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

NCT ID: NCT01620710

Last Updated: 2018-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2017-09-30

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

prostate bed

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

Group Type: OTHER

hypofractionated helical IMRT

Intervention Type: RADIATION

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

hypofractionated helical IMRT

Intervention Type: RADIATION

helical IMRT of the prostate bed (18 x 3 Gy) and the pelvic lymph nodes (18 x 2.5 Gy)

prostate bed & lymph nodes

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)

Group Type: OTHER

hypofractionated helical IMRT

Intervention Type: RADIATION

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

hypofractionated helical IMRT

Intervention Type: RADIATION

helical IMRT of the prostate bed (18 x 3 Gy) and the pelvic lymph nodes (18 x 2.5 Gy)

Interventions

hypofractionated helical IMRT

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

Intervention Type: RADIATION

hypofractionated helical IMRT

helical IMRT of the prostate bed (18 x 3 Gy) and the pelvic lymph nodes (18 x 2.5 Gy)

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Heidelberg University

OTHER

Sponsor Role: lead

Responsible Party

Klaus Herfarth, MD

Principal Inverstigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Klaus Herfarth, MD

Role: PRINCIPAL_INVESTIGATOR

Heidelberg University

Locations

Dep. of Radiation Oncology, University Hospital of Heidelberg

Heidelberg, , Germany

Countries

Germany

References

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.

Reference Type: RESULT

PMID: 25216858 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23114055 (View on PubMed)

Other Identifiers

PRIAMOS

Identifier Type: -

Identifier Source: org_study_id