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NCT Number: NCT01148069

Surgery Combined With Intensity Modulated Radiation Therapy - Image-Guided Radiation Therapy (IMRT-IGRT) in Locally-advanced Prostate Cancers

Standard treatment of locally-advanced prostate cancers consists in the association of radiotherapy of prostate and seminal vesicles (SV) and androgen deprivation (AD) for 3 years. This treatment is usually preceded by pelvic lymphadenectomy to assess the possible extension to lymph nodes of prostatic cancer and to avoid irradiating the pelvis in case of no lymph node involvement. However, radiotherapy leads usually to about 30% of grade ≥2 risk of bladder and/or rectal toxicity. This risk particularly depends on the radiation volume. In the aim of lowering the toxicity, the treatment in this study will associate:

* pelvic lymph node dissection and resection of seminal vesicles, allowing decreasing the radiation target volume to the prostate only (and not to irradiate the SV); * a high-precision radiotherapy technique combining Intensity Modulated Radiation Therapy (IMRT) and Image-Guided Radiation Therapy (IGRT).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Centre Eugène Marquis - CRLCC, Rennes, France

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About this study

This study targets non metastatic prostatic locally-advanced adenocarcinomas which are at high risk of both local progression and metastases. The standard treatment of these tumours associates external beam radiation therapy (EBRT) and 3 years of androgen deprivation (AD) with LH-RH analogue. In the absence of AD and mainly when prostate specific antigen (PSA) is >10 ng/ml, several randomized studies have shown that high doses of EBRT increase biochemical control. Nevertheless, escalating the doses of radiation significantly increases the risk of rectal and/or urinary toxicities. In order to lower the toxicity of irradiation in locally-advanced prostate cancers, and to improve the quality of life of patients, this study aims at decreasing the volume of irradiated healthy tissues. To carry out this objective, we will use a double strategy:

  • Limiting the target volume to prostate only by removing seminal vesicles at the time of lymph node dissection,
  • Using a technique of high-precision radiation combining Intensity Modulated Radiation Therapy (IMRT) and Image-Guided Radiation Therapy (IGRT).

Based on the literature, we may assume a toxicity rate of 30% during the three years of hormonotherapy with standard treatment (i.e. without removing seminal vesicles). We make the hypothesis of a 20% absolute reduction of toxicity with our protocol.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age > 18,
  • Prostate adenocarcinoma (histologically proven),
  • Locally-advanced (T3a or Gleason > 7 or PSA ≥ 20 ng/mL),
  • Distal half of seminal vesicles unaffected on MRI,
  • Non metastatic cancer: negative extension assessment (on prostatic and pelvic MRI and bone scintigraphy),
  • Radiotherapy and hormonotherapy indication,
  • Medical insurance affiliation,
  • Written informed consent.

Non-inclusion criteria:

  • Co-morbidity or medical history contraindicating surgery (pelvic lymphadenectomy and seminal vesicle ablation),
  • Contraindication to pelvic irradiation,
  • Hip prosthesis,
  • History of cancer for the last 5 years (except baso-cellular epithelioma),
  • History of pelvic irradiation,
  • Person deprived of freedom or under guardianship,
  • Participation in another biomedical research.

Exclusion criteria

  • Surgery showing lymph nodes involvement (pelvic radiation indication)
  • Surgery without ablation of seminal vesicles
  • Surgery with positive margins in seminal vesicles

Treatment and study plan

Surgery combined with IMRT-IGRT

Procedure

Patients will have surgery consisting in extensive pelvic dissection and ablation of seminal vesicles. Surgery will be followed by prolonged hormonotherapy (3 years) associated, after 2 months, with prostatic only irradiation.

Primary outcomes

  1. Rate of bladder and/or rectal grade ≥2 toxicity (late toxicity)

    Time frame: between 6 months and 3 years

    Rate of bladder and/or rectal grade ≥2 toxicity (CTCAE V4.0) observed between 6 months and 3 years after the beginning of the radiotherapy.

Secondary outcomes

  1. Dose received by the rectum and the bladder with and without seminal vesicles irradiation

    Time frame: Before treatment

    Assessed using a dose-volume histogram

  2. Quality of life

    Time frame: 3 years

    Assessed with EORTC questionnaires (QLQ-C30, QLQ-PR25)

  3. Erectile troubles

    Time frame: 3 years

    Assessed with erectile troubles questionnaire (IIEF-5)

  4. Onset of biological signs evocating a recidive

    Time frame: 3 years

    Assessed with PSA levels

  5. Onset of clinical signs evocating a recidive

    Time frame: 3 years

  6. Specific and global survival

    Time frame: 3 years

  7. Rate of bladder and/or rectal grade ≥2 toxicity (CTCAE V4.0) (early toxicity)

    Time frame: 6 months

    Rate of late bladder and/or rectal grade ≥2 toxicity (CTCAE V4.0) observed 6 months after the beginning of the radiotherapy.

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Collaborators

  • Center Eugene Marquis

Registry information

Official study title

Surgery Combined With IMRT-IGRT in Locally-advanced Prostate Cancers

Acronym: TARGET

Important dates

Study start
2010
Primary completion
2018
Study completion
2018
First posted
Jun 22, 2010
Registry last updated
Dec 19, 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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