Radiation-hormone and Docetaxel VS Radiation-hormone in Patients With High-Risk Localized Prostate Cancer
NCT ID: NCT03432780
Last Updated: 2021-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
134 participants
INTERVENTIONAL
2008-12-18
2023-11-14
Brief Summary
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Detailed Description
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Design: A prospective, multicenter, multidisciplinary, parallel-group, open-label study with randomized group assignment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Docetaxel, hormone and radiation therapy
Radiation therapy combined with weekly docetaxel (20 mg/m2) and hormone therapy.
Docetaxel
Hormone and radiation therapy
Radiation therapy
Hormone and radiation therapy
Radiation therapy and hormone therapy
Hormone and radiation therapy
Radiation therapy
Interventions
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Docetaxel
Hormone and radiation therapy
Radiation therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age \> 18 years.
3. 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
4. PSA \> 20 ng/mL.
5. Karnofsky index ≥ 70%
6. Good bone marrow reserve, with white blood cell count \> 3000/mm3, hemoglobin \>9.5 g/dL and platelets \> 150,000/mm3.
7. 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.
8. Absence of abnormality in renal function, with creatinine levels up to 2 times the upper limit of normality for each site.
9. Having given informed consent in writing.
Exclusion Criteria
2. Previous surgical treatment, pelvic radiation therapy, or chemotherapy for the current illness.
3. Concomitant second neoplasm or history of neoplastic disease in the last 5 years, except for cutaneous basal cell carcinoma.
4. Metabolic disease or uncontrolled systemic disease.
5. Previous history of grade III-IV neuropathy (NCI CTCAE v3).
6. Psychological, social, family, or geographical conditions that may compromise compliance with or follow-up of the study.
7. Having received treatment with an investigational medicinal product during the 30 days prior to inclusion in the study.
8. Inflammatory bowel disease.
18 Years
MALE
No
Sponsors
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Pivotal S.L.
INDUSTRY
Spanish Oncology Genito-Urinary Group
OTHER
Responsible Party
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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GLOBOCAN 2002
Base de datos de Mortalidad de la OMS
Other Identifiers
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2008-003554-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
QRT-SOGUG
Identifier Type: -
Identifier Source: org_study_id
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