This is an open-label, phase II trial in patients with PSA recurrence after prostatectomy. Patients entering the study will all receive initial 50 Gray (Gy) radiotherapy (25 x 2Gy) to the prostate bed and thereafter be classified as either responders or non-responders depending on PSA response at fifth week of radiotherapy. A 68-Ga- PSMA-PET is done before start of radiotherapy, and analyzed before fifth treatment week in order to identify cancer lesions in patients with poor PSA response. Patients with PSA response after 5 weeks of radiotherapy will not receive any subsequent therapy, whilst patients with poor PSA response may be in need for additional therapy such as radiotherapy to lymph node metastases and/or boost fractions to local recurrence. Patients with more than 3 lymph node metastases or distant metastases will not receive any more radiotherapy, but individualized systemic therapy will be started.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Lund University Hospital
Lund, Sweden
Tumor detection rate measured with Ga-PSMA-PET in non-responders versus responders.
Time frame: PSA response is evaluated after 5 weeks of radiotherapy. Ga-PSMA-PET at baseline is compared in the PSA-responder group as compared to the non-responder group
Assessment of PSA response during radiotherapy.
Time frame: Is evaluated once weekly during radiotherapy, duration of radiotherapy is 35 days; 70 Gy in 2 Gy fractions.
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