Leuprorelin Associated With Radiotherapy Versus Leuprorelin Alone in T3 - T4 or pT3 (on Biopsy) N0, M0 Prostate Cancer

NCT01122121 | Completed Phase 3 DMC

• 2 other identifiers: TAP III/98/032U1111-1169-6728
• Study Type: interventional
• Target: 273
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the efficacy and safety of combined radiotherapy and hormone therapy and hormone therapy alone in the treatment of clinically locally advanced prostate cancer (T3-T4 or pT3 on biopsy, N0, M0).

Conditions

Prostatic Neoplasms, Locally Advanced

Keywords

Drug Therapy; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Progression-free survival at 5 years

  PFS=time from randomization to first documentation of progression (death, biological progression or clinical progression). PFS at Year 5=probability of participants' PFS at Year 5. Biological progression definition I: halfway point between nadir and first rise with prostate-specific antigen (PSA) ≥1 nanogram per milliliter (ng/mL) signifying progression and date of introduction of prostate treatment for all participants, including those leaving prematurely for reason other than progression/death; definition II: first date when PSA=nadir+2 ng/mL and date of introduction of prostate treatment, for participants leaving prematurely for reason other than progression/death. Clinical progression: local clinical progression-\>50% increase in prostate volume relative to lowest volume, recurrence of palpable prostatic tumor after complete regression, positive biopsy; locoregional progression=pelvic regional lymph node lesion development; metastatic progression=distant lesions identification.

  Year 5

Secondary Outcomes (7)

• Time to Biological Progression

  Baseline up to Year 5

• Time to Clinical Progression

  Baseline up to Year 5

• Overall Survival

  Baseline up to Year 5

• Time to Locoregional Progression

  Baseline up to Year 5

• Time to Onset of Metastatic Progression

  Baseline up to Year 5

Study Arms (2)

Combined Radiotherapy and Hormone Therapy

EXPERIMENTAL

Leuprorelin 11.25 milligram (mg) sustained release (SR), injection, subcutaneously, once every 3 months up to 3 years and flutamide 250 mg, tablet, orally, thrice daily for 30 days from the first dose of leuprorelin. Radiotherapy 70 +/- 4 Gray (Gy) in 35 fractions at a rate of 5 fractions of 2 Gy per week up to 3 years. An interval of a maximum of 2 weeks is authorized between radiation of the pelvis with 50 Gy (±4) (5 weeks) and radiation of the prostate with an additional 20 Gy.

Drug: Leuprorelin SR; Radiation: Radiotherapy; Drug: Flutamide

Hormone Therapy alone

ACTIVE COMPARATOR

Leuprorelin 11.25 mg SR, injection, subcutaneously, once every 3 months up to 3 years and flutamide 250 mg, tablet, orally, thrice daily for 30 days from the first dose of leuprorelin.

Drug: Leuprorelin SR; Drug: Flutamide

Interventions

Leuprorelin SR DRUG

Leuprorelin SR injection

Also known as: ENANTONE SR

Combined Radiotherapy and Hormone Therapy; Hormone Therapy alone

Radiotherapy RADIATION

Radiotherapy 70 +/- 4 Gy

Combined Radiotherapy and Hormone Therapy

Flutamide DRUG

Flutamide tablets

Combined Radiotherapy and Hormone Therapy; Hormone Therapy alone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed locally advanced adenocarcinoma of the prostate, graded: T3 or T4 or pT3 on biopsies (presence of tumour tissue in periprostatic fat observed on biopsies), N0 (absence of metastatic), M0 (no distant metastases detectable on the following examinations: bone scan, chest x-ray, abdominal and pelvic ultrasound).
• Patient in whom the prostatic adenocarcinoma has received no prior treatment of any type, with the possible exception of transurethral resection due to obstructive symptoms.
• Patient with a Karnofsky index greater than or equal to (≥) 70.
• Patient aged under 80 years on the randomization date.
• Patient with a life expectancy of at least 7 years.
• Patient who, after having received clear information, gave his written consent to participate and cooperate in the study.
• Patient for whom a recent blood test (less than \[\<\] 2 months) has not revealed elevated transaminases ≥ 3 times the normal laboratory range.

You may not qualify if:

• Patient incapable of understanding the information supplied concerning the study or of giving his consent, or having refused to sign the informed consent form,
• Patient for whom there is a risk that follow-up in compliance with the conditions stipulated by the protocol will not be possible,
• Patient having already received prior treatment for prostate cancer, excluding transurethral resection of the prostate to relieve obstruction,
• Patient having undergone surgical castration, or with a history of bilateral adrenalectomy or hypophysectomy,
• Patient having had another cancer within the previous 5 years (including carcinoma in situ of the bladder) excluding basocellular epithelioma or carcinoma in situ (other than in the bladder),
• Patient with lymph node or metastatic spread of the prostatic adenocarcinoma suspected on imaging,
• Patient with a non-controlled severe active disease,
• Patient with a contraindication to external prostatic radiotherapy,
• Patient with impaired liver function or elevated transaminases ≥3 times the normal laboratory range.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Clinique Mutualiste

Saint-Etienne, 42013, France

Location

Related Publications (1)

• Sargos P, Mottet N, Bellera C, Richaud P. Long-term androgen deprivation, with or without radiotherapy, in locally advanced prostate cancer: updated results from a phase III randomised trial. BJU Int. 2020 Jun;125(6):810-816. doi: 10.1111/bju.14768. Epub 2020 Mar 2.

  PMID: 30946523 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy; Flutamide

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)

Therapeutics; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Nicolas MOTTET, Dr

  Clinique Mutualiste - Saint-Etienne

  PRINCIPAL INVESTIGATOR

• Pierre RICHAUD, Dr

  Institut BERGONIÉ, Centre Régional de Lutte contre le Cancer, Bordeaux

  PRINCIPAL INVESTIGATOR

• Michel PENEAU, Dr

  Martinique

  PRINCIPAL INVESTIGATOR

• Jean-Jacques MAZERON, Pr

  Groupe Hospitalier PITIE-SALPETRIERE, Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2010
• First Posted: May 13, 2010
• Study Start: March 1, 2000
• Primary Completion: December 1, 2008
• Study Completion: June 1, 2009
• Last Updated: July 29, 2015

Record last verified: 2015-07

Locations

FR (1)