Clinical trial NCT03233672: Hypo-fractionated Postoperative IMRT in Prostate Cancer
Official title: Hypofractionated Post-operative IMRT in Prostate Carcinoma: a Phase I/II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: adjuvant
hypofractionation
IMRT
phase I-II
prostate neoplasms
radiotherapy
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
Collaborators: name: Catholic University of the Sacred Heart
name: University of Bologna
name: Howard University
First posted: 2017-07-28
Enrollment: 124
Sex: MALE
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 (IMRT-SIB).

One hundred and twenty-four patients with PCa at high risk of relapse after RP or diagnosis of biochemical relapse were included in this phase II study (adjuvant: 106 patients, salvage: 18 patients). All 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. Acute and late toxicities were recorded and evaluated according to RTOG (Radiation Therapy Oncology Group) criteria and RTOG-EORTC (European Organization for Research and Treatment of Cancer) scale, respectively.

Median follow-up was 30 months (13-92).

Eligibility criteria: Inclusion Criteria:

* \> 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 Criteria:

* 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

Primary outcomes:
measure: incidence of early treatment-emergent adverse events
timeFrame: < 90 days
Secondary outcomes:
measure: Biochemical relapse free survival
timeFrame: 5 years
measure: incidence of late treatment-emergent adverse events were assessed with Radiation
timeFrame: 5 years
Other outcomes:
measure: First evidence of any pelvic recurrence
timeFrame: 5 years
measure: Metastasis-free survival
timeFrame: 5 years
Locations:
Study officials:
affiliation: Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine-DIMES, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy
name: Alessio G Morganti, MD
role: STUDY_DIRECTOR
References: