Cancer types
  • Urology
Title of study
PSMA-PET guided hypofractionated salvage prostate bed radiotherapy of biochemical failure after radical prostatectomy for prostate cancerClinical study for the Investigation of the ProSpace
Version Number
Approval Date 
4.0, 22 February 2021
Short Title
Study site
Principle Investigator
Dr. S. Aluwini, UMC Groningen
Investigator Maastro
Dr. B. Vanneste
Department of Radiotherapy. UMCG, Groningen
Trial registry

The main goal of this project is to investigate whether the oncologic outcome in patients with post-prostatectomy recurrent PCa can be improved, by increasing the biological effective radiation dose from 35 x 2 = 70 Gy to a hypofractionated schedule of 20 x 3 = 60 Gy.

Primary Endpoint 

The primary endpoint is 5-year PFS defined as biochemical progression, clinical progression, loco-regional or distant progression or start with hormonal therapy.

Secondary Endpoints 

• Acute grade ≥ 2 GI and GU toxicities measured at the end of the radiation course and up to 3 months after completion of the RT using both physician-reported score (CTCAE_5 criteria) and patient-reported questionnaires (according to the modified RTOG/EORTC criteria).
• 3- and 5-year late grade ≥ 2 GI and GU toxicities, reported using both physicianreported score (CTCAE_5 criteria) and patient-reported questionnaires (according to RTOG/EORTC). Late toxicity will be registered >3 months after completion of RT.
• Quality of Life (QoL), evaluated using the EORTC QLQ-C30 for health-related QoL and the EORTC PR-25 for prostate symptom-specific QoL.
• Metastasis-free survival.
• PCa-specific mortality.
• Overall survival at 5 years.