A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following Surgery (STEEL)

STATUS

Recruiting
End date

Sep 15, 2029
participants needed

242
sponsor

RTOG Foundation, Inc.

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Updated on 13 March 2022

See if I qualify

platelet count

prostatectomy

gonadotropin

androgens

growth factor

testosterone

antiandrogen therapy

androgen suppression

bicalutamide

prostate specific antigen

antiandrogens

luteinizing hormone-releasing hormone agonist

enzalutamide

serum testosterone

recurrent prostate cancer

adenocarcinoma

gonadorelin

Summary

Patients with post-prostatectomy PSA (Prostate Specific Antigen) recurrences with aggressive disease features will receive salvage radiation therapy and standard androgen deprivation therapy (ADT) or enhanced ADT to determine if there is any improvement in progression-free survival when enhanced ADT is used compared to standard ADT.

Description

PRIMARY OBJECTIVE:

To determine whether, in men with post-prostatectomy PSA (prostate specific antigen) recurrences with aggressive disease features, salvage radiotherapy (SRT) with enhanced androgen deprivation therapy (ADT), consisting of enzalutamide (MDV3100) and a GnRH analog, will improve progression-free survival compared to SRT with standard GnRH analog -based ADT.

Details

Condition	Prostate Cancer
Treatment	bicalutamide, radiation therapy, Enzalutamide, GnRH analog
Clinical Study Identifier	NCT03809000
Sponsor	RTOG Foundation, Inc.
Last Modified on	13 March 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Pathologically (histologically) proven adenocarcinoma confirmed by prostatectomy performed within 10 years prior to registration and any type of radical prostatectomy is permitted, including retropubic, perineal, laparoscopic or robotically assisted
	PSA level (≥ 0.2 ng/mL) within 90 days prior to registration. GnRH analog may be started no more than 42 days prior study entry, but patients must have a PSA ≥ 0.2 ng/mL prior to starting ADT
	Hemoglobin ≥ 9.0 g/dL, independent of transfusion and/or growth factors within 90 days prior to registration
	Platelet count ≥ 75,000 x 10^9/µL independent of transfusion and/or growth factors within 90 days prior to registration
	At least 1 of the following aggressive features
	Gleason score of 8-10 (note any Gleason score is eligible)
	Seminal vesicle invasion (SVI) (note any pT stage [AJCC v8.0] is eligible but a pT stage
	≥ pT3b is considered aggressive)
	Locoregional node involvement at radical prostatectomy (pN1)
	Persistently elevated PSA post-RP nadir (PEPP) defined as PSA > 0.1 ng/mL after radical prostatectomy
	Serum albumin ≥ 3.0 g/dL within 90 days prior to registration
	GFR ≥35 mL/min estimated by Cockcroft-Gault or measured directly by 24 hour urine creatinine within 90 days prior to registration
	Serum total bilirubin ≤1.5 × ULN (Note: In subjects with Gilbert's syndrome, if total bilirubin is >1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤1.5 × ULN, subject is eligible) within 90 days prior to registration
	Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <2.5 × ULN within 90 days prior to registration
	Testosterone >50 ng/dL within 90 days prior to registration. Prior androgen deprivation (GnRH analog and/or non-steroidal antiandrogen) therapy is allowed provided that serum testosterone concentration must be ≥ 50 ng/dL prior to registration or starting ADT, whichever occurs first; 5-alpha reductase inhibitors will not impact eligibility, but must be discontinued prior to starting protocol treatment
	History and physical with ECOG Performance Status 0-1 or within 90 days prior to registration
Exclusion Criteria
	Definitive clinical or radiologic evidence of metastatic disease with the exception of locoregional lymph nodes
	Prior invasive malignancy (except non-melanomatous skin cancer carcinoma in situ of the male breast, penis, oral cavity, or stage Ta of the bladder, or stage I completely resected melanoma) unless disease free for a minimum of 2 years)
	Prior systemic chemotherapy for the study cancer. Note: prior chemotherapy for a different cancer is allowable
	Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
	History of any of the following
	Documented inflammatory bowel disease
	Transmural myocardial infarction within the last 4 months prior to registration
	Unstable angina and/or congestive heart failure requiring hospitalization within the last 4 months prior to registration
	New York Heart Association Functional Classification III/IV within 4 months prior to registration
	History of loss of consciousness or transient ischemic attack within 12 months prior to randomization
	History of seizure disorder or condition that may predispose to seizure (e.g. prior cortical stroke or significant brain trauma)
	Known gastrointestinal disorder affecting absorption of oral medications
	Active uncontrolled infection defined as an identified infectious condition that requires active therapy that has not yet been completed
	History of uncontrolled hypertension defined as a sustained systolic blood pressure in excess of 150 mmHg or a sustained diastolic blood pressure in excess of 90 mmHg despite optimized antihypertensive therapy
	History of repeated falls and fractures over the past 12 months that in the opinion of the treating investigator would put the patient at risk for poor bone outcomes from androgen receptor targeted therapy
	HIV positive patients with CD4 count < 200 cells/microliter within 30 days prior to registration OR HIV patients under treatment with highly active antiretroviral therapy (HAART) within 30 days prior to registration regardless of CD4 count. Note: HIV testing is not required for eligibility for this protocol as it is self-reported. This exclusion criterion is necessary because the treatments involved in this protocol may be immunosuppressive and/or interact with HAART

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Study Definition

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A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following Surgery (STEEL)