Clinical trial NCT05746806: Trial of Ultrahypofractionated Focal Salvage Radiotherapy for Isolated Prostate Bed Recurrence After Radical Prostatectomy
Official title: A Single Arm Phase II Trial of Ultrahypofractionated Focal Salvage Radiotherapy for Isolated Prostate Bed Recurrence After Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Recurrent Prostate Cancer
Keywords: Prostate
Salvage Radiation
Local recurrence
Stereotactic radiotherapy
Hypofractionation
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: University of Bern
name: Debiopharm International SA
name: Werner und Hedy Berger-Janser - Stiftung
First posted: 2023-02-28
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main objective of the trial is to explore the efficacy and safety of combining short-term androgen deprivation therapy (ADT) over 6 months to focal ultrahypofractionated salvage radiotherapy (SRT) delivered in 5 fractions to the site of local recurrence within the prostate bed after radical prostatectomy where multiparametric magnetic resonance imaging (mpMRI) and prostate-specific membrane antigen (PSMA) PET/CT are used to precisely identify the local recurrence and compare it to previously published literature.


Eligibility criteria: Inclusion Criteria:

1. Written informed consent according to ICH/GCP (International Council for Harmonisation/Good Clinical Practice) regulations before registration and prior to any trial specific procedures
2. Age ≥ 18 years at time of registration
3. WHO performance status 0-1
4. Lymph node negative adenocarcinoma of the prostate treated with radical prostatectomy (RP) at least 6 months before trial.Tumor stage pT2a-3b, R0-1, pN0 or cN0. according to the Union for International Cancer Control (UICC) TNM 2009.
5. Evidence of measurable local recurrence at the prostate bed detected by PSMA PET/CT and mpMRI within the last 3 months. In case of unclear local recurrence, a biopsy confirmation is recommended.
6. Patient must have non-metastatic (N0, M0) disease, as defined by a lack of nodal or distant metastases seen on PSMA PET/CT scan
7. Patients must have non-castrate levels of serum testosterone (≥50 ng/dL).
8. Patients must not have previously received hormonal therapy (LHRH agonists, antiandrogen, or both, or bilateral orchiectomy).
9. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

Exclusion Criteria:

1. Persistent PSA (\> 0.4 ng/mL) 4 to 20 weeks after RP
2. Previous hematologic or primary solid malignancy within 3 years prior registration with the exception of curatively treated localized non-melanoma skin cancer
3. Usage of products known to affect PSA levels within 4 weeks prior to start of trial treatment phase including any form of androgen suppression agents and androgen deprivation therapy
4. Bilateral hip prosthesis
5. Severe or active co-morbidity likely to impact on the advisability of SRT
6. Treatment with any experimental drug or participation within a clinical trial within 30 days prior to registration (exception: concurrent participation in the biobank studies is allowed)

Primary outcomes:
measure: Biochemical relapsefree survival
timeFrame: 2 years
Secondary outcomes:
measure: Acute side effects of grade 3 or higher
timeFrame: 90 days
measure: Clinical progression-free survival
timeFrame: 2 years
measure: Metastasis-free survival
timeFrame: 2 years
measure: Late side effects
timeFrame: After 90 days up to 2 years (after acute side effects, see outcome 2)
measure: Quality of life (EORTC Quality of life questionnaire C-30 version 3)
timeFrame: 2 years
measure: Quality of life ( EORTC Quality of life PR25)
timeFrame: 2 years
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Universitätsspital Basel
city: Bellinzona
country: Switzerland
facility: Istituto Oncologico della Svizzera Italiana-Ente Ospedaliero Cantonale (IOSI-EOC)
city: Bern
country: Switzerland
facility: Inselgruppe AG, Inselspital
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur, Klinik für Radio-Onkologie
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich, Klinik für Radio-Onkologie
Study officials:
affiliation: Department of radiation oncology, Bern University Hospital, Inselspital, Berne, Switzerland
name: Mohamed MS Shelan, PD
role: STUDY_DIRECTOR
References: