Hypo-fractionated Postoperative IMRT in Prostate Cancer

NCT03233672 | Completed DMC

• 1 other identifier: Iside-PP-2
• Study Type: interventional
• Target: 124
• Locations: 0 countries
• Sites: N/A

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 of biochemical relapse were included. Patients received 62.5 Gy to the prostate bed (PB) and 45 Gy to pelvis nodes in 25 fractions. Androgen suppressive therapy was prescribed based on NCCN risk categories. Median follow-up was 30 months.

Conditions

Prostate Cancer

Keywords

adjuvant; hypofractionation; IMRT; phase I-II; prostate neoplasms; radiotherapy

Outcome Measures

Primary Outcomes (1)

• incidence of early treatment-emergent adverse events

  adverse events after radiotherapy. Acute side effets were scored according to the Radiation Therapy Oncology Group (RTOG) scale.

  < 90 days

Secondary Outcomes (2)

• Biochemical relapse free survival

  5 years

• incidence of late treatment-emergent adverse events were assessed with Radiation

  5 years

Other Outcomes (2)

• First evidence of any pelvic recurrence

  5 years

• Metastasis-free survival

  5 years

Study Arms (1)

Hypo-fractionated postoperative IMRT-SIB

OTHER

All patients underwent combined, intensified and modulated radiotherapy for five days a week with the following doses: 62.5 Gy to the prostate bed and 45 Gy to pelvis nodes in 25 fractions.

Radiation: Hypo-fractionated postoperative IMRT-SIB

Interventions

Hypo-fractionated postoperative IMRT-SIB RADIATION

intensity-modulated radiation treatment with simultaneous integrated boost

Hypo-fractionated postoperative IMRT-SIB

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead
• Catholic University of the Sacred Heart: collaborator
• University of Bologna: collaborator
• Howard University: collaborator

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Alessio G Morganti, MD

  Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine-DIMES, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: July 28, 2017
• Study Start: September 18, 2007
• Primary Completion: September 18, 2010
• Study Completion: September 18, 2014
• Last Updated: March 6, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share