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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01620710

Acronym

PRIAMOS

Enrollment

Registered

2012-06-15

Start date

2012-02-29

Completion date

2017-09-30

Last updated

2018-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

prostatectomy

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.

Interventions

RADIATIONhypofractionated helical IMRT

hypofractionated helical IMRT of the prostate bed, 18 x 3 Gy

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026