Clinical trial · Interventional
Efficacy of Repeat Stereotactic Radiation in Patients With Intraprostatic Tumor Recurrence
Phase I/II Multi-center Study Evaluating the Efficacy of Repeat Stereotactic Radiation in Patients With Intraprostatic Tumor Recurrence After External Radiation Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Local Recurrence of Malignant Tumor of Prostate | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Body Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- SBRT at a total dose of 30 Gy
- description
- Placement of fiducials marker seeds in the prostate followed by the administration of stereotactic body radiotherapy at 30 Gy (5 sessions at a level of 6 Gy each- 1 session per day) 30 Gy is the first dose-level. During the treatment phase of the study, no study specific visits are scheduled and the patients will be followed as per standard of care.
- interventionNames
- Radiation: Stereotactic Body Radiotherapy
- type
- EXPERIMENTAL
- label
- SBRT at a total dose of 25 Gy
- description
- Placement of fiducials marker seeds in the prostate followed by the administration of stereotactic body radiotherapy at 25 Gy (5 sessions at a level of 5 Gy each- 1 session per day) During the treatment phase of the study, no study specific visits are scheduled and the patients will be followed as per standard of care.
- interventionNames
- Radiation: Stereotactic Body Radiotherapy
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDPasquier D, Le Deley MC, Tresch E, Cormier L, Duterque M, Nenan S, Lartigau E. GETUG-AFU 31: a phase I/II multicentre study evaluating the safety and efficacy of salvage stereotactic radiation in patients with intraprostatic tumour recurrence after external radiation therapy-study protocol. BMJ Open. 2019 Aug 2;9(8):e026666. doi: 10.1136/bmjopen-2018-026666. PMID 31377694