Clinical trial NCT01620710: Safety Study of a Shorter (Hypofractionated) Radiotherapy for the Prostate Bed With or Without the Pelvic Lymph Nodes
Official title: Hypofractionated Helical Intensity-Modulated Radiotherapy of the Prostate Bed After Prostatectomy With or Without the Pelvic Lymph Nodes - the PRIAMOS Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: prostatectomy
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2012-06-15
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: proportion SDR of patients with no grade III/IV toxicity and/or treatment discontinuation
timeFrame: 2 years
Secondary outcomes:
measure: biochemical recurrence free survival (BFS)
timeFrame: 2 years
measure: Quality of Life
timeFrame: 2 years
measure: overall survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Dep. of Radiation Oncology, University Hospital of Heidelberg
Study officials:
affiliation: Heidelberg University
name: Klaus Herfarth, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Katayama S, Striecker T, Kessel K, Sterzing F, Habl G, Edler L, Debus J, Herfarth K. Hypofractionated IMRT of the prostate bed after radical prostatectomy: acute toxicity in the PRIAMOS-1 trial. Int J Radiat Oncol Biol Phys. 2014 Nov 15;90(4):926-33. doi: 10.1016/j.ijrobp.2014.07.015. Epub 2014 Sep 9.
citation: Krause S, Sterzing F, Neuhof D, Edler L, Debus J, Herfarth K. Hypofractionated helical intensity-modulated radiotherapy of the prostate bed after prostatectomy with or without the pelvic lymph nodes - the PRIAMOS trial. BMC Cancer. 2012 Oct 31;12:504. doi: 10.1186/1471-2407-12-504.