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Hypofractionated Radiotherapy Versus Stereotactic Irradiation With Hyaluronic Acid (RPAH2)

Primary Purpose

Prostatic Adenocarcinoma

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Moderate hypofractionated radiotherapy
Stereotactic radiotherapy
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Adenocarcinoma focused on measuring Prostate, Hypofractionated radiotherapy, Stereotactic irradiation, Spacer, Rectal and bladder toxicities

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • age superior or equal to 18 years and inferior to 80 years.
  • patient with a low- to intermediate-risk prostate cancer, according to D'Amico classification, for an exclusive irradiation.
  • prostate cancer histologically proven.
  • performance index OMS (World Health Organization) of grade 0-2.
  • indication of external beam radiotherapy validate by the medical commission of the institution.
  • IPSS (International Prostate Symptom Score < 15/35 (without alpha-blocker).
  • the signed consent form.

Exclusion Criteria:

  • Rectal surgery antecedents.
  • prostate resection less than 6 mois.
  • Involvement of the seminal vesicles or of the capsule on MRI.
  • patient who can't cooperate during the treatment.
  • pelvic irradiation antecedents.
  • antecedents of inflammatory intestinal pathologies.
  • neoplasia.
  • patients treated with anti-neoplastic or anti-angiogenic or with other treatments used in rheumatology and which may include methotrexate (in order not to have a radiosensitizing effect).
  • patients receiving anticoagulant treatment.
  • other undergoing study that may interfere with the present study.
  • patient under legal protection measure.
  • hypersensitivity to hyaluronic acid.
  • patient with auto-immune disease.
  • patient receiving immunosuppressive medication.
  • severe allergies.
  • history of endocarditis.

Sites / Locations

  • Clinique Claude Bernard Service de radiothérapie CMCO Claude Bernard
  • Centre Georges Francois Leclerc
  • Institut Paoli Calmettes
  • Site Hospitalier Nord Boulevard Jacques Monod
  • Centre Hospitalier Lyon Sud
  • Institut de Cancérologie de la Loire
  • Groupe ONCORAD Clinique Pasteur

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Moderate Hypofractionated radiotherapy (62Gy)

Stereotactic radiotherapy (37.5Gy)

Arm Description

20 fractions of 3.1Gy

5 fractions of 7.5Gy)

Outcomes

Primary Outcome Measures

Number of patients with late urinary toxicities of grade ≥ 2 after moderate hypofractionated radiotherapy (62Gy in 20 fractions of 3.1Gy) and after stereotactic radiotherapy (37.5Gy in 5 fractions of 7.5Gy).
Late urinary toxicities of grade ≥ 2 assessed using the Common Toxicity Criteria for Adverse Effects ( CTCAE) v 4.0 classification from 3 months to 3 years.

Secondary Outcome Measures

Survival rates without biological relapse in both arms.
Survival rates without biological relapse (increase of the PSA (prostate-specific antigen) beyond nadir + 2 ng/ml, using Phoenix definition).
Evaluation and comparison of the acute urinary and rectal toxicities in both arms.
all toxicities will be listed using Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0.
Evaluation and comparison of the sexual preservation rates in both arms.
evaluation and comparison of the sexual preservation rates in both arms using International Index of Erectile Function (IIEF).
Late rectal toxicities in both arms, for the evaluation of the hyaluronic acid efficacy to preserve the rectal wall in both approaches.
Late rectal toxicities in both arms, for the evaluation of the hyaluronic acid efficacy to preserve the rectal wall in both approaches, using Common Toxicity Criteria for Adverse Effects (CTCAE) 4.0.

Full Information

First Posted
February 6, 2015
Last Updated
March 2, 2022
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02361515
Brief Title
Hypofractionated Radiotherapy Versus Stereotactic Irradiation With Hyaluronic Acid
Acronym
RPAH2
Official Title
Moderate Hypofractionated Radiotherapy (62 Gy in 20 Fractions of 3.1 Gy) Versus Stereotactic Radiotherapy (37.5 Gy in 5 Fractions of 7.5 Gy) With Hyaluronic Acid Injection Between the Prostate and the Rectum for Prostate Cancer of Low- to Intermediate Risk; RPAH2
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
January 2020 (Actual)
Study Completion Date
January 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The present randomized, open, multicentric Phase II trial, in parallel groups with two arms of treatment, compares the treatment A, moderate hypofractionated radiotherapy of 62Gy, to treatment B, stereotactic irradiation of 37.5 Gy with hyaluronic acid injection in the space between the prostate and the rectum to preserve the rectal-wall from high doses of irradiation. The study aims to assess the rates of late urinary toxicities of grade ≥ 2 induced by a moderate hypofractionated radiotherapy (62Gy in 20 fractions of 3.1Gy) and by a stereotactic radiotherapy (37.5Gy in 5 fractions of 7.5Gy), and the rectal toxicities after an injection of hyaluronic acid between the rectal wall and the prostate. Ninety-six patients and 9 centers are included in the protocol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Adenocarcinoma
Keywords
Prostate, Hypofractionated radiotherapy, Stereotactic irradiation, Spacer, Rectal and bladder toxicities

