Post-operative or Early Salvage XRT and ADT for High Risk PCa

Prostate Cancer Clinical Trial

Official title:

Immediate or Early Salvage Post-operative External Radiotherapy Combined With Concomitant and Adjuvant Hormonal Treatment Versus Immediate or Early Salvage Postoperative External Radiotherapy Alone in pT3a-b R0-1 cN0M0 / pT2R1 cN0M0, Gleason Score 5-10 Prostatic Carcinoma. A Phase III Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00949962
• Other study ID #: EORTC-22043-30041
• Secondary ID: EU-209502006-002
• Status: Terminated
• Phase: Phase 3
• First received: July 30, 2009
• Last updated: July 3, 2014
• Start date: October 2009
• Est. completion date: June 2016

Study information

• Verified date: July 2014
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsGermany: Federal Institute for Drugs and Medical DevicesSpain: Agencia Española de Medicamentos y Productos SanitariosFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)Switzerland: Swiss Agency for Therapeutic Products
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Conformal radiation therapy uses a 3-dimensional (3-D) image of the tumor to help focus thin beams of radiation directly on the tumor. Giving conformal external-beam radiation therapy in higher doses over a shorter period of time may kill more tumor cells and have fewer side effects. Androgens can cause the growth of prostate cancer cells. Hormone therapy, such as leuprolide acetate, may lessen the amount of androgens made by the body. It is not yet known whether radiation therapy is more effective when given together with or without hormone therapy in treating patients with prostate cancer who have undergone surgery.

PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with hormone therapy in treating patients who have undergone surgery for stage I, stage II, or stage III prostate cancer.

Description:

OBJECTIVES:

• To investigate the potential benefit of post-operative radiotherapy with vs without a combined and adjuvant treatment consisting of short-term androgen suppression for improving the biochemical progression-free survival of patients who have undergone radical prostatectomy for stage I-III prostate cancer.

OUTLINE: This is a multicenter study. Patients are stratified according to institution, pathological stage (pT2R1 vs pT3R0 vs pT3R1), Gleason sum (≤ 3+4 vs ≥ 4+3), and WHO performance status (0 vs 1). Within 3 months after radical surgery, patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients undergo post-operative conformal external beam irradiation for 6.5 weeks.

• Arm II: Beginning between days -5 to -3, patients receive an antiandrogen for 2-4 weeks. Beginning on day 0, patients receive leuprolide acetate subcutaneously once (6-month depot) and undergo conformal external beam irradiation 5 times weekly for 6.5 weeks.

Patients undergo quality of life assessments periodically.

After completion of study treatment, patients are followed up every 6 months for 5 years and then yearly thereafter.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 87
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 80 Years

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of prostate cancer

• Clinical stage cT1-2-3a, N0, M0 disease pre-operatively

• Pre-operative PSA = 5 x upper limit of normal

• Presenting the following conditions after radical prostatectomy:

• Gleason sum 5-10

• Pathologic stage pT2R1 (positive surgical margins with at least a tumor trans-section > 2 mm) or pT3a-b (irrespective of margin status)

• Negative lymph node (LN) status (pN0) by LN sampling or LN dissection

• Unknown pathological LN status is not allowed, except for disease classified as cT = cT1c with baseline PSA = 10 ng/mL, Gleason score < 7, and = 12 positive core biopsies < 50%

• Undetectable post-operative PSA within 3 months of surgery

PATIENT CHARACTERISTICS:

• WHO performance status 0-1

• WBC = 3 x 10^9/L

• Hemoglobin = 110 g/L

• Platelet count = 100 x 10^9/L

• No other malignancy except adequately treated basal cell carcinoma of the skin or other malignancy from which the patient has been disease free for at least 5 years

• No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• More than 5 years since prior chemotherapy

• No prior pelvic irradiation

• No prior bilateral orchiectomy

• No prior hormonal treatment except neoadjuvant treatment lasting = 3 months

• No other concurrent anticancer agent or modality

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• antiandrogen therapy
Given systemically
• leuprolide acetate
Given subcutaneously

Radiation:
• 3-dimensional conformal radiation therapy
Undergo radiotherapy

Locations

Country	Name	City	State
France	European Organization for Research and Treatment of Cancer	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemical progression-free survival			No
Secondary	Clinical progression-free survival			No
Secondary	Distant-metastases-free survival			No
Secondary	Overall survival			No
Secondary	Quality of life as assessed by QLQ-C30 and QLQ-PR25 at baseline and at 6 months, 1 year, 2 years, and 5 years after treatment			No
Secondary	Acute and late toxicity according to NCI CTCAE version 3.0			Yes