Status:
ACTIVE_NOT_RECRUITING
Efficacy of Repeat Stereotactic Radiation in Patients With Intraprostatic Tumor Recurrence
Lead Sponsor:
UNICANCER
Conditions:
Local Recurrence of Malignant Tumor of Prostate
Eligibility:
MALE
18+ years
Phase:
NA
Brief 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 o...
Detailed Description
To date, no standard local treatment exists for patients with an intraprostatic recurrence after radiotherapy. A number of treatments options exist including: radical prostatectomy, brachytherapy, Hig...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2030
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT03438552
Start Date
October 18 2018
End Date
November 1 2030
Last Update
December 20 2024
Active Locations (12)
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1
Centre François Baclesse
Caen, France, 14000
2
Centre Jean Perrin
Clermont-Ferrand, France, 63011
3
Centre George François Leclerc
Dijon, France, 21079
4
Centre Oscar Lambret
Lille, France, 59020