Hypofractionated Helical Intensity-Modulated Radiotherapy of the Prostate Bed After Prostatectomy With or Without the Pelvic Lymph Nodes - the PRIAMOS Trial
18 Years
80 Years
Male
Prostate Cancer
Trial Information
Hypofractionated Helical Intensity-Modulated Radiotherapy of the Prostate Bed After Prostatectomy With or Without the Pelvic Lymph Nodes - the PRIAMOS Trial
While evidence on safety and efficacy of primary hypofractionated radiotherapy in prostate
cancer is accumulating, data on postoperative hypofractionated treatment of the prostate bed
and of the pelvic lymph nodes is still scarce. This phase II trial was initiated to
investigate safety and feasibility of hypofractionated treatment of the prostate bed alone
or with the pelvic lymph nodes.
A total of 80 prostate cancer patients with the indication for adjuvant radiotherapy will be
enrolled, where 40 patients with a low risk of lymph node involvement (arm 1) and another 40
patients with a high risk of lymph node involvement (arm 2) will each receive 54 Gy in 18
fractions to the prostate bed. Arm 2 will be given 45 Gy to the pelvic lymph nodes
additionally. Helical Tomotherapy and daily image guidance wil be used.
Inclusion Criteria:
- resected prostate carcinoma with histological grading (Gleason Score)
- status post prostatectomy for a pT3 carcinoma and/or R1/2 resection or PSA recurrence
after prostatectomy (2 consecutive PSA rises)
- PSA recurrence ≥ 1 ng/ml: CT/PET/MRI imaging excluding pathological lymph nodes
- Karnofksy performance score ≥ 70 %
- age 18 - 80 years
- only arm 2: antihormonal therapy for 2 months prior to radiotherapy and continuation
of hormonal suppression after radiotherapy recommended
- written informed consent
Exclusion Criteria:
- patient's refusal
- patient's inabillity to give informed consent
- stage IV (distant metastases)
- lymph node involvement outside the pelvis
- severe wound complications after laparatomy
- only arm 2: severe lymphoedema of the legs, elephantiasis, postthrombotic syndrome
- decompensated pulmonary, cardiovascular, metabolic, hematopoetic, coagulatory or
renal comorbidities
- known other malignant disease with distant metastases
- prior pelvic irradiation
- participation in another clinical trial that might compromise the results of the
PRIAMOS trial or the other trial
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
proportion SDR of patients with no grade III/IV toxicity and/or treatment discontinuation
Outcome Description:
Proportion SDR of patients with no NCI CTC AE grade 3-4 toxicity and no discontinuation of treatment during the full set of 18 fractions by any reasons in the intent-to-treat (ITT) population
Outcome Time Frame:
2 years
Safety Issue:
Yes
Principal Investigator
Klaus Herfarth, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Heidelberg
Authority:
Germany: Ethics Commission
Study ID:
PRIAMOS
NCT ID:
NCT01620710
Start Date:
February 2012
Completion Date:
February 2016
Related Keywords:
- Prostate Cancer
- prostatectomy
- Prostatic Neoplasms
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