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Completed

NCT Number: NCT03233672

Hypo-fractionated Postoperative IMRT in Prostate Cancer

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–79 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypo-fractionated postoperative IMRT-SIB

Radiation

intensity-modulated radiation treatment with simultaneous integrated boost

Primary outcomes

  1. incidence of early treatment-emergent adverse events

    Time frame: < 90 days

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

Secondary outcomes

  1. Biochemical relapse free survival

    Time frame: 5 years

    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

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

    Time frame: 5 years

    Late complications were assessed with delete Radiation Morbidity Scoring Scheme of the RTOG/European Organization for Research and Treatment of Cancer (EORTC)

Other outcomes

  1. First evidence of any pelvic recurrence

    Time frame: 5 years

    First evidence of any pelvic recurrence

  2. Metastasis-free survival

    Time frame: 5 years

    The first evidence of any extrapelvic recurrence of disease

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Collaborators

  • Catholic University of the Sacred Heart
  • Howard University
  • University of Bologna

Registry information

Official study title

Hypofractionated Post-operative IMRT in Prostate Carcinoma: a Phase I/II Study

Important dates

Study start
2007
Primary completion
2010
Study completion
2014
First posted
Jul 28, 2017
Registry last updated
Mar 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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