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NCT Number: NCT03169933

Combined, Intensified and Modulated Adjuvant Therapy in Prostate Carcinoma

Patients with high risk prostate cancer may benefit from radiotherapy after radical prostatectomy. The investigators postulated that adjuvant androgen deprivation therapy (ADT), radiation dose escalation, and selective pelvic irradiation may improve outcome. A phase II trial was designed to prove that combined-intensified-modulated-adjuvant (CIMA) treatment may improve 5-year biochemical relapse free survival (bRFS) from 75% to 90% in high risk patients. The delivered dose to tumor bed and pelvic nodes was 64.8-70.2 Gy and 45 Gy (57% of patients), respectively, and 69% received ADT.

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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

Prostate cancer patients at high risk of loco-regional recurrences may benefit from postoperative radiotherapy (RT) following radical prostatectomy (EORTC trial 22911). However, despite an improvement in biochemical relapse-free survival (bRFS), the risk of recurrences remained high for those patients. The investigators postulated that adjuvant androgen deprivation therapy (ADT), radiation dose escalation, and selective pelvic irradiation for patients at risk for regional failures may improve the outcome. The combined-intensified-modulated-adjuvant (CIMA) as described may improve survival through a reduction of loco-regional and systemic failures.

A phase II trial was designed to test the hypothesis that CIMA treatment may improve 5-year bRFS by 15%. Patients less than 80 years old, with a histological diagnosis of prostate adenocarcinoma without distant metastases, stage pT2-4 N0-1, no previous treatments and an ECOG performance status of 0-2 were selected. All patients had at least one of these pathologic features: extracapsular extension, positive surgical margins, or seminal vesicle invasion. Radiation dose to the tumor bed ranged from 64.8 to 70.2 Gy. Pelvic lymph nodes were treated to 45 Gy in selected patients at risk of regional failures (57%). Selected patients at risk for distant metastases (69.1%) received hormonal therapy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • < 80 years old
  • histological diagnosis of prostate adenocarcinoma
  • no distant metastases
  • stage pT2-4
  • N0-1
  • ECOG performance status of 0-2
  • One of these pathologic features: extracapsular extension, positive surgical margins, or seminal vesicle invasion. extracapsular extension, positive surgical margins or seminal vesicle invasion, or positive lymph-nodes
  • No surgical complications such as pelvic infections or lymphocele, intraoperative rectal injury or severe urinary incontinence
  • Preoperative and postoperative PSA test, bone scan and CT-scan or MRI of abdomen and pelvis prior to enrolment
  • Normal bone marrow function

Exclusion criteria

  • Previously treated with Radiotherapy
  • Previously treated with androgen deprivation therapy
  • Previously treated with chemotherapy for prostate cancer. They also had to be free

Treatment and study plan

Combined, intensified and modulated adjuvant radiotherapy

Radiation

Other names: adjuvant androgen deprivation therapy

Primary outcomes

  1. Biochemical relapse free survival

    Time frame: Five years

    Survival free from increase of PSA level exceeding 0.2 ng/mL for those with postsurgical PSA level of 0.2 ng/mL or lower, and as two consecutive PSA increases for patients with a postsurgical PSA level of > 0.2 ng/ml

Secondary outcomes

  1. Incidence of early treatment-emergent adverse events

    Time frame: < 90 days.

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

  2. Incidence of late treatment-emergent adverse events were assessed with Radiation Morbidity Scoring Scheme of the RTOG/European Organization for Research and Treatment of Cancer (EORT)

    Time frame: 5 years

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

  3. First evidence of any pelvic recurrence

    Time frame: 5 years

    First evidence of any pelvic recurrence

  4. Metastasis-free survival

    Time frame: 5 years

    The first evidence of any extra pelvic recurrence of disease.

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Collaborators

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

Registry information

Official study title

Combined, Intensified and Modulated Adjuvant Therapy in Prostate Carcinoma: a Phase II Trial

Important dates

Study start
2004
Primary completion
2009
Study completion
2017
First posted
May 30, 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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