NCT01819285 · CITED IN SOURCE DOCUMENTS

Early Compared With Delayed Hormone Therapy in Treating Patients With Nonmetastatic Prostate Cancer

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2013-03-27

Objectives I. Compare, in a randomized Phase III multi-institutional setting, symptom-free survival time of patients with asymptomatic carcinoma of the prostate (T0-4, N0-2, M0) not suited for local curative treatment who are randomly assigned to immediate vs. delayed endocrine intervention (orchiectomy or luteinizing hormone releasing hormone (LHRH) agonist therapy). II. Compare the overall survival of these two groups of patients. III. Compare the time to first evidence of distant progression (N4 or M1) of these two treatment groups. IV. Evaluate the prognostic significance of pretreatment laboratory data and monitor these parameters following endocrine therapy. V. Study the prognosis of various sub-groups of patients stratified according to performance status, local tumor extent, nodal status, and choice of endocrine treatment.

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What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part

eligibility Criteria: Inclusion Criteria: * Histologically or cytologically proven, newly diagnosed asymptomatic (with the exception of voiding disturbances) carcinoma of the prostate T0-4 N0-2 M0 which is not suitable for local treatment with curative intent (radical prostatectomy, radiation therapy). * All T stages are acceptable (UICC 1982). The stage is determined by rectal palpation. * Patients with regional lymph node metastases smaller than 5 cm (N0-2), determined either by CT or ultrasonography, preferable with cytologic confirmation. * Life expectancy of at least six months. * WHO performance status score 0-1. * Informed consent. Patients must be prepared to undergo an orchiectomy or continuous treatment with a depot LHRH analogue. * Continuous follow-up until death if possible. Exclusion Criteria: * Other malignancies diagnosed during the last 10 years, apart from treated basal cell carcinoma of the skin. * Prostate cancer known for longer than one month before entering the study. * Pain caused by the prostate cancer or its metastases. * Any previous treatment for prostate cancer (radical prostatectomy, radiation therapy, endocrine treatment, etc.) Note: TUR-P for voiding disturbances is allowed at any time and is not an exclusion criterion. * Patients with ureteric obstruction caused by local infiltration of prostatic cancer and other evidence of locally advanced disease which could cause fatal complications if untreated (e.g. rectal stenosis, thrombosis of pelvic veins). * Patients with palpable or juxtaregional lymph node metastasis (paraaortic, supraclavicular, inguinal, N3-4). * Patients with evidence of distant metastases (bone, lung, liver). * Age over 80 years. Performance status WHO score 2, 3 and 4 (any reason). * Patient who refuses orchiectomy or longterm subcutaneous implants of LHRH analogue in two monthly intervals. Expected difficulties with follow-up for any reason.
healthy Volunteers: false
maximum Age: 80 Years
sex: MALE
std Ages: CHILD
ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Immediate Endocrine Therapy. Orchiectomy or LHRH Agonist Therapy plus (initially) Antiandrogen Therapy. Buserelin (BSRL); Cyproterone acetate (Androcur) (CPTR), Cyproterone acetate (Androcur)(NSC-81430). Treatment initiated within 1 month of randomization.
intervention Names
Procedure: Immediate Orchiectomy or depot LHRH
label
Immediate Endocrine Therapy
type
ACTIVE_COMPARATOR
description
Orchiectomy or LHRH Therapy plus (initially) Antiandrogen Therapy. BSRL; CPTR. Treatment delayed until onset of symptoms.
intervention Names
Procedure: Delayed Orchiectomy or depot LHRH
label
Delayed Endocrine Therapy
type
EXPERIMENTAL

interventions

arm Group Labels
Immediate Endocrine Therapy
name
Immediate Orchiectomy or depot LHRH
type
PROCEDURE
arm Group Labels
Delayed Endocrine Therapy
name
Delayed Orchiectomy or depot LHRH
type
PROCEDURE

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 985
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

measure
Overall survival
time Frame
13 years from first patient in

secondary Outcomes

measure
Overall symptom free survival time
time Frame
13 years from first patient in
measure
Time until first evidence of distant progression
time Frame
13 years from first patient in
description
prostate cancer mortality and overall mortality according to pretreatment laboratory data
measure
Prognostic importance of pretreatment laboratory data
time Frame
13 years from first patient in
description
prostate cancer mortality and overall mortality according to particular sub-groups (following stratification factors): performance status (0 vs 1), the local tumor extent (T0-2 vs T3-4), nodal status (N0 vs N1-2), the choice of hormonal therapy.
measure
Prognosis of particular sub-groups
time Frame
13 years from first patient in

Full study description

brief Summary: Objectives I. Compare, in a randomized Phase III multi-institutional setting, symptom-free survival time of patients with asymptomatic carcinoma of the prostate (T0-4, N0-2, M0) not suited for local curative treatment who are randomly assigned to immediate vs. delayed endocrine intervention (orchiectomy or luteinizing hormone releasing hormone (LHRH) agonist therapy). II. Compare the overall survival of these two groups of patients. III. Compare the time to first evidence of distant progression (N4 or M1) of these two treatment groups. IV. Evaluate the prognostic significance of pretreatment laboratory data and monitor these parameters following endocrine therapy. V. Study the prognosis of various sub-groups of patients stratified according to performance status, local tumor extent, nodal status, and choice of endocrine treatment.

Source references

references

citation
Studer UE, Whelan P, Wimpissinger F, Casselman J, de Reijke TM, Knonagel H, Loidl W, Isorna S, Sundaram SK, Collette L; EORTC Genitourinary Cancer Group. Differences in time to disease progression do not predict for cancer-specific survival in patients receiving immediate or deferred androgen-deprivation therapy for prostate cancer: final results of EORTC randomized trial 30891 with 12 years of follow-up. Eur Urol. 2014 Nov;66(5):829-38. doi: 10.1016/j.eururo.2013.07.024. Epub 2013 Jul 24.
pmid
23932338
type
DERIVED