Less than 50% of patients receiving salvage radiation therapy (SRT) to the pelvis as treatment for prostate cancer relapsing after surgery will achieve undetectable Prostate Specific Antigen (PSA) levels. Despite SRT, two-thirds of patients will again develop elevated PSA, 20% will have distant metastases, and 10% will die from prostate cancer within 10 years. The reason for this is probably preexisting distant metastasis and lymph node metastasises which need to better targeted directly. Additionally , there are well known permanent side effects to SRT. Standard imaging techniques have poor sensitivity detecting recurrence when PSA is below 1.0 ng/ml. The surface protein Prostate-specific membrane antigen (PSMA) is overexpressed on prostate cancer cells and 68Gallium (68Ga)- and 18Fluorine (18F)-targeted radioligands have been developed. PSMA PET/CT is used increasingly but there is limited data of its impact. In this study patients with biochemical relapse of prostate cancer after surgery are randomised to the control or experimental group (1:2) and undergo a PSMA PET/CT scan. The experimental group receives individualised therapy based on the result of the PET/CT. The control group receives standard salvage therapy and the result of the PET/CT is blinded. The patients are followed-up with PSA test and quality of life questionnaires.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
450
Group I - No uptake: treated with conventional SRT against the prostate bed. Group II -Uptake only in the prostate bed: will receive intensity modulated RT (IMRT) including Volumetric Modulated Arc Therapy (VMAT) for prostate bed with simultaneous-integrated boost (SIB) to the PET positive uptake in the prostate bed. Group III - Uptake in the prostate bed and involvement of regional lymph nodes in the pelvis: will be treated as Group II plus VMAT for the pelvic lymph nodes with SIB to the PET positive lymph nodes or pelvic lymph nodes salvage lymph node dissection (SLND). Group IV - Uptake in regional lymph nodes only: will be treated with VMAT for the pelvic lymph nodes with SIB to the PET positive lymph nodes or pelvic lymph nodes SLND. Group V - Uptake in extra-pelvic lymph nodes or bone metastasis: systemic treatment instead of surgery or radiation. Local treatment with surgery or radiation is acceptable if curative intention.
Standard salvage radiotherapy
Sahlgrenska University Hospital
Gothenburg, Göteborg, Sweden
RECRUITINGSödersjukhuset
Stockholm, Stockholm County, Sweden
NOT_YET_RECRUITINGKarolinska University Hospital
Stockholm, Stockholm County, Sweden
RECRUITINGNorrland's University Hospital
Umeå, Sweden
NOT_YET_RECRUITINGÖrebro University Hospital
Örebro, Örebro County, Sweden
NOT_YET_RECRUITINGPrimary PSA progression free survival
Number of patients with progress defined by Prostate-Specific Antigen (PSA) measurement
Time frame: Throughout the study, approximately 10 years.
Time to metastasis
Time to documented metastasis of prostate cancer
Time frame: At 5, 7 and 10 years
Prostate cancer specific survival
Time to prostate cancer specific death
Time frame: At 5, 7 and 10 years
Time to secondary treatment
Time to need for secondary treatment for prostate cancer
Time frame: At 5, 7 and 10 years
Differences in quality of life recorded using Patient Reported Outcome Measure (PROM)
A modified version of the PSMA questionnaire developed by the National Prostate Cancer Register. Scale from 1 to 5 were 1 is very good and 5 is very bad.
Time frame: Baseline, 6, 12, 36 and 60 months after completed treatment.
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