Ultrahypofractionated salvage radiotherapy to a local recurrence after radical prostatectomyAndrogen deprivation therapy
Ultrahypofractionated salvage radiotherapy to a local recurrence after radical prostatectomy: Ultrahypofractioned radiotherapy for patients with isolated local recurrence after radical prostatectomy in 5 fractions
Androgen deprivation therapy: In combination to the radiotherapy a short term androgen deprivation drug for 6 months will be applied.
The preferred 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
Alternatively the following oral drug concept can be used, if the patient rejects injections:
\- GnRH (gonadotropin-releasing hormone)-antagonist with tablet intake for 6 months (e.g. Orgovyx® Tablets 120mg; first day 360mg, after second day 120mg per day)
Study 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
Sex
MALE
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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 outcome measure(s)
Biochemical relapsefree survival — 2 years The initial prostate specific antigen (PSA) at time of registration will be the starting point. Freedom from biochemical progression is counted from the day of registration to the day of either first recorded biochemical progression as defined below, clinical progression or death due to clinical progression.
Biochemical relapsefree survival measured with PSA (prostate specific antigen) lab testing at 1, 3, 6, 12, 18 and 24 months after radiotherapy. The duration of biochemical relapsefree survival is measured and documented in months for each patient.
A biochemical recurrence is defined by any confirmed PSA rise above 0.20 ng/mL with a confirmatory rise at least 2 weeks later. For those patients whose PSA does not drop below 0.20 ng/mL at time of first response assessment at 3 months are considered as non-responders to treatment and are considered to have a biochemical recurrence in case a second measurement at least 2 weeks later confirms a rising PSA above this level.
Trial sites (5)
Facility
City
Region
Status
Universitätsspital Basel
Basel
Switzerland
Istituto Oncologico della Svizzera Italiana-Ente Ospedaliero Cantonale (IOSI-EOC)
Bellinzona
Switzerland
Inselgruppe AG, Inselspital
Bern
Switzerland
Kantonsspital Winterthur, Klinik für Radio-Onkologie
Winterthur
Switzerland
Universitätsspital Zürich, Klinik für Radio-Onkologie
Zurich
Switzerland
More Insel Gruppe AG, University Hospital Bern trials in Switzerland
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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