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

STATUS

Recruiting
End date

Mar 5, 2025
participants needed

300
sponsor

Grupo de Investigación Clínica en Oncología Radioterapia

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Updated on 19 February 2024

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ct scan

adenocarcinoma

carcinoma

lymphadenectomy

bone scan

prostatectomy

digital rectal examination

adenocarcinoma of prostate

prostate carcinoma

immunological adjuvant

adjuvant

lymph node disease

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.

Description

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 / 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 / of 10 Gy and a conservative / 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.

Details

Condition	Malignant neoplasm of prostate, Prostatic disorder
Age	18-100 years
Treatment	hypofractionated postoperative radiation therapy
Clinical Study Identifier	NCT04484038
Sponsor	Grupo de Investigación Clínica en Oncología Radioterapia
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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

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