Multicenter Study of Hypofractionated Postoperative Radiotherapy in Patients Diagnosed With Prostate Carcinoma

NCT04484038 | Unknown

• 1 other identifier: HYPORT-ES
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 19

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Radiotherapy, prostate cancer

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

• Biochemical failure-free survival

  up to 3 years

• Disease-free survival (locoregional and / or remote)

  up to 3 years

• Overall survival

  up to 3 years

• Cause-specific survival

  up to 3 years

• Assessment of quality of life for cancer Prostate patients

  at the start of treatment at 3, 12, 24 and 36 months from the end of treatment

Study Arms (1)

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

Radiation: hypofractionated postoperative radiation therapy

Interventions

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.

IMRT, any mode

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Grupo de Investigación Clínica en Oncología Radioterapia: lead

Study Sites (19)

Hospital General Gregorio Marañón

Madrid, Adrid, Spain

RECRUITING

Hospital Universitario de San Juan

San Juan, Alicante, Spain

RECRUITING

ICO Badalona

Badalona, Barcelona, Spain

RECRUITING

Hospital Dr. Negrin

Las Palmas de Gran Canaria, Gran Canaria, Spain

RECRUITING

Hospital Universitario de Santiago

Santiago de Compostela, La Coruña, Spain

RECRUITING

Hospital de Fuenlabrada

Fuenlabrada, Madrid, Spain

RECRUITING

Hospital Universitario Torrecárdenas

Almería, Spain

RECRUITING

Hospital Universitario de Badajoz

Badajoz, Spain

RECRUITING

H. Sta. Cruz y San Pablo

Barcelona, Spain

RECRUITING

Instituto Oncológico IMQ

Bilbao, Spain

RECRUITING

Hospital Universitario San Cecilio

Granada, Spain

RECRUITING

Hospital Universitario Ramón Y Cajal

Madrid, 2834, Spain

RECRUITING

Fundación Jimenez Díaz 1

Madrid, Spain

RECRUITING

Fundación Jiménez Díaz 2

Madrid, Spain

RECRUITING

Hospital de La Princesa

Madrid, Spain

RECRUITING

Hospital La Luz

Madrid, Spain

RECRUITING

Hospital Quirón

Madrid, Spain

RECRUITING

Hospital Ruber Internacional

Madrid, Spain

RECRUITING

Complejo Hospitalario de Navarra

Pamplona, Spain

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• ASUNCION R HERVAS, I

  Ramon y Cajal University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ASUNCION R HERVAS, Investigator

CONTACT

0034649039866; ahervas.hrc@salud.madrid.org

ADELA MARIA López, Data Manager

CONTACT

0034656303686; adelamaria.lopez@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: This is a non-randomized prospective multicenter study of hypofractionated postoperative radiotherapy in patients diagnosed with prostate carcinoma.

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 23, 2020
• Study Start: March 9, 2019
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2025
• Last Updated: July 23, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (19)