|- candidate number||2232|
|- NTR Number||NTR763|
|- Date ISRCTN created||22-nov-2006|
|- date ISRCTN requested||8-nov-2006|
|- Date Registered NTR||6-sep-2006|
|- Secondary IDs||N/A |
|- Public Title||AVOCAT study|
|- Scientific Title||An open-label, prospective, comparative trial to assess PSA progression on bicalutamide monotherapy versus bicalutamide + dutasteride therapy in patients with advanced and/or metastatic carcinoma of the prostate.|
|- ACRONYM||AVOCAT study|
|- hypothesis||To evaluate the difference in percentages of patients with PSA progression treated with either bicalutamide 150 mg/day in monotherapy or bicalutamide 150 mg/day + dutasteride 0.5 mg/day after 3 years of follow-up in patients with locally advanced or metastatic prostate cancer.|
|- Healt Condition(s) or Problem(s) studied||Prostate cancer|
|- Inclusion criteria||1. Patients aged 18 years and above |
2. Patients with histologically proven prostate cancer.
3. Patients with locally advanced carcinoma of the prostate (T3-4, N0-x) or (T0-x, N1-3; N category should be confirmed histologically or cytologically) or metastatic carcinoma of the prostate (M1).
4. Patients with a high (> 10 ng/ml) PSA level at baseline.
5. Written informed consent to participate in the study.
6. Life expectancy is at least 12 months.
|- Exclusion criteria||1. Patients simultaneously participating in another study.|
2. Previous or concurrent chemotherapy, 5-alpha reductase inhibitor therapy or hormonal therapy specifically for the treatment of prostate cancer other than temporary neo-adjuvant hormonal therapy administered longer than 1 year prior to study entry.
3. Development of another invasive neoplastic disease during the previous 5 years, or concomitant presence of another invasive neoplastic disease, except basal cell carcinoma or squamous cell carcinoma of the skin.
4. Patients with a history or presence of hepatic or renal disease or other condition known to interfere with metabolism or excretion of drugs.
5. Patients with a history of alcohol or drug abuse.
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||1-mrt-2006|
|- planned closingdate||31-mrt-2012|
|- Target number of participants||324|
|- Interventions||Group 1 will be hormonally treated with bicalutamide 150 mg/day monotherapy.|
Group 2 will be hormonally treated with bicalutamide 150 mg/day + 0.5 mg dutasteride/day
|- Primary outcome||PSA progression after 3 years of study treatment|
|- Secondary outcome||1. Quality of life|
2. Performance Status
3. Disease progression
5. Nature and number of Adverse Events
|- Trial web site||http://www.curatrial.com|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| W.J. Bruijn, de|
|- CONTACT for SCIENTIFIC QUERIES||dr. P.F.A. Mulders|
|- Sponsor/Initiator ||University Medical Center St. Radboud, Department of Urology|
(Source(s) of Monetary or Material Support)
|STIWU: Stichting ter bevordering van het Wetenschappelijk Urologisch onderzoek|
|- Brief summary||Patients will be randomised for treatment with either: |
1. Antiandrogen monotherapy: bicalutamide 150 mg taken orally, three tablets of 50 mg bicalutamide daily without interruption or
2. Bicalutamide 150 mg taken orally, three tablets of 50 mg bicalutamide daily plusDutasteride 0.5 mg, 1 capsule, once daily.
It is reasonable to consider that the combination of the 5-alpha-reductase inhibitor, dutasteride, and a pure antiandrogen such as bicalutamide should provide an effective form of maximal androgen blockade (MAB). Dutasteride decreases intraprostatic levels of 5-alpha dihydrotestosterone (DHT), and the antiandrogen would restrain the biological action of the residual DHT by interfering with its association with androgen receptor. This form of MAB should sustain the concentration of testosterone in plasma, thereby maintaining sexual function and reasonable quality of life. In earlier studies with locally advanced prostate cancer patients, finasteride provided additional intraprostatic androgen blockade to flutamide, as measured by additional PSA suppression and a median protocol treatment failure-free survival of 29,9 months, a median castration-free survival of 37 months and an overall survival of 65 % after 5 years. With bicalutamide 150 mg therapy PSA progression is expected in 17-20 % of the patients with locally advanced prostate cancer with 3-4 years of follow up. With the combination finasteride and flutamide therapy PSA progression is expected in 40 % of the patients with locally advanced or M1 prostate cancer with 3 years of follow up.
In order to investigate if the combination of dutasteride and bicalutamide is more effective than bicalutamide therapy alone, this randomized multicenter phase III clinical trial of patients with locally advanced or metastatic cancer of the prostate is proposed.
|- Main changes (audit trail)|
|- RECORD||6-sep-2006 - 4-dec-2006|