Trial · Interventional

TerminatedPhase 3Results postedRegistry data

Randomized Trial of Adjuvant Hormonal Therapy in Surgically Treated Prostate Cancer Patients at High Risk for Recurrence

NCTNCT00003645Other idID97-077Other idP30CA016672Other idMDA-ID-97077Other idE-97077

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: Per PI request

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 3
Enrollment: 64 participants (actual)
Sponsor: M.D. Anderson Cancer Center · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: 14 Jun 1999
Primary completion: 20 Mar 2017
Completion: 20 Mar 2017
First posted: 15 Jul 2003 (estimated)
Last update posted: 28 Apr 2020
Conditions: Prostate Cancer

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2000200520102015

Ph 3
Randomized Trial of Adjuvant Hormonal Therapy in Surgically Treated Prostate Cancer Patients at High Risk for Recurrence
NCT00003645
14 Jun 1999 to 20 Mar 2017
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

RATIONALE: Testosterone can stimulate the growth of prostate cancer cells. Hormone therapy using leuprolide and flutamide may fight prostate cancer by reducing the production of testosterone. It is not yet known whether receiving leuprolide and flutamide is more effective than receiving no further therapy. PURPOSE: Randomized phase III trial to determine the effectiveness of hormone therapy in treating patients who have stage I or stage II prostate cancer that is at high risk of recurrence and who have already undergone surgery.

Interventions

FlutamideDrug
Leuprolide AcetateDrug

Arms2

Experimental
Arm I - Leuprolide + Flutamide
Arm I: Patients receive leuprolide intramuscularly once every 3 months and oral flutamide three times daily for 1 year.
No intervention
Arm II - No Treatment
Arm II: Patients receive no initial treatment.

Primary outcomes1

Outcomes the sponsor listed as primary.

Number of Participants With Disease Free Survival at 5 Years
Time frame · Beginning of the study up to 5 years
Registry description
To determine if one year of adjuvant hormonal ablation in node negative radical prostatectomy patients at high risk for progression will result in an improvement in disease-free survival at five years.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcome· Beginning of the study up to 5 years

Number of Participants With Disease Free Survival at 5 Years

Group	Value
Arm I - Leuprolide + Flutamide	not posted
Arm II - No Treatment	not posted

Secondary and other outcome results(3)

Other pre specified outcomeCount of participants· 2 years

Number of Wives of the Participants Having Better Than or Equal to a "Good" Quality of Life

Group	Value (Participants)
Arm A	19
Arm B	24

Other pre specified outcomeMean· 1 year

Quality of Life for Participants

Group	Value (score on a scale)
Arm I - Leuprolide + Flutamide	55
Arm II - No Treatment	54

Other pre specified outcome· 1 year after treatment

Markers of Prognosis

Group	Value
Arm I - Leuprolide + Flutamide	not posted
Arm II - No Treatment	not posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Arm I - Leuprolide + FlutamideArm I: Patients receive leuprolide intramuscularly once every 3 months and oral flutamide three times daily for 1 year. Flutamide: 10.8 mg intramuscularly once every 3 months for 12 months Leuprolide Acetate: 50 mg tablet orally daily for 12 months	4 / 30	6 / 30	25 / 30
Arm II - No TreatmentArm II: Patients receive no initial treatment.	1 / 34	0 / 0	0 / 0

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Male
Age: Not stated
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: 1. Organ confined prostate cancer (stage T1-T2c) subsequent to clinical staging 2. Radical prostatectomy and bilateral lymph node dissection performed 3. Pathologic assessment of surgical specimens by MDACC pathologist 4. High risk of clinical or biochemical failure post prostatectomy (must fulfill one of the following criteria): pathology; a) Gleason grade sum score greater than or equal to 8, b) Seminal vesicle involvement, c) Extraprostatic extension with positive surgical margins and Gleason greater than or equal to 7 5. Radical prostatectomy performed within 90 days of enrollment and serum PSA level \< 0.1ng/ml 6. Written informed consent Exclusion Criteria: 1. Any evidence of metastatic disease confirmed prior to enrollment 2. Inability to confirm pathologic risk factors or inadequate prostatectomy (see item 4.1.5). 3. Hormonal ablation for greater than 3 months or radiotherapy for prostate cancer 4. Failure to achieve prostate specific antigen level of less than 0.1ng/ml prior to enrollment in study 5. Elevation of liver function tests 2x normal 6. Contraindication to the use of LH-RH agonists or antiandrogens 7. Active secondary malignancy (other than squamous or basal cell skin cancer) within five years prior to enrollment in study 8. Any concomitant medical condition that would make it undesirable for the 7patient to participate in the trial or jeopardize compliance with the protocol

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