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

NCT01819285 | Completed Phase 3

• 1 other identifier: EORTC-30891
• Study Type: interventional
• Target: 985
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neoplasm, Prostate

Keywords

Malignant Neoplasm of Prostate; Tumor-node-metastasis (TNM) Staging Regional Lymph Nodes (N0-2); Not suitable for local treatment with curative intent

Outcome Measures

Primary Outcomes (1)

• Overall survival

  13 years from first patient in

Secondary Outcomes (4)

• Overall symptom free survival time

  13 years from first patient in

• Time until first evidence of distant progression

  13 years from first patient in

• Prognostic importance of pretreatment laboratory data

  13 years from first patient in

• Prognosis of particular sub-groups

  13 years from first patient in

Study Arms (2)

Immediate Endocrine Therapy

ACTIVE COMPARATOR

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.

Procedure: Immediate Orchiectomy or depot LHRH

Delayed Endocrine Therapy

EXPERIMENTAL

Orchiectomy or LHRH Therapy plus (initially) Antiandrogen Therapy. BSRL; CPTR. Treatment delayed until onset of symptoms.

Procedure: Delayed Orchiectomy or depot LHRH

Interventions

Immediate Orchiectomy or depot LHRH PROCEDURE

Immediate Endocrine Therapy

Delayed Orchiectomy or depot LHRH PROCEDURE

Delayed Endocrine Therapy

Eligibility Criteria

• Age: Up to 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Related Publications (1)

• 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 DERIVED

Related Links

• Related Info

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

• Urs Studer, MD

  Insel Gruppe AG, University Hospital Bern

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2013
• First Posted: March 27, 2013
• Study Start: February 1, 1990
• Primary Completion: July 1, 2004
• Study Completion: September 1, 2010
• Last Updated: March 27, 2013

Record last verified: 2013-03