORTC-QLQ-C30.Chance of PSA progression of = 0.8 ng/mL in the interventional arm.ADT-free, overall and prostate-cancer specific survival up to 3-years, and if signed consent by the patient up to 15 years, follow-up.Patterns of failure analyses in case of biochemical failure.Evaluation of predictive factors for biochemical failure, tumour progression, and if possible, toxicity. | — |
Countries
Netherlands
Contacts
Public ContactV. Sweere
St. Antonius Ziekenhuis
Outcome results
None listed