NCT01620710

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2 prostate-cancer

Timeline
Completed

Started Feb 2012

Typical duration for phase_2 prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 15, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

October 16, 2018

Status Verified

October 1, 2018

Enrollment Period

3.6 years

First QC Date

June 13, 2012

Last Update Submit

October 13, 2018

Conditions

Prostate Cancer

Keywords

prostatectomy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • biochemical recurrence free survival (BFS)

    2 years

  • Quality of Life

    2 years

  • overall survival

    2 years

Study Arms (2)

prostate bed

OTHER

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

prostate bed & lymph nodes

OTHER

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

Interventions

hypofractionated helical IMRTRADIATION

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

prostate bedprostate bed & lymph nodes

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep. of Radiation Oncology, University Hospital of Heidelberg

Heidelberg, 69120, Germany

Location

Related Publications (2)

  • 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.

    PMID: 25216858RESULT

  • 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.

    PMID: 23114055DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Klaus Herfarth, MD

    Heidelberg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Inverstigator

Study Record Dates

First Submitted

June 13, 2012

First Posted

June 15, 2012

Study Start

February 1, 2012

Primary Completion

September 1, 2015

Study Completion

September 30, 2017

Last Updated

October 16, 2018

Record last verified: 2018-10

Locations

DE(1)