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Salvage Stereotactic Body Radiotherapy of the Prostate Bed for Biochemical Recurrence After Radical Prostatectomy.

ConditionProstate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorJules Bordet Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Stereotactic body radiotherapy (SBRT)

    Radiation

    5 fractions of SBRT to the prostate bed with or without whole pelvic radiotherapy Treatment every other day.

  • SOC RT

    Radiation

    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))

Treatment groups

284 Participants
are divided into 2 treatment groups
Group A: ControlActive comparator 1 intervention
Group B: SBRTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

SBRT impact on patient-reported GI and GU symptoms

Urinary and bowel domain of the EPIC-26 (Expanded Prostate Cancer Index Composite).

Time frame
2 years post treatment

Secondary outcomes

1

Patient Reported Outcomes

Patient-reported outcomes according to the different * EPIC-26 domains (0-100) * IPSS score (0-35) * EQ-5D-5L scores (five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression)

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
2

Ccost-utility during radiotherapy

Cost-utility analysis based on EQ-5D-5L (five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression)versus costs of RT and transportation during radiotherapy

Time frame
during radiotherapy
3

Physician-scored toxicity

Physician-scored toxicity according to CTCAE 5.0 (grades) (Early: within 90 days; or late: 90 or more days after SBRT). Proportion of patients with G2+ toxicity will be reported specifically.

Time frame
up to 5 years
4

Blood lymphocyte evolution between study arms

Lymphocyte count nadir relative to baseline

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jules Bordet Institute

Lead sponsor

Source ClinicalTrials.gov
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