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

Prostate Cancer Clinical Trial

— PRIAMOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01620710
• Other study ID #: PRIAMOS
• Status: Completed
• Phase: Phase 2
• Start date: February 2012
• Est. completion date: September 30, 2017

Study information

• Verified date: October 2018
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 30, 2017
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

Radiation:
• hypofractionated helical IMRT
hypofractionated helical IMRT of the prostate bed, 18 x 3 Gy
• hypofractionated helical IMRT
helical IMRT of the prostate bed (18 x 3 Gy) and the pelvic lymph nodes (18 x 2.5 Gy)

Locations

Country	Name	City	State
Germany	Dep. of Radiation Oncology, University Hospital of Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	biochemical recurrence free survival (BFS)		2 years
Secondary	Quality of Life	Quality of Life Scores as measured by the EORTC-QLQ30 and -PR25 questionnaires	2 years
Secondary	overall survival		2 years