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Moderate Hypofractionated radiotherapy (62Gy)
Arm Type
Active Comparator
Arm Description
20 fractions of 3.1Gy
Arm Title
Stereotactic radiotherapy (37.5Gy)
Arm Type
Experimental
Arm Description
5 fractions of 7.5Gy)
Intervention Type
Radiation
Intervention Name(s)
Moderate hypofractionated radiotherapy
Intervention Description
Moderate hypofractionated radiotherapy of 62Gy in 20 fraction of 3.1Gy.
Intervention Type
Radiation
Intervention Name(s)
Stereotactic radiotherapy
Intervention Description
Stereotactic radiotherapy of 37.5Gy in 5 fraction of 7.5Gy.
Primary Outcome Measure Information:
Title
Number of patients with late urinary toxicities of grade ≥ 2 after moderate hypofractionated radiotherapy (62Gy in 20 fractions of 3.1Gy) and after stereotactic radiotherapy (37.5Gy in 5 fractions of 7.5Gy).
Description
Late urinary toxicities of grade ≥ 2 assessed using the Common Toxicity Criteria for Adverse Effects ( CTCAE) v 4.0 classification from 3 months to 3 years.
Time Frame
Follow-up at ≥ 3 months after the radiotherapy and up to 3 years.
Secondary Outcome Measure Information:
Title
Survival rates without biological relapse in both arms.
Description
Survival rates without biological relapse (increase of the PSA (prostate-specific antigen) beyond nadir + 2 ng/ml, using Phoenix definition).
Time Frame
3 years.
Title
Evaluation and comparison of the acute urinary and rectal toxicities in both arms.
Description
all toxicities will be listed using Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0.
Time Frame
3 months: evaluation at 3 months.
Title
Evaluation and comparison of the sexual preservation rates in both arms.
Description
evaluation and comparison of the sexual preservation rates in both arms using International Index of Erectile Function (IIEF).
Time Frame
3 years.
Title
Late rectal toxicities in both arms, for the evaluation of the hyaluronic acid efficacy to preserve the rectal wall in both approaches.
Description
Late rectal toxicities in both arms, for the evaluation of the hyaluronic acid efficacy to preserve the rectal wall in both approaches, using Common Toxicity Criteria for Adverse Effects (CTCAE) 4.0.
Time Frame
3 years.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age superior or equal to 18 years and inferior to 80 years. patient with a low- to intermediate-risk prostate cancer, according to D'Amico classification, for an exclusive irradiation. prostate cancer histologically proven. performance index OMS (World Health Organization) of grade 0-2. indication of external beam radiotherapy validate by the medical commission of the institution. IPSS (International Prostate Symptom Score < 15/35 (without alpha-blocker). the signed consent form. Exclusion Criteria: Rectal surgery antecedents. prostate resection less than 6 mois. Involvement of the seminal vesicles or of the capsule on MRI. patient who can't cooperate during the treatment. pelvic irradiation antecedents. antecedents of inflammatory intestinal pathologies. neoplasia. patients treated with anti-neoplastic or anti-angiogenic or with other treatments used in rheumatology and which may include methotrexate (in order not to have a radiosensitizing effect). patients receiving anticoagulant treatment. other undergoing study that may interfere with the present study. patient under legal protection measure. hypersensitivity to hyaluronic acid. patient with auto-immune disease. patient receiving immunosuppressive medication. severe allergies. history of endocarditis.
Facility Information:
Facility Name
Clinique Claude Bernard Service de radiothérapie CMCO Claude Bernard
City
Albi
ZIP/Postal Code
81000
Country
France
Facility Name
Centre Georges Francois Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Institut Paoli Calmettes
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Site Hospitalier Nord Boulevard Jacques Monod
City
Nantes
ZIP/Postal Code
44805
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
Institut de Cancérologie de la Loire
City
St Etienne
ZIP/Postal Code
42270
Country
France
Facility Name
Groupe ONCORAD Clinique Pasteur
City
Toulouse
ZIP/Postal Code
31300
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
32307017
Citation
Jmour O, Benna M, Champagnol P, Ben Mrad M, Hamrouni A, Obeid L, Lahmamssi C, Bousarsar A, Vial N, Rehailia-Blanchard A, Sotton S, Lan M, Langrand-Escure J, Vallard A, Magne N. CBCT evaluation of inter- and intra-fraction motions during prostate stereotactic body radiotherapy: a technical note. Radiat Oncol. 2020 Apr 19;15(1):85. doi: 10.1186/s13014-020-01534-2.
Results Reference
derived

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Hypofractionated Radiotherapy Versus Stereotactic Irradiation With Hyaluronic Acid

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