Salvage Stereotactic Body Radiotherapy of the Prostate Bed for Biochemical Recurrence After Radical Prostatectomy.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Stereotactic body radiotherapy (SBRT), SOC RT.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This is a a randomized phase II/III trial comparing salvage SBRT with standard of care (SOC) regimens for patients with a persistent detectable PSA or biochemical progression during follow-up after radical prostatectomy.
Detailed description
This is a multicentric randomized seamless phase II/III study comparing SBRT to conventional RT or moderately hypofractionated RT on the prostate bed.
All subjects will be randomly assigned in a 1:1 ratio:
1. Experimental arm: Radiotherapy treatment in 5 fractions. 2. Control arm: Radiotherapy treatment within a normofractionated or mildly hypofractionated schedule. For the control arm, each participating center can choose between a normofractionated schedule (32 to 35 treatment sessions) and a moderately hypofractionated schedule (20 sessions).
Interventions
- Radiation Stereotactic body radiotherapy (SBRT)
5 fractions of SBRT to the prostate bed with or without whole pelvic radiotherapy Treatment every other day. - Radiation SOC RT
Standard salvage radiotherapy to the prostate bed with or without whole pelvic radiotherapy. Each participating centre can specify upfront which RT schedule will be used in the control arm, with the choice between the following schedules: * Hypofractionated: 20 fractions (Daily treatment (OTT 4-5 weeks)) * Normofractionated: 32-35 fractions (Daily treatment (OTT 7-8 weeks))
Primary outcome measures
- SBRT impact on patient-reported GI and GU symptoms [Time frame: 2 years post treatment]
Secondary outcome measures (8)
- Patient Reported Outcomes [Time frame: at end of RT and following time-points counted from start of RT : 4-7 weeks (only in experimental arm), 3 months, 6 months, 1 year and yearly up to 5 years]
- Ccost-utility during radiotherapy [Time frame: during radiotherapy]
- Physician-scored toxicity [Time frame: up to 5 years]
- Blood lymphocyte evolution between study arms [Time frame: 5 years]
- To compare biochemical progression-free survival (bPFS) to historical control and between study arms [Time frame: 5 years]
- To compare local and regional recurrences between study arms, up to 5 years. [Time frame: 5 years]
- To compare Overall survival (OS) between study arms, up to 5 years. [Time frame: 5 years]
- To compare distant metastases-free survival (dmFS) between study arms [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- Localized adenocarcinoma (cN0M0) of the prostate treated primarily with radical prostatectomy with definitive intent.
- Either persistent PSA after prostatectomy (PSA ≥ 0.1 ng/mL at least 6 weeks after prostatectomy), or biochemical progression (two consecutive rising PSA amounts with a PSA >0.1 ng/mL , or three consecutive PSA rises)
- WHO PS 0-1
- Age ≥18 years
- Ability to understand and willingness to sign a study-specific informed consent prior to study entry
- Ability to understand and answer the EPIC-26 form in one of the languages available
Exclusion criteria
- Patients with a pT4 tumor at prostatectomy
- Patients with previously pathologically confirmed N1
- Patients with macroscopically involved margin at surgery (R2)
- Patients with a history of distant metastases
- Patients with a recurrence visible on imaging (local, pelvic, or distant). Pelvic nodes with a small diameter >1cm and/or positive on PSMA without other explanation, are considered as a pelvic recurrence.
- Latest PSA > 2ng/ml
- Patients with a IPSS >20
- Gleason 10 tumor
- Prior history of high-intensity focused ultrasound ablation (HIFU), cryosurgery or brachytherapy of the prostate
- Prior pelvic radiotherapy
- Prior hormonal therapy started more than 6 weeks before randomization
- History of inflammatory bowel disease, ataxia telangiectasia, prior rectal or bladder surgery.
- Other active malignancy, except non-melanoma skin cancer, superficial bladder cancer, or malignancies with a documented disease-free survival for a minimum of 3 years before randomization.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Belgium · 13 centers
- AZorg — Aalst
- Ziekenhuis Aan de Stroom (ZAS) — Antwerp
- AZ Sint Jan — Bruges
- Jules Bordet Institute, H.U.B — Brussels
- Ziekenhuis Oost-Limburg (ZOL) Campus Sint-Jan — Genk
- UZ Gent — Ghent
- Jessa Ziekenhuis — Hasselt
- AZ Groeninge — Kortrijk
- … and 5 more centers
Identifiers
NCT: NCT06523634 · CE3764