A Prospective Randomized Phase III Study Comparing Hormonal Therapy +/-Docetaxel

Adenocarcinoma of the Prostate Clinical Trial

— RisingPSA  

Official title:

Non-Metastatic High-Risk Prostate Cancer Patients With Biochemical Relapse Only After Local Treatment. A Prospective Randomized Phase III Study Comparing Hormonal Therapy +/-Docetaxel

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00764166
• Other study ID #: AOM 03108
• Status: Active, not recruiting
• Phase: Phase 3
• First received: September 30, 2008
• Last updated: September 30, 2008
• Start date: June 2003
• Est. completion date: November 2010

Study information

• Verified date: September 2008
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The primary objective was to evaluate the PSA (biochemical) progression-free survival (PFS) of high-risk metastasis-free PC patients, treated with LH-RH agonist for one year with or without docetaxel after prior radical prostatectomy (RP) or radiotherapy (RT).

The study was powered at 80% to detect a 25% improvement in biochemical PFS for a total sample size estimated at 252 patients, with a two-sided type I error rate of 5% (non-parametric methods.

Description:

Docetaxel was shown to be active in metastatic hormone-refractory prostate cancer (PC) in phase III trials (1-2). It is likely to demonstrate a substantial role in the management of early-stage PC patients in the neoadjuvant and adjuvant settings, where clinical trials are underway.•53% of all men who undergo radical prostatectomy will develop prostate-specific antigen (PSA) elevations in the 10 years following surgery, with approximately 77% of these recurrences occurring within the first 2 years.A prospective, multicenter, national, randomized, two-arm, phase III study comparing hormonal treatment (LH-RH agonist alone) with or without docetaxel was designed to evaluate the interest of chemotherapy in non-metastatic prostate cancer patients at high risk of systemic recurrence after initial treatment (radical prostatectomy or radiotherapy).

1. PETRYLAK DP, et al: Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med 351:1513-1520, 2004

2. TANNOCK IF, de Wit R, Berry WR, et al: Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 351:1502-1512, 2004

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 254
• Est. completion date: November 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically documented adenocarcinoma of the prostate

• Previous treatment with either radical prostatectomy or radiation therapy

• Salvage radiotherapy for local relapse allowed

• Neoadjuvant or per radiotherapy Hormonal therapy allowed in case of more than 6 months free-interval before first rising PSA

• Life expectancy of more than 12 months

• Non metastatic disease documented by imaging including radionuclide bone scan

• ECOG performance status 0-1

• ANC > 1,500/mm3

• Platelet counts > 100,000/mm3

• SGOT and/or SGPT may be up to 2.5 x ULN

Patients at high risk of biological relapse defined by:

• Gleason > 8

• PSA-DT < 6 months

• Positive surgical margins

• PSA velocity > 0.75 ng/mL/year

• Pathological pelvic lymph nodes involvement (pN+)

• Time from initial treatment until inclusion < 12 months

Exclusion Criteria:

• Prior chemotherapy by taxanes and estramustine phosphate

• Documented local recurrence of prostate cancer or documented metastatic disease

• History of other malignancy within the last 5 years other than curatively treated basal cell carcinoma of the skin

• Active infection

• Significant cardiac disease, angina pectoris or myocardial infarction within twelve months

• Clinically significant neuropathy

• Medical condition requiring the use of concomitant corticosteroids

• Prohibited concomitant therapy with experimental drug.

• Participation in another clinical trial for the period < 30 days

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Prostate
• Prostatic Neoplasms

Intervention

Drug:
• Docetaxel + hormonal treatment (LH-RH agonist)
Docetaxel will be administered: To D1 of every cycle in the dose of 70 mg/m², Perfusion IV of 60 minutes diluted in 250 ml with physiological serum or with serum glucoside from a peripheral or central vein, Every 3 weeks during 6 cycles (except when unacceptable tolerance). Triptorelin was given by injection for 4 times every 3 months Bicalutamide was given at the same time with LH-RH agonist for 3 weeks ; taken orally
• Hormonal treatment (LH-RH agonist)
Triptorelin was given by injection for 4 times every 3 months. Bicalutamide given at the same time with LH-RH agonist for 3 weeks ; taken orally.

Locations

Country	Name	City	State
France	Service Oncologie Médicale, Hopital Europeen Georges Pompidou	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	ARTIC group (oncologists and urologists association)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint was the PSA (biochemical) progression-free survival (PFS) of high-risk metastasis-free PC patients, treated with LH-RH agonist for one year with or without docetaxel after prior radical prostatectomy (RP) or radiotherapy (RT).		Every month during 5 years.	Yes
Secondary	Secondary endpoints were metastasis-free survival, PSA response (decrease > 50 % of the PSA), overall survival, cancer specific survival, safety and quality of life (QoL).		Every month during 5 years	No