Prostatic AdenocarcinomaRPAH2NCT02361515
Hypofractionated Radiotherapy Versus Stereotactic Irradiation With Hyaluronic Acid
A study testing Moderate hypofractionated radiotherapy and Stereotactic radiotherapy in people with Prostatic Adenocarcinoma, run by Hospices Civils de Lyon at 7 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostatic Adenocarcinoma
- What is being tested?
- Moderate hypofractionated radiotherapy and Stereotactic radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 7 sitesFrance
- Study dates
- Mar 2015to Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Clinique Claude Bernard Service de radiothérapie CMCO Claude Bernard
Albi, 81000
Centre Georges Francois Leclerc
Dijon, 21079
Institut Paoli Calmettes
Marseille, 13009
Site Hospitalier Nord Boulevard Jacques Monod
Nantes, 44805
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
Institut de Cancérologie de la Loire
Saint-Etienne, 42270
Groupe ONCORAD Clinique Pasteur
Toulouse, 31300
About this study
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
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.
- Conditions
- Prostatic Adenocarcinoma
- Being tested
- Moderate hypofractionated radiotherapy, Stereotactic radiotherapy
- Keywords
- Prostate, Hypofractionated radiotherapy, Stereotactic irradiation, Spacer, Rectal and bladder toxicities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate hypofractionated radiotherapyRadiation
Moderate hypofractionated radiotherapy of 62Gy in 20 fraction of 3.1Gy.
Stereotactic radiotherapyRadiation
Stereotactic radiotherapy of 37.5Gy in 5 fraction of 7.5Gy.
| Study group | Role | What they receive |
|---|---|---|
| Moderate Hypofractionated radiotherapy (62Gy) | Active comparator | 20 fractions of 3.1Gy Receives: Radiation: Moderate hypofractionated radiotherapy |
| Stereotactic radiotherapy (37.5Gy) | Experimental | 5 fractions of 7.5Gy) Receives: Radiation: Stereotactic radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Follow-up at ≥ 3 months after the radiotherapy and up to 3 years.
Secondary outcomes (4)
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).
Measured: 3 years.
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.
Measured: 3 months: evaluation at 3 months.
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).
Measured: 3 years.
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.
Measured: 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionJan 2020
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361515
- Sponsor's protocol ID
- 2014-846
- Acronym
- RPAH2
- Status last verified
- Mar 2022
- First submitted
- 6 Feb 2015
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32307017
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02361515
- Acronym / sponsor ID
- RPAH2 / 2014-846
- Conditions
- Prostatic Adenocarcinoma
- Keywords
- Prostate, Hypofractionated radiotherapy, Stereotactic irradiation, Spacer, Rectal and bladder toxicities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 11 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate Hypofractionated radiotherapy (62Gy) | Active comparator | Radiation: Moderate hypofractionated radiotherapy20 fractions of 3.1Gy |
| Stereotactic radiotherapy (37.5Gy) | Experimental | Radiation: Stereotactic radiotherapy5 fractions of 7.5Gy) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate hypofractionated radiotherapyModerate hypofractionated radiotherapy of 62Gy in 20 fraction of 3.1Gy. | Radiation | Moderate Hypofractionated radiotherapy (62Gy) |
| Stereotactic radiotherapyStereotactic radiotherapy of 37.5Gy in 5 fraction of 7.5Gy. | Radiation | Stereotactic radiotherapy (37.5Gy) |
Primary outcome
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).
Time frame: Follow-up at ≥ 3 months after the radiotherapy and up to 3 years.
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.
4 secondary outcomes
Survival rates without biological relapse in both arms.
Time frame: 3 years.
Evaluation and comparison of the acute urinary and rectal toxicities in both arms.
Time frame: 3 months: evaluation at 3 months.
Evaluation and comparison of the sexual preservation rates in both arms.
Time frame: 3 years.
Late rectal toxicities in both arms, for the evaluation of the hyaluronic acid efficacy to preserve the rectal wall in both approaches.
Time frame: 3 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Derived from this study: PubMed 32307017Jmour 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate hypofractionated radiotherapy and Stereotactic radiotherapy in people with Prostatic Adenocarcinoma, run by Hospices Civils de Lyon at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: Follow-up at ≥ 3 months after the radiotherapy and up to 3 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02361515, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2022.