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| Name | Class |
|---|---|
| Catholic University of the Sacred Heart | OTHER |
| University of Bologna | OTHER |
| Howard University | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypo-fractionated postoperative IMRT-SIB | Radiation | intensity-modulated radiation treatment with simultaneous integrated boost |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical relapse free survival | Survival free from increase of PSA livel exceeding 0.2 ng/mL for those with post surgical PSA livel of 0.2 ng/mL or lower, and as two consecutive PSA increases for patients with a postsurgical PSA livel of > 0.2 ng/mL | 5 years |
| incidence of late treatment-emergent adverse events were assessed with Radiation |
| Measure | Description | Time Frame |
|---|---|---|
| First evidence of any pelvic recurrence | First evidence of any pelvic recurrence | 5 years |
| Metastasis-free survival | The first evidence of any extrapelvic recurrence of disease |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Late complications were assessed with delete Radiation Morbidity Scoring Scheme of the RTOG/European Organization for Research and Treatment of Cancer (EORTC) |
| 5 years |
| 5 years |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |