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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

Screening

Allocation

Treatment period

Follow-up period

Within 8 weeks prior to randomization

Within 2 weeks prior to randomization

Baseline

Start

During

End

1 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 screen

x

         

Signed ICF

x

         

Randomization

  

x

       

INTERVENTIONS (a,b):

 

If sLND

   

x

x

x

    

If WPRT

   

x

x

x

    

If SBRT

   

x

x

x

    

ADT

   

x

x

x

x

x

x

 

ASSESSMENTS:

 

Medical history

x

         

Patients characteristics

 

x

        

Physical exam (c)

 

x

   

x

x

x

x

x

Lab

 PSA

 

x

   

x (h)

x

x

x

x

 Testosterone

 

x

    

x

x

x

x

 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)

x

x

x

  

 Late toxicity

        

x

x

Medication

 Prior medication

 

x

        

 Con med’s

     

x

x

x

x

x

Quality of life

 QLQ-C30

 

x

     

x

x

x

 QLQ-PR25

 

x

     

x

x

x

Survival status

      

x

x

x

x

  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
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BMC Cancer

ISSN: 1471-2407

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