Charité HT-Prostate

Inclusion Criteria:

1. Lymph node negative adenocarcinoma of the prostate treated with radical prostatectomyat least 12 weeks before randomization. Tumour stage pT2a-3b, R0-1, pN0 or cN0according to the UICC TNM 2009; Gleason score available.

2. PSA progression after prostatectomy defined as two consecutive rises with the finalPSA > 0.1 ng/ml or three consecutive rises. The first value must be measured at least 4 weeks after radical prostatectomy.

3. PSA at randomization ≤ 2 ng/ml.

4. No evidence of macroscopic local recurrence or metastatic disease on pre-sRT-MRI (magnetic resonance imaging; with i.v. contrast) or pre-sRT-CT (multislice computedtomography with i.v. and oral contrast) of the abdomen and pelvis assessed within 16weeks prior to randomization.

5. WHO performance status 0-1 at randomization.

6. Age at randomization between 18 and 80 years.

7. Informed consent.

Exclusion Criteria:

1. Persistent PSA value 4-20 weeks after radical prostatectomy > 0.4 ng/ml.

2. Palpable mass in the prostatic fossa, unless histology proves no evidence ofrecurrence.

3. Pelvic lymph node enlargement >1 cm in short axis diameter of the abdomen and pelvis (cN1), unless the enlarged lymph node is sampled and negative.

4. Presence or history of bone metastases. Bone scan is mandatory in cases of clinicalsuspicion (e.g., bone pain).

5. Other malignancies within five years before planned sRT; non-melanoma skin cancers areallowed.

6. ADT or bilateral orchiectomy.

7. Previous pelvic radiotherapy.

8. Hip prosthesis.

9. Metal clusters/markers and patients with a pacemaker.

10. Severe or active co-morbidities impairing the feasibility of hyperthermia or doseintensified sRT including (but not exclusively limited to):

• chronic inflammatory bowel disease

• acute bacterial or fungal infection requiring intravenous antibiotics at the timeof randomization

• unstable angina pectoris and/or congestive heart failure requiringhospitalization within the last 6 months

• transmural myocardial infarction within the last 6 months

• chronic obstructive pulmonary disease exacerbation or other respiratory disordersrequiring hospitalization or precluding planned treatment within the study at thetime of randomization

• psychiatric disorder precluding understanding of information on trial-relatedtopics, giving informed consent or filling out QoL questionnaires

11. Concurrent treatment with other experimental drugs or other anti-cancer therapy;treatment in a clinical trial within 30 days prior to trial entry.