Studie zur Sicherheit und Wirksamkeit einer gezielten, hochdosierten Bestrahlung eines einzelnen wiederauftretenden Tumorknotens im Prostatabett nach ursprünglicher Prostataentfernung

Radiation: Ultrahypofractionated salvage radiotherapy to a local recurrence after radical prostatectomy;Drug: Androgen deprivation therapy

Gender: Male
Maximum age: 100 Years
Minimum age: 18 Years
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)