To hear about similar clinical trials, please enter your email below
Trial Title:
Salvage Stereotactic Body Radiotherapy of the Prostate Bed for Biochemical Recurrence After Radical Prostatectomy.
NCT ID:
NCT06523634
Condition:
Prostate Cancer
Conditions: Official terms:
Recurrence
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Non-inferiority randomized controlled trial
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
stereotactic body radiotherapy
Description:
5 fractions
- Treatment every other day (36 to 80 hours between fractions). An overall treatment
time (OTT) of 10-11 days should be aimed for.
- PTV_high: 32Gy
- PTV_low: 25Gy
Arm group label:
SBRT
Intervention type:
Radiation
Intervention name:
SOC RT
Description:
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)
- PTV_high: 52.5Gy
- PTV_low: 44Gy
- Normofractionated: 32-35 fractions
- Daily treatment (OTT 7-8 weeks)
- PTV_high: between 64 and 70Gy (2Gy per fraction)
- PTV_low: between 54 and 57.75Gy
Arm group label:
Control
Summary:
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 of prostate bed in 5 fractions.
2. Control arm: Radiotherapy treatment of prostate bed 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).
Criteria for eligibility:
Criteria:
INCLUSION CRITERIA
1. Localized adenocarcinoma (cN0M0) of the prostate treated primarily with radical
prostatectomy with definitive intent.
2. 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)
3. WHO PS 0-1
4. Age ≥18 years
5. Ability to understand and willingness to sign a study-specific informed consent
prior to study entry
6. Ability to understand and answer the EPIC-26 form in one of the languages available
EXCLUSION CRITERIA
1. Patients with a pT4 tumor at prostatectomy
2. Patients with previously pathologically confirmed N1
3. Patients with macroscopically involved margin at surgery (R2)
4. Patients with a history of distant metastases
5. 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.
6. Latest PSA > 2ng/ml
7. Patients with a IPSS >20
8. Gleason 10 tumor
9. Prior history of high-intensity focused ultrasound ablation (HIFU), cryosurgery or
brachytherapy of the prostate
10. Prior pelvic radiotherapy
11. Prior hormonal therapy started more than 6 weeks before randomization
12. History of inflammatory bowel disease, ataxia telangiectasia, prior rectal or
bladder surgery.
13. 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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
December 1, 2024
Completion date:
December 1, 2030
Lead sponsor:
Agency:
Jules Bordet Institute
Agency class:
Other
Source:
Jules Bordet Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06523634
