Radiation-hormone and Docetaxel VS Radiation-hormone in Patients With High-Risk Localized Prostate Cancer

NCT03432780 | Unknown Phase 2

• 2 other identifiers: QRT-SOGUG2008-003554-14
• Study Type: interventional
• Target: 134
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prostate Cancer Stage III; Prostate Cancer Stage IV

Outcome Measures

Primary Outcomes (1)

• 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).

  5 years of randomization

Secondary Outcomes (7)

• Percentage of patients with biochemical recurrence-free survival

  5 years

• Percentage of patients with progression-free survival

  5 years

• Percentage of patients with overall survival.

  5 years

• Clinical response rate

  5 years

• Biochemical response rate.

  5 years

Study Arms (2)

Docetaxel, hormone and radiation therapy

EXPERIMENTAL

Radiation therapy combined with weekly docetaxel (20 mg/m2) and hormone therapy.

Drug: Docetaxel; Biological: Hormone and radiation therapy; Radiation: Radiation therapy

Hormone and radiation therapy

ACTIVE COMPARATOR

Radiation therapy and hormone therapy

Biological: Hormone and radiation therapy; Radiation: Radiation therapy

Interventions

Docetaxel DRUG

Also known as: Taxotere

Docetaxel, hormone and radiation therapy

Hormone and radiation therapy BIOLOGICAL

Docetaxel, hormone and radiation therapy; Hormone and radiation therapy

Radiation therapy RADIATION

Docetaxel, hormone and radiation therapy; Hormone and radiation therapy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: prostate cancer is present only in male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Inflammatory bowel disease.

Sponsors & Collaborators

• Spanish Oncology Genito-Urinary Group: lead
• Pivotal S.L.: collaborator

Related Publications (9)

• 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.

  PMID: 26309896 RESULT

• 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.

  PMID: 12126818 RESULT

• 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.

  PMID: 9276357 RESULT

• 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.

  PMID: 15143084 RESULT

• 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.

  PMID: 15470213 RESULT

• 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.

  PMID: 15470214 RESULT

• 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.

  PMID: 8620502 RESULT

• 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.

  PMID: 9815644 RESULT

• 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.

  PMID: 16985954 RESULT

Related Links

• GLOBOCAN 2002
• Base de datos de Mortalidad de la OMS

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel; Hormones; Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective, multicenter, multidisciplinary, parallel-group, open-label study with randomized group assignment

Study Record Dates

• First Submitted: January 15, 2018
• First Posted: February 14, 2018
• Study Start: December 18, 2008
• Primary Completion: November 14, 2023
• Study Completion: November 14, 2023
• Last Updated: January 22, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share