Back to resultsRadiation-hormone and Docetaxel VS Radiation-hormone in Patients With High-Risk Localized Prostate Cancer (QRT-SOGUG)
Primary Purpose
Prostate Cancer Stage III, Prostate Cancer Stage IV
Status
Active
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Docetaxel
Hormone and radiation therapy
Radiation therapy
Sponsored by
About this trial
This is an interventional prevention trial for Prostate Cancer Stage III
Eligibility Criteria
Inclusion Criteria:
- Histological confirmation of adenocarcinoma of the prostate.
- Age > 18 years.
Localized high-risk prostate cancer, defined as:
- Stage III: T3 N0 M0, Gleason grade 8, 9, or 10, or
- Stage IV: T4 N0 M0, any Gleason grade or Tx N1 M0, any Gleason grade
- PSA > 20 ng/mL.
- Karnofsky index ≥ 70%
- Good bone marrow reserve, with white blood cell count > 3000/mm3, hemoglobin >9.5 g/dL and platelets > 150,000/mm3.
- Absence of hepatic abnormality, with bilirubin values < 1.5 mg/dL and with SGOT/SGPT values up to 2 times the upper limit of normality for each site.
- Absence of abnormality in renal function, with creatinine levels up to 2 times the upper limit of normality for each site.
- Having given informed consent in writing.
Exclusion Criteria:
- Previous hormone treatment during more than 3 months.
- Previous surgical treatment, pelvic radiation therapy, or chemotherapy for the current illness.
- Concomitant second neoplasm or history of neoplastic disease in the last 5 years, except for cutaneous basal cell carcinoma.
- Metabolic disease or uncontrolled systemic disease.
- Previous history of grade III-IV neuropathy (NCI CTCAE v3).
- Psychological, social, family, or geographical conditions that may compromise compliance with or follow-up of the study.
- Having received treatment with an investigational medicinal product during the 30 days prior to inclusion in the study.
- Inflammatory bowel disease.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Docetaxel, hormone and radiation therapy
Hormone and radiation therapy
Arm Description
Radiation therapy combined with weekly docetaxel (20 mg/m2) and hormone therapy.
Radiation therapy and hormone therapy
Outcomes
Primary Outcome Measures
Percentage of patients free of biochemical recurrence within 5 years of receiving a combination of radiation therapy with docetaxel associated with hormone therapy or the standard of care of radiation therapy and hormone therapy
Percentage of patients free of elevation of PSA by 2 ng/mL above the minimum level reached since treatment (biochemical reccurrence), calculating the at-call event, i.e., the date of last confirmatory test (Phoenix criteria).
Secondary Outcome Measures
Percentage of patients with biochemical recurrence-free survival
The duration of survival, in months, between randomization of the patient in the study and the date of recurrence by PSA. In the remaining patients, the last available follow-up will be taken as the last control
Percentage of patients with progression-free survival
The duration of survival, in months, between randomization of the patient in the study and the date of recurrence by PSA, clinical manifestations or death due to disease. In the remaining patients, the last available follow-up will be taken as the last control
Percentage of patients with overall survival.
Defined as the time that elapses, in months, between randomization of the patient in the study and the date of death, regardless of the cause. In the remaining patients, the last available follow-up will be taken as the last control.
Clinical response rate
The clinical response rate: percentage of patients with partial and complete response, according to RECIST criteria.
Biochemical response rate.
Biochemical response rate: percentage of patients with partial and complete response, according to PSA levels.
Quality of life of the patients
Change from baseline in the Quality of Life Questionnaire C30 scale (QLQ-C30) to week 9. The QLQ-c30 has five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale. They are assigned values between 1 and 4 (1: nothing, 2: a few, 3: enough, 4: a lot) according to the patient's responses to the item, only in items 29 and 30 are assessed with a score from 1 to 7 (1: terrible, 7: excellent). The obtained scores are summed and standardized and gets a score between 0 and 100
Safety profile of the treatment.
Numbers of events evaluated according to NCI criteria CTCAE v3
Full Information
NCT ID
NCT03432780
First Posted
January 15, 2018
Last Updated
January 20, 2021
Sponsor
Spanish Oncology Genito-Urinary Group
Collaborators
Pivotal S.L.
