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Table 1 Summary of study visits and procedures

From: PEACE V – Salvage Treatment of OligoRecurrent nodal prostate cancer Metastases (STORM): a study protocol for a randomized controlled phase II trial

TIMEPOINT   STUDY PERIOD
ScreeningAllocationTreatment periodFollow-up period
Within 8 weeks prior to randomizationWithin 2 weeks prior to randomizationBaselineStartDuringEnd1 month after treatment
± 7 days
3 months after treatment
± 14 days
6 months after treatment
± 14 days
6-monthly, yearly, until progression (g)
± 14 days
Window
ENROLMENT: 
Eligibility screenx         
Signed ICFx         
Randomization  x       
INTERVENTIONS (a,b): 
If sLND   xxx    
If WPRT   xxx    
If SBRT   xxx    
ADT   xxxxxx 
ASSESSMENTS: 
Medical historyx         
Patients characteristics x        
Physical exam (c) x   xxxxx
Lab
 PSA x   x (h)xxxx
 Testosterone x    xxxx
 Biomarker x       x (i)
Imaging
 PET-CT (d)x      (x)(x)(x)
 MRI (e)x         
Adverse Events
 Baseline toxicity x        
 Acute toxicity (f)   (x)(x)xxx  
 Late toxicity        xx
Medication
 Prior medication x        
 Con med’s     xxxxx
Quality of life
 QLQ-C30 x     xxx
 QLQ-PR25 x     xxx
Survival status      xxxx
  1. (a) All arms should receive an LHRH-agonist or antagonist for a duration of 6 months using 1 monthly formulations. In case of SBRT/WPRT, ADT should start no later than the first fraction (whichever RT treatment comes first) and no earlier than 2 weeks before the start of radiotherapy. In case of sLND, ADT should be started no earlier than 1 day postoperatively and no later than 10 days postoperatively
  2. (b) Treatment should start preferably within 4 weeks after randomization, but no later than 8 weeks after randomization. Treatment period is defined as the time between first treatment day and last treatment of surgery and/or radiotherapy
  3. (c) Physical examination including scoring of Performance Status. Weight and height will only be measured at screening
  4. (d) Whole body choline, PSMA or FACBC PET-CT/−MRI. During follow-up repeat PET-CT only at time of biochemical relapse and then 6-monthly afterwards until clinical progression is determined or earlier in case of symptomatic progression
  5. (e) Optional: for patients without a prior radical prostatectomy it is recommended to perform a multiparametric MRI of the prostate to rule out local recurrence
  6. (f) During the treatment period a toxicity assessment should be done at least once a week in case of WPRT. For SBRT toxicity assessment should be done only at end of treatment, for sLND at discharge (Clavien-Dindo scale)
  7. (g) 6-monthly follow-up for a minimum of 24 months, with yearly follow-up thereafter up to 60 months or until progression. In case of clinical progression, the patient will be treated according to the EAU guidelines
  8. (h) In case of SBRT/WPRT, PSA has to be determined on the day of the last fraction. In case of sLND in arm A, PSA will be determined at 4 weeks after surgery (follow-up month 1). In case of sLND + WPRT in arm B, PSA will be determined at 4 weeks post-WPRT (follow-up month 1)
  9. (i) At time of primary endpoint is reached, a new biomarker sampling is preferred, but optional