Prostate Cancer Clinical Trial
Official title:
Multicenter Study of Hypofractionated Postoperative Radiotherapy in Patients Diagnosed With Prostate Carcinoma
NCT number | NCT04484038 |
Other study ID # | HYPORT-ES |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 9, 2019 |
Est. completion date | March 2025 |
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | March 2025 |
Est. primary completion date | March 2022 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
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: - Adjuvant RT: pT3 and / or positive margins with PSA <0.2 ng / ml. Delayed RT is considered (> 6 months from the date of surgery but PSA <0.2 ng / ml). - Rescue RT: exclusive biochemical recurrence, without evidence of macroscopic local, regional or distant disease, after surgery. Biochemical recurrence is considered PSA = 0.2 ng / ml after undetectable levels, confirmed with a subsequent determination. - 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: - - Previous pelvic radiation therapy. - Distant metastasis. - Macroscopic residual tumor. - PSA> 2 ng / ml. - Pathological stage T4. - Lymph node involvement. - Pelvic or para-aortic nodules in the reevaluation images after surgery, except pelvic nodes = 1 cm in their shortest axis. - Indication of pelvic nodal RT. Version 2.0, March 27, 2019 - Severe urinary incontinence at the time of indication for radiotherapy. - Uni / bilateral hip prosthesis - Previous tumors, except non-melanoma skin carcinoma, and which are not free of disease for at least 3 years from the end of the treatment of said neoplasms. Bladder tumors are excluded in all cases. - Genetic hyper-radio-sensitivity syndromes. - Chronic inflammatory bowel disease or partial or radical cystectomy for any reason. - Previously treated with androgen deprivation therapy for a period greater than 3 months. - Previously treated with chemotherapy for prostate cancer. - Life expectancy <5 years or severe comorbidity: unstable angina, congestive heart failure, transmural myocardial infarction requiring admission in the last 6 months, active infectious process, respiratory disease requiring hospitalization, liver failure (Child-Pugh Class B or C), HIV with a CD4 count <200 cells / ml, kidney failure requiring dialysis and immunosuppressed by other causes. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario Torrecárdenas | Almería | |
Spain | Hospital Universitario de Badajoz | Badajoz | |
Spain | ICO Badalona | Badalona | Barcelona |
Spain | H. Sta. Cruz y San Pablo | Barcelona | |
Spain | Instituto Oncológico IMQ | Bilbao | |
Spain | Hospital de Fuenlabrada | Fuenlabrada | Madrid |
Spain | Hospital Universitario San Cecilio | Granada | |
Spain | Hospital Dr. Negrin | Las Palmas de Gran Canaria | Gran Canaria |
Spain | Fundación Jimenez Díaz 1 | Madrid | |
Spain | Fundación Jiménez Díaz 2 | Madrid | |
Spain | Hospital de La Princesa | Madrid | |
Spain | Hospital General Gregorio Marañón | Madrid | Adrid |
Spain | Hospital La Luz | Madrid | |
Spain | Hospital Quirón | Madrid | |
Spain | Hospital Ruber Internacional | Madrid | |
Spain | Hospital Universitario Ramón Y Cajal | Madrid | |
Spain | Complejo Hospitalario de Navarra | Pamplona | |
Spain | Hospital Universitario de San Juan | San Juan | Alicante |
Spain | Hospital Universitario de Santiago | Santiago de Compostela | La Coruña |
Lead Sponsor | Collaborator |
---|---|
Grupo de Investigación Clínica en Oncología Radioterapia |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Secondary | Biochemical failure-free survival | Time elapsed between the date of inclusion in the study and biochemical failure | up to 3 years | |
Secondary | 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 | up to 3 years | |
Secondary | Overall survival | Time elapsed between the date of inclusion in the study and the patient's death from any cause | up to 3 years | |
Secondary | 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 | |
Secondary | 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 |
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