1. Study Identification
Unique Protocol Identification Number
NCT03432780
Brief Title
Radiation-hormone and Docetaxel VS Radiation-hormone in Patients With High-Risk Localized Prostate Cancer
Acronym
QRT-SOGUG
Official Title
Randomized Phase II Clinical Study of Radiation Therapy, Hormone Therapy and Chemotherapy With Docetaxel Versus Radiation Therapy and Hormone Therapy in Patients With High-Risk Localized Prostate Cancer (Stage III and IV)"
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 18, 2008 (Actual)
Primary Completion Date
November 14, 2023 (Anticipated)
Study Completion Date
November 14, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spanish Oncology Genito-Urinary Group
Collaborators
Pivotal S.L.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A prospective, multicenter, parallel-group, open-label, randomized, phase II Clinical Study of Radiation Therapy, Hormone Therapy and Docetaxel Versus Radiation Therapy and Hormone Therapy in Patients with High-Risk Localized Prostate Cancer (Stage III and IV) whose primary objective is determine the percentage of patients free of biochemical recurrence within 5 years of receiving a combination of radiation therapy with docetaxel associated with hormone therapy or the standard of care of radiation therapy and hormone therapy in patients with stage III and IV localized prostate cancer with a poor prognosis.
Detailed Description
Randomized Phase II Clinical Study of Radiation Therapy, Hormone Therapy and Chemotherapy with Docetaxel Versus Radiation Therapy and Hormone Therapy in Patients with High-Risk Localized Prostate Cancer (Stage III and IV) Primary Objective: To determine the percentage of patients free of biochemical recurrence within 5 years of receiving a combination of radiation therapy with docetaxel associated with hormone therapy or the standard of care of radiation therapy and hormone therapy in patients with stage III and IV localized prostate cancer with a poor prognosis.
Design: A prospective, multicenter, multidisciplinary, parallel-group, open-label study with randomized group assignment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer Stage III, Prostate Cancer Stage IV
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
A prospective, multicenter, multidisciplinary, parallel-group, open-label study with randomized group assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
134 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Docetaxel, hormone and radiation therapy
Arm Type
Experimental
Arm Description
Radiation therapy combined with weekly docetaxel (20 mg/m2) and hormone therapy.
Arm Title
Hormone and radiation therapy
Arm Type
Active Comparator
Arm Description
Radiation therapy and hormone therapy
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Type
Biological
Intervention Name(s)
Hormone and radiation therapy
Intervention Type
Radiation
Intervention Name(s)
Radiation therapy
Primary Outcome Measure Information:
Title
Percentage of patients free of biochemical recurrence within 5 years of receiving a combination of radiation therapy with docetaxel associated with hormone therapy or the standard of care of radiation therapy and hormone therapy
Description
Percentage of patients free of elevation of PSA by 2 ng/mL above the minimum level reached since treatment (biochemical reccurrence), calculating the at-call event, i.e., the date of last confirmatory test (Phoenix criteria).
Time Frame
5 years of randomization
Secondary Outcome Measure Information:
Title
Percentage of patients with biochemical recurrence-free survival
Description
The duration of survival, in months, between randomization of the patient in the study and the date of recurrence by PSA. In the remaining patients, the last available follow-up will be taken as the last control
Time Frame
5 years
Title
Percentage of patients with progression-free survival
Description
The duration of survival, in months, between randomization of the patient in the study and the date of recurrence by PSA, clinical manifestations or death due to disease. In the remaining patients, the last available follow-up will be taken as the last control
Time Frame
5 years
Title
Percentage of patients with overall survival.
Description
Defined as the time that elapses, in months, between randomization of the patient in the study and the date of death, regardless of the cause. In the remaining patients, the last available follow-up will be taken as the last control.
Time Frame
5 years
Title
Clinical response rate
Description
The clinical response rate: percentage of patients with partial and complete response, according to RECIST criteria.
Time Frame
5 years
Title
Biochemical response rate.
Description
Biochemical response rate: percentage of patients with partial and complete response, according to PSA levels.
Time Frame
5 years
Title
Quality of life of the patients
Description
Change from baseline in the Quality of Life Questionnaire C30 scale (QLQ-C30) to week 9. The QLQ-c30 has five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale. They are assigned values between 1 and 4 (1: nothing, 2: a few, 3: enough, 4: a lot) according to the patient's responses to the item, only in items 29 and 30 are assessed with a score from 1 to 7 (1: terrible, 7: excellent). The obtained scores are summed and standardized and gets a score between 0 and 100
Time Frame
screening and week 9
Title
Safety profile of the treatment.
Description
Numbers of events evaluated according to NCI criteria CTCAE v3
Time Frame
5 years
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
prostate cancer is present only in male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histological confirmation of adenocarcinoma of the prostate.
Age > 18 years.
Localized high-risk prostate cancer, defined as:
Stage III: T3 N0 M0, Gleason grade 8, 9, or 10, or
Stage IV: T4 N0 M0, any Gleason grade or Tx N1 M0, any Gleason grade
PSA > 20 ng/mL.
Karnofsky index ≥ 70%
Good bone marrow reserve, with white blood cell count > 3000/mm3, hemoglobin >9.5 g/dL and platelets > 150,000/mm3.
