Trial Title:
Trial of Ultrahypofractionated Focal Salvage Radiotherapy for Isolated Prostate Bed Recurrence After Radical Prostatectomy
NCT ID:
NCT05746806
Condition:
Recurrent Prostate Cancer
Conditions: Official terms:
Recurrence
Androgens
Conditions: Keywords:
Prostate
Salvage Radiation
Local recurrence
Stereotactic radiotherapy
Hypofractionation
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Ultrahypofractionated salvage radiotherapy to a local recurrence after radical prostatectomy
Description:
Ultrahypofractioned radiotherapy for patients with isolated local recurrence after
radical prostatectomy in 5 fractions
Arm group label:
Single arm
Intervention type:
Drug
Intervention name:
Androgen deprivation therapy
Description:
In combination to the radiotherapy a short term androgen deprivation drug for 6 months
will be applied.
The drug concept used is:
- LHRH(Luteinizing hormone releasing hormone)-agonist with 3-month subcutaneous depot
injection (e.g. Pamorelin® LA (Triptorelin) 11.25mg s.c.) in combination with
nonsteroidal antiandrogen (e.g. Bicalutamide 50mg/day) as flare protection at least
5 days before and max. 15 days after first LHRH-injection
Arm group label:
Single arm
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.
Criteria for 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
5. Tumor stage pT2a-3b, R0-1, pN0 or cN0 according to the Union for International
Cancer Control (UICC) TNM 2009.
6. 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.
7. Patient must have non-metastatic (N0, M0) disease, as defined by a lack of nodal or
distant metastases seen on PSMA PET/CT scan
8. Patients must have non-castrate levels of serum testosterone (≥50 ng/dL).
9. Patients must not have previously received hormonal therapy (LHRH agonists,
antiandrogen, or both, or bilateral orchiectomy).
10. 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)
Gender:
Male
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Universitätsspital Basel
Address:
City:
Basel
Zip:
4031
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Jens Lustenberger
Phone:
+41613287881
Email:
jens.lustenberger@usb.ch
Facility:
Name:
Istituto Oncologico della Svizzera Italiana-Ente Ospedaliero Cantonale (IOSI-EOC)
Address:
City:
Bellinzona
Zip:
6500
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Thomas Zilli, Prof.
Phone:
+41918119635
Email:
thomas.zilli@eoc.ch
Facility:
Name:
Inselgruppe AG, Inselspital
Address:
City:
Bern
Zip:
3010
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Mohamed MS Shelan, PD
Phone:
+41316322632
Email:
mohamed.shelan@insel.ch
Investigator:
Last name:
Mohamed MS Shelan, PD
Email:
Principal Investigator
Facility:
Name:
Kantonsspital Winterthur, Klinik für Radio-Onkologie
Address:
City:
Winterthur
Zip:
8401
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Daniel Zwahlen, Prof.
Phone:
+41522662645
Email:
daniel.zwahlen@ksw.ch
Facility:
Name:
Universitätsspital Zürich, Klinik für Radio-Onkologie
Address:
City:
Zürich
Zip:
8091
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Matthias Guckenberger, Prof.
Phone:
+41442552930
Email:
matthias.guckenberger@usz.ch
Start date:
March 29, 2023
Completion date:
August 31, 2027
Lead sponsor:
Agency:
Insel Gruppe AG, University Hospital Bern
Agency class:
Other
Collaborator:
Agency:
University of Bern
Agency class:
Other
Collaborator:
Agency:
Debiopharm International SA
Agency class:
Industry
Collaborator:
Agency:
Werner und Hedy Berger-Janser - Stiftung
Agency class:
Other
Source:
Insel Gruppe AG, University Hospital Bern
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05746806
