beta
Trial Radar AI
Clinical Trial NCT03438552 (STEREO-RE-PRO) for Local Recurrence of Malignant Tumor of Prostate is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
One study matched filter criteria
Card View
Back to Search

Efficacy of Repeat Stereotactic Radiation in Patients With Intraprostatic Tumor Recurrence (STEREO-RE-PRO) 57 Non-Invasive

Active, not recruiting
Clinical Trial NCT03438552 (STEREO-RE-PRO) is an interventional study for Local Recurrence of Malignant Tumor of Prostate that is active, not recruiting. It started on 18 October 2018 with plans to enroll 57 participants. Led by UNICANCER, it is expected to complete by 1 November 2030. The latest data from ClinicalTrials.gov was last updated on 20 December 2024.
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 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...

Show More
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, High-intensity focused ultrasound (HIFU), cryotherapy, and stereotactic radiotherapy. These treatments are associated with a variety of genitourinary and gastrointestinal toxicities and complications. In recent years, stere...Show More
Official Title

Phase I/II Multi-center Study Evaluating the Efficacy of Repeat Stereotactic Radiation in Patients With Intraprostatic Tumor Recurrence After External Radiation Therapy

Conditions
Local Recurrence of Malignant Tumor of Prostate
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • STEREO-RE-PRO
  • GETUG-AFU 31 - UC-0160/1618
  • 2017-A00008-45 (Registry Identifier) (ID RCB number)
NCT ID Number
NCT03438552
Start Date (Actual)
2018-10-18
Last Update Posted
2024-12-20
Completion Date (Estimated)
2030-11
Enrollment (Estimated)
57
Study Type
Interventional
PHASE
N/A
Status
Active, not recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Sequential
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalSBRT at a total dose of 30 Gy
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.
Stereotactic Body Radiotherapy
This radiotherapy may be administered with the CyberKnife® or a linear accelerator allowing stereotactic radiotherapy.
ExperimentalSBRT at a total dose of 25 Gy
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.
Stereotactic Body Radiotherapy
This radiotherapy may be administered with the CyberKnife® or a linear accelerator allowing stereotactic radiotherapy.
ExperimentalSBRT at a total dose of 36 Gy
Placement of fiducials marker seeds in the prostate followed by the administration of stereotactic body radiotherapy at 36 Gy (6 sessions at a level of 6 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.
Stereotactic Body Radiotherapy
This radiotherapy may be administered with the CyberKnife® or a linear accelerator allowing stereotactic radiotherapy.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
Estimate the efficacy of the salvage-SBRT in terms of biochemical relapse-free survival rate
6 years
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
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
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
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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Male
  • 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.

  • 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.

UNICANCER logoUNICANCER
No contact data.
12 Study Locations in 1 Countries
Centre François Baclesse, Caen, 14000, France
Centre Jean Perrin, Clermont-Ferrand, 63011, France
Centre George François Leclerc, Dijon, 21079, France
Centre Oscar Lambret, Lille, 59020, France
Centre Léon Bérard, Lyon, 69008, France
Institut régional du Cancer de Montpellier, Montpellier, 34298 CEDEX 05, France
Groupe Hospitalier Pitié-Salpétrière, Paris, 75013, France
DE CREVOISIER Renaud, Rennes, 35042, France
ICO -Site René Gauducheau, Saint-Herblain, 44805, France
Institut de Cancérologie Lucien Neuwirth, Saint-Priest-en-Jarez, 42270, France
CHRU Henry S.Kaplan, Tours, 37044, France
Institut de Cancérologie de Lorraine, Vandœuvre-lès-Nancy, 54519, France