Absence of hepatic abnormality, with bilirubin values < 1.5 mg/dL and with SGOT/SGPT values up to 2 times the upper limit of normality for each site.
Absence of abnormality in renal function, with creatinine levels up to 2 times the upper limit of normality for each site.
Having given informed consent in writing.
Exclusion Criteria:
Previous hormone treatment during more than 3 months.
Previous surgical treatment, pelvic radiation therapy, or chemotherapy for the current illness.
Concomitant second neoplasm or history of neoplastic disease in the last 5 years, except for cutaneous basal cell carcinoma.
Metabolic disease or uncontrolled systemic disease.
Previous history of grade III-IV neuropathy (NCI CTCAE v3).
Psychological, social, family, or geographical conditions that may compromise compliance with or follow-up of the study.
Having received treatment with an investigational medicinal product during the 30 days prior to inclusion in the study.
Inflammatory bowel disease.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26309896
Citation
Armstrong CM, Gao AC. Drug resistance in castration resistant prostate cancer: resistance mechanisms and emerging treatment strategies. Am J Clin Exp Urol. 2015 Aug 8;3(2):64-76. eCollection 2015.
Results Reference
result
PubMed Identifier
12126818
Citation
Bolla M, Collette L, Blank L, Warde P, Dubois JB, Mirimanoff RO, Storme G, Bernier J, Kuten A, Sternberg C, Mattelaer J, Lopez Torecilla J, Pfeffer JR, Lino Cutajar C, Zurlo A, Pierart M. Long-term results with immediate androgen suppression and external irradiation in patients with locally advanced prostate cancer (an EORTC study): a phase III randomised trial. Lancet. 2002 Jul 13;360(9327):103-6. doi: 10.1016/s0140-6736(02)09408-4.
Results Reference
result
PubMed Identifier
9276357
Citation
Lawton CA, Winter K, Byhardt R, Sause WT, Hanks GE, Russell AH, Rotman M, Porter A, McGowan DG, DelRowe JD, Pilepich MV. Androgen suppression plus radiation versus radiation alone for patients with D1 (pN+) adenocarcinoma of the prostate (results based on a national prospective randomized trial, RTOG 85-31). Radiation Therapy Oncology Group. Int J Radiat Oncol Biol Phys. 1997 Jul 15;38(5):931-9. doi: 10.1016/s0360-3016(97)00288-5.
Results Reference
result
PubMed Identifier
15143084
Citation
Kumar P, Perrotti M, Weiss R, Todd M, Goodin S, Cummings K, DiPaola RS. Phase I trial of weekly docetaxel with concurrent three-dimensional conformal radiation therapy in the treatment of unfavorable localized adenocarcinoma of the prostate. J Clin Oncol. 2004 May 15;22(10):1909-15. doi: 10.1200/JCO.2004.02.001.
Results Reference
result
PubMed Identifier
15470213
Citation
Tannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, Oudard S, Theodore C, James ND, Turesson I, Rosenthal MA, Eisenberger MA; TAX 327 Investigators. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004 Oct 7;351(15):1502-12. doi: 10.1056/NEJMoa040720.
Results Reference
result
PubMed Identifier
15470214
Citation
Petrylak DP, Tangen CM, Hussain MH, Lara PN Jr, Jones JA, Taplin ME, Burch PA, Berry D, Moinpour C, Kohli M, Benson MC, Small EJ, Raghavan D, Crawford ED. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med. 2004 Oct 7;351(15):1513-20. doi: 10.1056/NEJMoa041318.
Results Reference
result
PubMed Identifier
8620502
Citation
Hennequin C, Giocanti N, Favaudon V. Interaction of ionizing radiation with paclitaxel (Taxol) and docetaxel (Taxotere) in HeLa and SQ20B cells. Cancer Res. 1996 Apr 15;56(8):1842-50.
Results Reference
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PubMed Identifier
9815644
Citation
Mason KA, Hunter NR, Milas M, Abbruzzese JL, Milas L. Docetaxel enhances tumor radioresponse in vivo. Clin Cancer Res. 1997 Dec;3(12 Pt 1):2431-8.
Results Reference
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PubMed Identifier
16985954
Citation
Kumar P. A new paradigm for the treatment of high-risk prostate cancer: radiosensitization with docetaxel. Rev Urol. 2003;5 Suppl 3(Suppl 3):S71-7.
Results Reference
result
Links:
URL
https://gco.iarc.fr/
Description
GLOBOCAN 2002
URL
https://gco.iarc.fr/
Description
Base de datos de Mortalidad de la OMS
URL
http://www.nccn.org/professionals/physician_gls/PDF/prostate.pdf
Description
Nacional Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology - v2.2005 (prostate cancer).
Learn more about this trial
Radiation-hormone and Docetaxel VS Radiation-hormone in Patients With High-Risk Localized Prostate Cancer
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