Prostate Cancer Stage III Clinical Trial
— QRT-SOGUGOfficial 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)"
| Verified date | January 2021 |
| Source | Spanish Oncology Genito-Urinary Group |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 134 |
| Est. completion date | November 14, 2023 |
| Est. primary completion date | November 14, 2023 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: 1. Histological confirmation of adenocarcinoma of the prostate. 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: 1. Previous hormone treatment during more than 3 months. 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. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Spanish Oncology Genito-Urinary Group | Pivotal S.L. |
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. Review. — View 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 — View 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. — View 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. — View Citation
Kumar P. A new paradigm for the treatment of high-risk prostate cancer: radiosensitization with docetaxel. Rev Urol. 2003;5 Suppl 3:S71-7. — View 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 — View 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. — View 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 prostat — View Citation
Tannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, Oudard S, Théodore 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 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | 5 years | |
| Secondary | 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 | 5 years | |
| Secondary | 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. | 5 years | |
| Secondary | Clinical response rate | The clinical response rate: percentage of patients with partial and complete response, according to RECIST criteria. | 5 years | |
| Secondary | Biochemical response rate. | Biochemical response rate: percentage of patients with partial and complete response, according to PSA levels. | 5 years | |
| Secondary | 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 | screening and week 9 | |
| Secondary | Safety profile of the treatment. | Numbers of events evaluated according to NCI criteria CTCAE v3 | 5 years |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
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