Local Recurrence of Malignant Tumor of Prostate Clinical Trial
— STEREO-RE-PROOfficial title:
Phase I/II Multi-center Study Evaluating the Efficacy of Repeat Stereotactic Radiation in Patients With Intraprostatic Tumor Recurrence After External Radiation Therapy
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.
Status | Recruiting |
Enrollment | 47 |
Est. completion date | November 2030 |
Est. primary completion date | November 2024 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | 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 | CHU de Poitiers | Poitiers | |
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 | Vandoeuvre-les-nancy |
Lead Sponsor | Collaborator |
---|---|
UNICANCER |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 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. | 18 weeks | |
Primary | Estimate the efficacy of the salvage-SBRT in terms of biochemical relapse-free survival rate | 6 years | ||
Secondary | Evaluation of acute and late genitourinary toxicities of the salvage-SBRT | Acute and late genitourinary toxicities over the first 3 years according to the NCI-CTCAE V4.03 classification (June 14th, 2010) | 3 years | |
Secondary | Estimate the efficacy of the salvage-SBRT in terms of clinical progression-free survival and overall survival | Clinical progression-free survival is defined as the time interval between the date of registration and the date of clinical progression (local progression assessed by the physical examination, or appearance of metastatic lesions) or death irrespective of the cause. | 6 years | |
Secondary | Evaluation of Quality of life after salvage-SBRT | Quality of life will be evaluated based on the EORTC QLQ-C30. The Time Until Definitive Deterioration (TUDD) will be computed from registration until the first observation of a definitive deterioration of the quality of life, defined as a score decreased by 10 points (in the case of global health scale and functional scales) or increased by 10 points (in the case of symptom scales) compared to the score at baseline, without later improvement superior to 10 points compared to baseline score. | 6 years | |
Secondary | Evaluation of Quality of life after salvage-SBRT | Quality of life will be evaluated based on the EORTC QLQ-PR25. The Time Until Definitive Deterioration (TUDD) will be computed from registration until the first observation of a definitive deterioration of the quality of life, defined as a score decreased by 10 points (in the case of global health scale and functional scales) or increased by 10 points (in the case of symptom scales) compared to the score at baseline, without later improvement superior to 10 points compared to baseline score. | 6 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06201078 -
Stereotactic Re-irradiation of Local Recurrences of Prostate Cancer After Radiotherapy
|
Phase 2 |