Hyaluronic Acid for Hypofractionated Prostate Radiotherapy (RPAH1)
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|ClinicalTrials.gov Identifier: NCT02165020|
Recruitment Status : Unknown
Verified October 2016 by Hospices Civils de Lyon.
Recruitment status was: Active, not recruiting
First Posted : June 17, 2014
Last Update Posted : October 5, 2016
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Device: Hyaluronic acid (Macrolane VRF 30®, Q-MED)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hypofractionated Radiotherapy for Prostate Cancer (62 Gy in 20 Fractions of 3.1 Gy) With Hyaluronic Acid Injection|
|Study Start Date :||November 2010|
|Estimated Primary Completion Date :||May 2017|
|Estimated Study Completion Date :||May 2017|
Experimental: Rectal toxicities after prostate hypofractionated radiotherapy
Rectal toxicities after prostate hypofractionated radiotherapy with hyaluronic acid
Device: Hyaluronic acid (Macrolane VRF 30®, Q-MED)
One injection of 3 to 10 cc of hyaluronic acid (Macrolane VRF 30®, Q-MED) introduced in the perirectal fat between the rectum and the prostate in connection with an ultrasound.
The injection is performed under local anesthesia (with "Lidocaine") and ultrasound guidance, using a 16 gauge needle.
- Number of patients with late rectal toxicities (> 3 months) of grade ≥ 2 after hypofractionated radiotherapy of prostate cancer of 62 Gy in 20 fractions of 3.1 Gy with an injection of hyaluronic acid (HA) in the space between the rectum and the prostate. [ Time Frame: Follow-up at 3 months and 6 months after the radiotherapy and then every 6 months up to 3 years. ]Late rectal toxicities of grade ≥ 2 assessed using the CTCAE v 4.0 classification from 3 months to 3 years.
- Number of patients with acute rectal toxicities of all grades and of grade ≥ 2. [ Time Frame: 3 years ]Number of patients with acute rectal toxicities of all grades and of grade ≥ 2 (using the CTCAE v 4.0), as a measure of safety and tolerability.
- Tolerance of the HA injection [ Time Frame: 3 years ]The evaluation of the tolerance of the HA injection, as a measure of safety and tolerability (using the CTCAE v 4.0).
- Number of patients with acute and late toxicities, other than the rectal toxicities. [ Time Frame: 3 years ]Number of patients with acute and late toxicities (using the CTCAE v 4.0), other than the rectal toxicities, as a measure of safety and tolerability.
- The evaluation of the biochemical control [ Time Frame: 3 years: evaluation at 3 months, 6 months and then every 6 months during the 3 years. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02165020
|Hospices Civils de Lyon|
|Lyon, France, 69002|