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

This study has been terminated.
(Poorly recruiting)
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00949962
First received: July 30, 2009
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: antiandrogen therapy
Drug: leuprolide acetate
Radiation: 3-dimensional conformal radiation therapy
Phase 3

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

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Primary Outcome Measures:
  • Biochemical progression-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical progression-free survival [ Designated as safety issue: No ]
  • Distant-metastases-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Acute and late toxicity according to NCI CTCAE version 3.0 [ Designated as safety issue: Yes ]

Enrollment: 87
Study Start Date: October 2009
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I
Patients undergo post-operative conformal external beam irradiation for 6.5 weeks.
Radiation: 3-dimensional conformal radiation therapy
Undergo radiotherapy
Experimental: Arm II
Beginning on day -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.
Drug: antiandrogen therapy
Given systemically
Drug: leuprolide acetate
Given subcutaneously
Radiation: 3-dimensional conformal radiation therapy
Undergo radiotherapy

Detailed 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.

  Eligibility

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00949962

Locations
France
European Organization for Research and Treatment of Cancer
Grenoble, France, 38043
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Principal Investigator: Michel Bolla, MD CHU de Grenoble - Hopital de la Tronche
  More Information

Additional Information:
No publications provided

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00949962     History of Changes
Other Study ID Numbers: EORTC-22043-30041, EU-20950, 2006-002772-17
Study First Received: July 30, 2009
Last Updated: July 3, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Federal Institute for Drugs and Medical Devices
Spain: Agencia Española de Medicamentos y Productos Sanitarios
France: 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

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Leuprolide
Androgen Antagonists
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 30, 2014