Status:
COMPLETED
Hypo-fractionated Postoperative IMRT in Prostate Cancer
Lead Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborating Sponsors:
Catholic University of the Sacred Heart
University of Bologna
Conditions:
Prostate Cancer
Eligibility:
MALE
18-79 years
Phase:
NA
Brief Summary
To report the outcome of hypo-fractionated radiotherapy after radical prostatectomy (RP) for prostate cancer (PCa) using IMRT-SIB. 124 patients with PCa at high risk of relapse after RP or diagnosis o...
Detailed Description
To report the outcome of hypo-fractionated radiation therapy after radical prostatectomy (RP) for prostate cancer (PCa) using intensity-modulated radiation treatment with simultaneous integrated boost...
Eligibility Criteria
Inclusion
- \> 18 years
- prior radical prostatectomy with or without lymphadenectomy
- high-risk patients (positive surgical margins, and/or extracapsular extension, and/or seminal vescicle invasion, and/or probability of nodal metastasis \> 7% calculated by the Roach formula after pelvic lymph node dissection with ≤ 13 nodes removed, and/or presence of any positive pelvic nodes) or patients with biochemical relapse (initial post-surgery serum PSA equal or above 0.2 ng/mL with a second confirmatory PSA of the same value)
- ECOG performance status 0-1
- adequate bone marrow function (hemoglobin concentration \> 8 g/dl, white blood cell count \> 3,000/ mm³, platelet count \> 75,000/ mm³)
- pre-treatment computed tomography (CT) scan or magnetic resonance imaging (MRI) of the abdomen and pelvis
- bone scan
- informed consent
Exclusion
- prior pelvic radiotherapy
- distant metastases
- macroscopic residual tumor
- pelvic or para-aortic nodes at re-evaluation imaging after surgery
- secondary malignancies
- genetic syndromes of hyper-radio-sensitivity
- chronic inflammatory bowel disease
- previously treated with androgen deprivation therapy
- previously treated with chemotherapy for prostate cancer
Key Trial Info
Start Date :
September 18 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 18 2014
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT03233672
Start Date
September 18 2007
End Date
September 18 2014
Last Update
March 6 2018
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.