Safety Study of a Shorter (Hypofractionated) Radiotherapy for the Prostate Bed With or Without the Pelvic Lymph Nodes

Study Overview
=================
Brief Summary
-----------------
This trial investigates safety and feasibility of a hypofractionated radiotherapy (i.e. with higher daily doses and shorter total treatment time compared to standard fractionation) of the prostate bed with or without the pelvic lymph nodes.

Detailed Description
-----------------
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.

Official Title
-----------------
Hypofractionated Helical Intensity-Modulated Radiotherapy of the Prostate Bed After Prostatectomy With or Without the Pelvic Lymph Nodes - the PRIAMOS Trial

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Radiation: hypofractionated helical IMRT
* Radiation: hypofractionated helical IMRT


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: prostate bed<br>irradiation of the prostatic bed only (no higher risk of lymph node recurrence); helical IMRT of the prostate bed (18 x 3 Gy) This arm has already finished recruitment | Radiation: hypofractionated helical IMRT<br>* hypofractionated helical IMRT of the prostate bed, 18 x 3 Gy<br>Radiation: hypofractionated helical IMRT<br>* helical IMRT of the prostate bed (18 x 3 Gy) and the pelvic lymph nodes (18 x 2.5 Gy)<br>|
| Other: prostate bed & lymph nodes<br>irradiation of the prostatic bed and the pelvic lymphatic drainage (in patients with higher risk of lymph node recurrence); helical IMRT of the prostate bed (18 x 3 Gy) and the pelvic lymph nodes (18 x 2.5 Gy) | Radiation: hypofractionated helical IMRT<br>* hypofractionated helical IMRT of the prostate bed, 18 x 3 Gy<br>Radiation: hypofractionated helical IMRT<br>* helical IMRT of the prostate bed (18 x 3 Gy) and the pelvic lymph nodes (18 x 2.5 Gy)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion SDR of patients with no grade III/IV toxicity and/or treatment discontinuation | 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 | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biochemical recurrence free survival (BFS) |  | 2 years | 
| Quality of Life | Quality of Life Scores as measured by the EORTC-QLQ30 and -PR25 questionnaires | 2 years | 
| overall survival |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prostatectomy