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Active, not recruiting Not applicable

Efficacy of Repeat Stereotactic Radiation in Patients With Intraprostatic Tumor Recurrence

NCT03438552 · tracked via the Priya Life Science France tracker
Sponsor
Phase
Not applicable
Started
2018-10-18
Last updated
2024-12-20

Condition(s) studied

Local Recurrence of Malignant Tumor of Prostate

Investigational drug(s) / intervention(s)

Stereotactic Body Radiotherapy

Stereotactic Body Radiotherapy: This radiotherapy may be administered with the CyberKnife® or a linear accelerator allowing stereotactic radiotherapy.

Study summary

Stereo-Re-Pro aims to provide further evidence of Stereotactic Body Radiotherapy (SBRT) as a supplementary non-invasive curative treatment for local recurrence following radiotherapy.

The objective of the first part of the trial (Phase I) is to select the recommended dose for salvage SBRT (either 5 x 6 Gy, 6 x 6 Gy, or 5 x 5 Gy) based on dose-limiting toxicity observed during the 18 weeks following the initiation of salvage-SBRT. Particular attention will be paid to the quality of life and tolerance of the treatment.

The objective of the second part of the trial (phase II) is to estimate the efficacy of the salvage-SBRT in terms of biochemical relapse-free survival rate.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Biochemical recurrence occurring at least 2 years after external radiotherapy for prostatic adenocarcinoma by the Phoenix definition (PSA nadir + 2 ng/mL) * T1-T2c and PSA ≤20 ng/mL and Gleason score ≤7 at initial diagnosis of prostate cancer before the initial/first treatment. * Recurrence of prostatic adenocarcinoma proven by histology following radiotherapy by transrectal or transperineal sextant biopsies of the two lobes of the prostate, with a minimum of 12 biopsies, irrespective of Gleason score. Biopsies of the seminal vesicles are optional. * Clinical stage T1-T2 on relapse; unilateral extracapsular extension (T3a) on MRI permitted except posteriorly relative to the rectum * Estimated clinical target volume (CTV) / prostate volume \< 0.5 based on imaging and biopsies * Pelvic and prostatic assessment by multiparametric MRI- Absence of pelvic or metastatic recurrence proven by choline PET scan * Performance status World Health Organization (WHO) 0-1 * PSA level ≤10 ng/mL at baseline (before salvage-SBRT) * PSA doubling time \>10 months * International Prostate Cancer Score (IPSS) ≤12 * Uroflowmetry with a maximum flow rate \>10 mL/s, a postvoid residual urine volume \<150 mL, and a urine volume \>150 mL. * No other anti-cancer treatment since the external radiotherapy administered as first-line treatment * No other anti-cancer treatment planned for the current recurrence * No contraindication to fiducial marker implants; haemostatic disorders must be corrected before implantation * Age \>18 years * Life-expectancy greater than or equal to 5 years (Lee scale) * Patient registered with a health insurance system * Patient who has signed the informed consent form * Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures indicated in the protocol. Exclusion Criteria: * Lymph node or metastatic spread * Late post-radiotherapy urinary or gastrointestinal toxicity of grade ≥2 (following primary radiotherapy) * Other cancers in the last 5 years except for non-melanoma-type skin cancer * History of inflammatory bowel disease * Anticoagulant treatment * Contraindications to undergoing MRI * Prostate volume \>80 cc * Transurethral resection of the prostate (TURP) in the 6 months before registrations * Presence of rectal telangiectasia grade 3 classified by the Vienna Rectoscopy Score (obligatory rectoscopy) * Previous rectal surgery * Patients unable to undergo medical follow-up in the study for geographical, social or psychological * Person deprived of their liberty or under protective custody or guardianship * Patients enrolled in another therapeutic study All patients during the SBRT planning with a ratio of clinical target volume (CTV) / prostate volume \>0.5 will be withdrawn from the study. These patients will be considered as not evaluable and will not be treated within the context of the study.

Primary outcome measure(s)

  • Selection of the recommended dose for salvage-SBRT (either 5 x 6 Gy, 6 x 6 Gy, or 5 x 5 Gy) based on dose-limiting toxicity observed during the 18 weeks following the initiation of salvage-SBRT. — 18 weeks
    The dose-escalation part of the study will terminate once 10 patients have been treated and evaluated at a dose currently identified as the recommended dose.
  • Estimate the efficacy of the salvage-SBRT in terms of biochemical relapse-free survival rate — 6 years

Trial sites (12)

FacilityCityRegionStatus
Centre François Baclesse Caen France
Centre Jean Perrin Clermont-Ferrand France
Centre George François Leclerc Dijon France
Centre Oscar Lambret Lille France
Centre Léon Bérard Lyon France
Institut régional du Cancer de Montpellier Montpellier France
Groupe Hospitalier Pitié-Salpétrière Paris France
DE CREVOISIER Renaud Rennes France
ICO -Site René Gauducheau Saint-Herblain France
Institut de Cancérologie Lucien Neuwirth Saint-Priest-en-Jarez France
CHRU Henry S.Kaplan Tours France
Institut de Cancérologie de Lorraine Vandœuvre-lès-Nancy France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03438552 on ClinicalTrials.gov ↗ ← All trials in France