Efficacy of Repeat Stereotactic Radiation in Patients With Intraprostatic Tumor Recurrence

NCT03438552 | Active Not Recruiting DMC

• 2 other identifiers: GETUG-AFU 31 - UC-0160/16182017-A00008-45
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 12

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 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

Local Recurrence of Malignant Tumor of Prostate

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Evaluation of acute and late genitourinary toxicities of the salvage-SBRT

  3 years

• Estimate the efficacy of the salvage-SBRT in terms of clinical progression-free survival and overall survival

  6 years

• Evaluation of Quality of life after salvage-SBRT

  6 years

• Evaluation of Quality of life after salvage-SBRT

  6 years

Study Arms (3)

SBRT at a total dose of 30 Gy

EXPERIMENTAL

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.

Radiation: Stereotactic Body Radiotherapy

SBRT at a total dose of 25 Gy

EXPERIMENTAL

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.

Radiation: Stereotactic Body Radiotherapy

SBRT at a total dose of 36 Gy

EXPERIMENTAL

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.

Radiation: Stereotactic Body Radiotherapy

Interventions

Stereotactic Body Radiotherapy RADIATION

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

SBRT at a total dose of 25 Gy; SBRT at a total dose of 30 Gy; SBRT at a total dose of 36 Gy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• UNICANCER: lead

Study Sites (12)

Centre François Baclesse

Caen, 14000, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Centre George François Leclerc

Dijon, 21079, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Léon Bérard

Lyon, 69008, France

Location

Institut régional du Cancer de Montpellier

Montpellier, 34298 CEDEX 05, France

Location

Groupe Hospitalier Pitié-Salpétrière

Paris, 75013, France

Location

DE CREVOISIER Renaud

Rennes, 35042, France

Location

ICO -Site René Gauducheau

Saint-Herblain, 44805, France

Location

Institut de Cancérologie Lucien Neuwirth

Saint-Priest-en-Jarez, 42270, France

Location

CHRU Henry S.Kaplan

Tours, 37044, France

Location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Location

Related Publications (1)

• Pasquier 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 DERIVED

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• David Pasquier

  Centre Oscar Lambret, LILLE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: February 19, 2018
• Study Start: October 18, 2018
• Primary Completion (Estimated): October 15, 2027
• Study Completion (Estimated): November 1, 2030
• Last Updated: December 20, 2024

Record last verified: 2024-12

Locations

FR (12)