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

Primary Purpose

Adenocarcinoma of the Prostate

Status

Unknown status

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

Docetaxel + hormonal treatment (LH-RH agonist)

Hormonal treatment (LH-RH agonist)

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Prostate focused on measuring PSA (biochemical), Progression- free Survival, Clinical progress, Overall survival, Tolerance to the treatment, Quality of Live

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Service Oncologie Médicale, Hopital Europeen Georges Pompidou

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Secondary endpoints were metastasis-free survival, PSA response (decrease > 50 % of the PSA), overall survival, cancer specific survival, safety and quality of life (QoL).

Full Information

NCT ID

NCT00764166

First Posted

September 30, 2008

Last Updated

September 30, 2008

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

ARTIC group (oncologists and urologists association)

1. Study Identification

Unique Protocol Identification Number

NCT00764166

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2008

Overall Recruitment Status

Unknown status

Study Start Date

June 2003 (undefined)

Primary Completion Date

November 2009 (Anticipated)

Study Completion Date

November 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

ARTIC group (oncologists and urologists association)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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). 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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adenocarcinoma of the Prostate

Keywords

PSA (biochemical), Progression- free Survival, Clinical progress, Overall survival, Tolerance to the treatment, Quality of Live

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

254 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Docetaxel + hormonal treatment (LH-RH agonist)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Hormonal treatment (LH-RH agonist)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Time Frame

Every month during 5 years.

Secondary Outcome Measure Information:

Title

Secondary endpoints were metastasis-free survival, PSA response (decrease > 50 % of the PSA), overall survival, cancer specific survival, safety and quality of life (QoL).

Time Frame

Every month during 5 years

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephane Oudard, MD PhD

Organizational Affiliation

European Georges Pompidou Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Service Oncologie Médicale, Hopital Europeen Georges Pompidou

City

Paris

ZIP/Postal Code

75015

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

30703190

Citation

Oudard S, Latorzeff I, Caty A, Miglianico L, Sevin E, Hardy-Bessard AC, Delva R, Rolland F, Mouret L, Priou F, Beuzeboc P, Gravis G, Linassier C, Gomez P, Voog E, Muracciole X, Abraham C, Banu E, Ferrero JM, Ravaud A, Krakowski I, Lagrange JL, Deplanque G, Zylberait D, Bozec L, Houede N, Culine S, Elaidi R. Effect of Adding Docetaxel to Androgen-Deprivation Therapy in Patients With High-Risk Prostate Cancer With Rising Prostate-Specific Antigen Levels After Primary Local Therapy: A Randomized Clinical Trial. JAMA Oncol. 2019 May 1;5(5):623-632. doi: 10.1001/jamaoncol.2018.6607.

Results Reference

derived

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

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