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The objective of this study is to evaluate, in patients diagnosed with prostate cancer who undergo radical prostatectomy and who require postoperative radiotherapy, tolerance in terms of acute and chronic GU and GI toxicity and efficacy in terms of biochemical control and survival, as well as of quality of life, from a hypofractional external radiotherapy scheme, increasing the dose per fraction in a shorter period of time.
What the investigators present in this study is a hypofractionation scheme of 62.5 Gy in 25 daily fractions of 2.5 Gy / day, which was chosen to provide a biological equivalent dose (BED) of 166.67 Gy, comparable to the 163 Gy administered with a scheme Normally divided up to 70 Gy in daily fractions of 2 Gy / day Version 2.0, March 27, 2019
(assuming an α / β ratio of 1.5 Gy for prostate cancer). The BED in risk organs (mainly rectum and bladder) will be governed by the ratio used and will differ depending on whether acute or late toxicity is calculated. If selected an acute α / β of 10 Gy and a conservative α / β for late toxicity of 3 Gy, the standard fractionation will result in an acute BED of 84 Gy versus 78 Gy in the hypofractionation scheme and a BED of 116.67 vs. 114.5 Gy for late toxicity.
Therefore, what the investigators expect is a toxicity profile that is at least similar, if not slightly better, compared to the norm-fractionated scheme of 70 Gy in 35 fractions and similar rates of biochemical control and survival.
To all this is added the use of intensity modulated radiotherapy and image-guided radiotherapy techniques (IGRT) that will allow the investigators to significantly reduce the dose administered to risk organs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMRT, any mode | Other | External radiation therapy with 6-18 MV photons on the 62.5 Gy prostate bed in 25 2.5 Gy fractions (EQD2 71 Gy). Serving per fraction: 2.5 Gy Total fractions: 25 No. fractions / week: 5 Total treatment time: 5 weeks Total nominal dose: 62.5 Gy EQD3 (TRT): 68.75 Gy EQD1.5 (CaP): 71.43 Gy EQD2 (CaP): 68.75 Gy EQD10 (TRA): 65.10 Gy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hypofractionated postoperative radiation therapy | Radiation | The patients included in the study will undergo intensity-modulated radiotherapy, of any modality, and image-guided (IGRT) with an emphasis on tissue preservation and administration precision through the use of devices that guarantee the stability and reproducibility of the same. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-related gastrointestinal and genitourinary acute adverse events | using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 scale. The grades of severity from I (minimum) to V (maximum). | ≤90 days |
| Incidence of late gastrointestinal and genitourinary adverse events | using the Radiation Therapy Oncology Group (RTOG) scale. The grades of severity from 1 (minimum) to 4 (maximum). | up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical failure-free survival | Time elapsed between the date of inclusion in the study and biochemical failure | up to 3 years |
| Disease-free survival (locoregional and / or remote) | Time elapsed between the date of inclusion in the study and the detection of the disease locally, regionally and / or remotely |
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Inclusion Criteria:
Age ≥ 18 years.
ECOG 0-1 status.
Previous radical prostatectomy (any modality will be allowed) with or without lymphadenectomy.
Histological confirmation of prostate adenocarcinoma in the prostatectomy specimen.
pT2-T3 Version 2.0, March 27, 2019
pN0-Nx
Indication of postoperative RT:
PSA levels ≤ 2 ng / ml after, at least 45 days after surgery and 30 days before inclusion in the study.
No clinical evidence of lymph node disease. The presence will be admitted by imaging tests of pelvic nodes ≤ 1 cm in its shortest axis.
No evidence of disease in the prostatic fossa. If you doubt by digital rectal examination or CT, an MRI will be performed.
No evidence of distant disease after performing a thoraco-abdominal-pelvic CT scan and bone scan.
Reasonable follow-up possibilities.
Ability to complete the EPIC-26 questionnaire.
Written informed consent prior to inclusion in the study.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ASUNCION R HERVAS, Investigator | Contact | 0034649039866 | ahervas.hrc@salud.madrid.org | |
| ADELA MARIA López, Data Manager | Contact | 0034656303686 | adelamaria.lopez@salud.madrid.org |
| Name | Affiliation | Role |
|---|---|---|
| ASUNCION R HERVAS, I | Ramon y Cajal University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General Gregorio Marañón | Recruiting | Madrid | Adrid | Spain |
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This is a non-randomized prospective multicenter study of hypofractionated postoperative radiotherapy in patients diagnosed with prostate carcinoma.
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|
| up to 3 years |
| Overall survival | Time elapsed between the date of inclusion in the study and the patient's death from any cause | up to 3 years |
| Cause-specific survival | Time elapsed between the date of inclusion in the study and the patient's death due to prostate cancer or toxicity derived from treatment | up to 3 years |
| Assessment of quality of life for cancer Prostate patients | Use of Expanded Prostate Cancer Index questionnaire (EPIC) 26 | at the start of treatment at 3, 12, 24 and 36 months from the end of treatment |
| Hospital Universitario de San Juan | Recruiting | San Juan | Alicante | Spain |
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| ICO Badalona | Recruiting | Badalona | Barcelona | Spain |
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| Hospital Dr. Negrin | Recruiting | Las Palmas de Gran Canaria | Gran Canaria | Spain |
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| Hospital Universitario de Santiago | Recruiting | Santiago de Compostela | La Coruña | Spain |
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| Hospital de Fuenlabrada | Recruiting | Fuenlabrada | Madrid | Spain |
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| Hospital Universitario Torrecárdenas | Recruiting | Almería | Spain |
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| Hospital Universitario de Badajoz | Recruiting | Badajoz | Spain |
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| H. Sta. Cruz y San Pablo | Recruiting | Barcelona | Spain |
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| Instituto Oncológico IMQ | Recruiting | Bilbao | Spain |
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| Hospital Universitario San Cecilio | Recruiting | Granada | Spain |
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| Hospital Universitario Ramón Y Cajal | Recruiting | Madrid | 2834 | Spain |
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| Fundación Jimenez Díaz 1 | Recruiting | Madrid | Spain |
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| Fundación Jiménez Díaz 2 | Recruiting | Madrid | Spain |
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| Hospital de La Princesa | Recruiting | Madrid | Spain |
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| Hospital La Luz | Recruiting | Madrid | Spain |
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| Hospital Quirón | Recruiting | Madrid | Spain |
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| Hospital Ruber Internacional | Recruiting | Madrid | Spain |
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| Complejo Hospitalario de Navarra | Recruiting | Pamplona | Spain |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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