Prostate Cancer Clinical Trial
Official title:
Three Dimensional Conformal Radiotherapy / Intensity Modulated Radiotherapy Alone Vs Three Dimensional Conformal Therapy / Intensity Modulated Radiotherapy Plus Adjuvant Hormonal Therapy In Localized T1b-c, T2a, N0, M0 Prostatic Carcinoma. A Phase III Randomized Study
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Bicalutamide and
goserelin may fight prostate cancer by reducing the production of testosterone. It is not
yet known if radiation therapy is more effective with or without bicalutamide and goserelin
in treating prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with
or without bicalutamide and goserelin in treating patients who have localized prostate
cancer.
Status | Completed |
Enrollment | 819 |
Est. completion date | January 2016 |
Est. primary completion date | April 2008 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | N/A to 80 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed stage II prostate cancer - T1b-c, N0, M0 with prostate-specific antigen (PSA) at least 10 ng/mL and/or Gleason score at least 7 (UICC 1997 classification) OR - T2a, N0, M0 (UICC 1997 classification) - Serum PSA no greater than 50 ng/mL - No involvement of pelvic lymph nodes PATIENT CHARACTERISTICS: Age: - 80 and under Performance status: - WHO 0-2 Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Other: - No other malignancy within the past 5 years except adequately treated basal cell skin cancer - No psychological, familial, sociological, or geographical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - No prior hormonal therapy Radiotherapy: - No prior pelvic radiotherapy Surgery: - No prior radical prostatectomy |
Allocation: Randomized, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | Academisch Ziekenhuis der Vrije Universiteit Brussel | Brussels | |
Belgium | Cliniques Universitaires Saint-Luc | Brussels | |
Belgium | U.Z. Gasthuisberg | Leuven | |
Cyprus | Bank Of Cyprus Oncology Centre | Nicosia | |
Czech Republic | Charles University Hospital | Hradec Kralove | |
France | Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz | Besancon | |
France | Centre de Lutte Contre le Cancer Georges-Francois Leclerc | Dijon | |
France | CHU de Grenoble - Hopital de la Tronche | Grenoble | |
France | Centre Paul Strauss | Strasbourg | |
France | Centre d'Oncologie Saint-Yves | Vannes | |
Ireland | Saint Luke's Hospital | Dublin | |
Italy | Spedali Civili di Brescia | Brescia | |
Italy | Istituto Nazionale per la Ricerca sul Cancro | Genoa | |
Luxembourg | Hopital de la Ville D'Esch-sur-Alzette | Esch-sur-Alzette | |
Netherlands | Arnhems Radiotherapeutisch Instituut | Arnhem | |
Netherlands | University Medical Center Groningen | Groningen | |
Netherlands | Dr. Bernard Verbeeten Instituut | Tilburg | |
Poland | Medical University of Gdansk | Gdansk | |
Spain | Institut Catala d'Oncologia - Hospital Duran i Reynals | Barcelona | |
United Kingdom | Belfast City Hospital Trust Incorporating Belvoir Park Hospital | Belfast | Northern Ireland |
Lead Sponsor | Collaborator |
---|---|
European Organisation for Research and Treatment of Cancer - EORTC |
Belgium, Cyprus, Czech Republic, France, Ireland, Italy, Luxembourg, Netherlands, Poland, Spain, United Kingdom,
Matzinger O, Duclos F, van den Bergh A, Carrie C, Villà S, Kitsios P, Poortmans P, Sundar S, van der Steen-Banasik EM, Gulyban A, Collette L, Bolla M; EORTC Radiation Oncology Group. Acute toxicity of curative radiotherapy for intermediate- and high-risk — View Citation
Matzinger O, Poortmans P, Giraud JY, Maingon P, Budiharto T, van den Bergh AC, Davis JB, Musat E, Ataman F, Huyskens DP, Gulyban A, Bolla M; EORTC Radiation Oncology Group. Quality assurance in the 22991 EORTC ROG trial in localized prostate cancer: dummy run and individual case review. Radiother Oncol. 2009 Mar;90(3):285-90. doi: 10.1016/j.radonc.2008.10.022. Epub 2008 Nov 27. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Biochemical and clinical disease-free survival as measured by Logrank prostate-specific antigen progression every 6 months until year 5, and annually thereafter | No | ||
Secondary | Clinical disease-free survival as measured by Logrank every 6 months until year 5, and annually thereafter | No | ||
Secondary | Overall survival as measured by Logrank every 6 months until year 5, and annually thereafter | No | ||
Secondary | Local control as measured by Gray scale every 6 months until year 5, and annually thereafter | No | ||
Secondary | Acute toxicity as measured by NCI-CTC v2.0 up to 1 month post radiotherapy | Yes | ||
Secondary | Late toxicity as measured by EORTC and RTOG every 6 months until year 5, and annually thereafter | Yes | ||
Secondary | Quality of life as measured by EORTC QLQ-C30 and EORTC PR-25 every 6 months until year 5, and annually thereafter | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05540392 -
An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues
|
Phase 1/Phase 2 | |
Recruiting |
NCT05613023 -
A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT
|
Phase 3 | |
Recruiting |
NCT05156424 -
A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT03177759 -
Living With Prostate Cancer (LPC)
|
||
Completed |
NCT01331083 -
A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05540782 -
A Study of Cognitive Health in Survivors of Prostate Cancer
|
||
Active, not recruiting |
NCT04742361 -
Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer
|
Phase 3 | |
Completed |
NCT04400656 -
PROState Pathway Embedded Comparative Trial
|
||
Completed |
NCT02282644 -
Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry
|
N/A | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06305832 -
Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05761093 -
Patient and Physician Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment
|
||
Completed |
NCT04838626 -
Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection
|
Phase 2/Phase 3 | |
Recruiting |
NCT03101176 -
Multiparametric Ultrasound Imaging in Prostate Cancer
|
N/A | |
Completed |
NCT03290417 -
Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer
|
N/A | |
Completed |
NCT00341939 -
Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
|
||
Completed |
NCT01497925 -
Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer
|
Phase 1 | |
Recruiting |
NCT03679819 -
Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
|
||
Completed |
NCT03554317 -
COMbination of Bipolar Androgen Therapy and Nivolumab
|
Phase 2 | |
Completed |
NCT03271502 -
Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy
|
N/A |