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The present Phase II study aims to assess the rates of late rectal toxicities 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. Thirty-six patients with a low- to intermediate-risk prostate cancer according to the D'Amico classification are included in the present protocol. The main characteristics of the study are that the patients benefit of a reduction of the treatment duration from 40 to 20 fractions, due to the hypofractionated irradiation, and of an injection of 3 to 10 cc of hyaluronic acid in the perirectal fat between the rectum and the prostate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rectal toxicities after prostate hypofractionated radiotherapy | Experimental | Rectal toxicities after prostate hypofractionated radiotherapy with hyaluronic acid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyaluronic acid (Macrolane VRF 30®, Q-MED) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Late rectal toxicities of grade ≥ 2 assessed using the CTCAE v 4.0 classification from 3 months to 3 years. | Follow-up at 3 months and 6 months after the radiotherapy and then every 6 months up to 3 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with acute rectal toxicities of all grades and of grade ≥ 2. | 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. | 3 years |
| Tolerance of the HA injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospices Civils de Lyon | Lyon | 69002 | France |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
The evaluation of the tolerance of the HA injection, as a measure of safety and tolerability (using the CTCAE v 4.0). |
| 3 years |
| Number of patients with acute and late toxicities, other than the rectal toxicities. | 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. | 3 years |
| The evaluation of the biochemical control | 3 years: evaluation at 3 months, 6 months and then every 6 months during the 3 years. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |