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Trial · Interventional

TerminatedPhase 3Results postedRegistry data

External Beam Radiation Therapy (EBRT) With or Without Hormonal Therapy in Prostate Cancer

NCTNCT00388804 (opens ClinicalTrials.gov in a new tab)Other id2003-0819
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Phase 3
Enrollment
39 participants (actual)
Sponsor
M.D. Anderson Cancer Center · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Feb 2005
Primary completion
Apr 2011
Completion
Apr 2011
First posted
17 Oct 2006 (estimated)
Last update posted
8 Aug 2012 (estimated)
Conditions
Prostate Cancer

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2006200820102012
  1. Ph 3

    External Beam Radiation Therapy (EBRT) With or Without Hormonal Therapy in Prostate Cancer

    NCT00388804

    Feb 2005 to Apr 2011

    Terminated

Registry summary

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

Primary Objective: * To assess the possible improvement in prostate specific antigen (PSA) outcome of short course androgen suppression therapy in conjunction with dose-escalation intensity modulated radiation therapy (IMRT), 3D conformal radiation therapy (3D-CRT), or proton therapy over IMRT, 3D-CRT, or proton therapy alone in prostate cancer patients traditionally considered at intermediate risk for PSA failure following conventional local therapy. PSA failure will be the primary endpoint. Secondary Objectives: * To assess local control, freedom from distant metastasis, and overall survival. * To study the impact of radiation therapy and/or hormone therapy on health-related quality of life measures using the Expanded Prostate Cancer Index Composite-Short Form 12-American Urological Association Symptom Index (EPIC-SF12-AUASI: http://roadrunner.cancer.med.umich.edu/epic/). * To assess prognostic value of pretreatment serum testosterone as well as the decrease in hemoglobin from neoadjuvant hormone therapy. * To assess prognostic value of pretreatment biomarkers on subsequent post-treatment clinical outcomes.

Interventions

  • Radiation TherapyProcedure
  • BicalutamideDrug
  • LeuprolideDrug
  • GoserelinDrug
  • FlutamideDrug
  • QuestionnaireBehavioral

Arms2

  • Active comparator

    RT Group 1

    Radiation Therapy (RT) over 8 1/2 weeks: 42 treatments, 5 days per week with 2 days rest in between.

  • Active comparator

    RT Group 2 + Hormone Therapy

    Radiation Therapy over 8 1/2 weeks; + Hormone Therapy (Bicalutamide 50 mg orally/day or Flutamide 250 mg orally 3 times daily on first 21-30 Days) + Leuprolide (22.5 mg Intramuscularly (IM)/every 3 months or 7.5 mg IM monthly) or Goserelin (10.8 mg subcutaneously every 3 months or 3.6 mg subcutaneously monthly)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Prostate Specific Antigen (PSA) Failures

    Time frame · 3 months up to 2 years

    Registry description

    Baseline + Post-radiation PSA levels at three month intervals for initial two years then every 6 months thereafter. Participants with a rising PSA and no evidence of local or distant recurrence considered PSA failures.

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 outcomeNumber· 3 months up to 2 years

Prostate Specific Antigen (PSA) Failures

GroupValue (participants)
RT Group 10
RT Group 2 + Hormone Therapy0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
RT Group 1Radiation Therapy (RT) over 8 1/2 weeks: 42 treatments, 5 days per week with 2 days rest in between.–0 / 174 / 17
RT Group 2 + Hormone TherapyRadiation Therapy over 8 1/2 weeks; + Hormone Therapy (Bicalutamide 50 mg orally/day or Flutamide 250 mg orally 3 times daily on first 21-30 Days) + Leuprolide (22.5 mg Intramuscularly (IM)/every 3 months or 7.5 mg IM monthly) or Goserelin (10.8 mg subcutaneously every 3 months or 3.6 mg subcutaneously monthly)–0 / 211 / 21

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. Biopsy proven prostate cancer within last 12 months. Pathology must be reviewed at M.D. Anderson Cancer Center (MDACC). 2. 1992 American Joint Committee on Cancer (AJCC) clinical stage T1c-2b on digital rectal exam with biopsy Gleason sum of 7 and Prostate-Specific Antigen (PSA) \< 20 ng/mL (i.e. PSA 19.99 ng/mL or less) 3. 1992 AJCC clinical stage T2b on physical exam with biopsy Gleason sum of 7 or less and/or PSA \< 20 ng/ml 4. 1992 AJCC clinical stage T1c-2b on digital rectal exam with biopsy Gleason sum of 7 or less and PSA \> 10 but less than 20 ng/ml (i.e. 10.01-19.99 ng/mL). PSA used for protocol eligibility should be obtained within 30 days of protocol enrollment. 5. No evidence of metastatic disease on bone scan within 3 months of study enrollment. 6. No evidence of metastatic disease on pelvic computed tomography (CT) or magnetic resonance imaging (MRI) within 3 months of study enrollment. 7. Zubrod performance status \< 2. 8. Must be able to understand protocol and adhere to follow-up initially at 3 months post-radiation and then at 6 month intervals for first two years and annually thereafter. 9. Patient must be able to undergo adequate daily trans-abdominal ultrasound localization (B.A.T.) or other image-guided localization of the prostate during radiation course. 10. Patients will be allowed to participate in other protocols if they are eligible and the other protocols do not interfere with participation in this protocol. Exclusion Criteria: 1. Patients who do not meet the inclusion criteria. Specifically, patients with all the following features: clinical T1c-2a and Gleason sum of 6 and PSA \</= 10 ng/ml. Patients with one or more of the following features: clinical T2c, or Gleason 8-10, or PSA \> 20 ng/ml are not eligible. 2. Prior androgen suppression therapy. (Prior finasteride and saw palmetto allowed but must be discontinued prior to enrollment. Biopsy and PSA must be documented prior to finasteride use.) 3. Previous or concurrent malignancies other than basal or squamous cell skin cancers unless disease-free for 5 years or more. 4. Prior pelvic radiation or chemotherapy. Patients who received chemotherapy for non-prostate cancer malignancies over 5 years prior will be eligible. 5. Prior or planned radical prostate surgery. 6. Patients with clinical evidence or biopsy-proven extracapsular extension, seminal vesicle involvement, or lymph node involvement will be excluded. Patients with radiographic evidence of nodal or bone metastasis will be excluded. 7. Other histologies such as small cell carcinoma, sarcomatoid or ductal variants are not eligible. 8. Patients with any Gleason grade 5 disease on biopsy will not be eligible.

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