- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01620710
Safety Study of a Shorter (Hypofractionated) Radiotherapy for the Prostate Bed With or Without the Pelvic Lymph Nodes (PRIAMOS)
Hypofractionated Helical Intensity-Modulated Radiotherapy of the Prostate Bed After Prostatectomy With or Without the Pelvic Lymph Nodes - the PRIAMOS Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Heidelberg, Germany, 69120
- Dep. of Radiation Oncology, University Hospital of Heidelberg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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 |
hypofractionated helical IMRT of the prostate bed, 18 x 3 Gy
helical IMRT of the prostate bed (18 x 3 Gy) and the pelvic lymph nodes (18 x 2.5 Gy)
|
Other: 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)
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hypofractionated helical IMRT of the prostate bed, 18 x 3 Gy
helical IMRT of the prostate bed (18 x 3 Gy) and the pelvic lymph nodes (18 x 2.5 Gy)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
proportion SDR of patients with no grade III/IV toxicity and/or treatment discontinuation
Time Frame: 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
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2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall survival
Time Frame: 2 years
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2 years
|
|
biochemical recurrence free survival (BFS)
Time Frame: 2 years
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2 years
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Quality of Life
Time Frame: 2 years
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Quality of Life Scores as measured by the EORTC-QLQ30 and -PR25 questionnaires
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2 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Klaus Herfarth, MD, Heidelberg University
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRIAMOS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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