Clinical trial NCT06523634: Salvage Stereotactic Body Radiotherapy of the Prostate Bed for Biochemical Recurrence After Radical Prostatectomy.
Official title: Salvage Stereotactic Body Radiotherapy of the Prostate Bed for Biochemical Recurrence After Radical Prostatectomy.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Jules Bordet Institute
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 284
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-inferiority randomized controlled trial
Primary purpose: TREATMENT

Brief 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 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).

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.

Primary outcomes:
measure: SBRT impact on patient-reported GI and GU symptoms
timeFrame: 2 years post treatment
Secondary outcomes:
measure: Patient Reported Outcomes
timeFrame: 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
measure: Ccost-utility during radiotherapy
timeFrame: during radiotherapy
measure: Physician-scored toxicity
timeFrame: up to 5 years
measure: Blood lymphocyte evolution between study arms
timeFrame: 5 years
measure: To compare biochemical progression-free survival (bPFS) to historical control and between study arms
timeFrame: 5 years
measure: To compare local and regional recurrences between study arms, up to 5 years.
timeFrame: 5 years
measure: To compare Overall survival (OS) between study arms, up to 5 years.
timeFrame: 5 years
measure: To compare distant metastases-free survival (dmFS) between study arms
timeFrame: 5 years
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: AZorg
city: Antwerpen
country: Belgium
facility: Ziekenhuis Aan de Stroom (ZAS)
city: Brussels
country: Belgium
facility: Jules Bordet Institute, H.U.B
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
city: La Louvière
country: Belgium
facility: CHU HELORA - Hôpital de La Louvière - site Jolimont
city: Mechelen
country: Belgium
facility: AZ Sint-Maarten
city: Namur
country: Belgium
facility: CHU UCL Namur - Site Elisabeth
Study officials:
References: