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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy

NCTNCT00776594 (opens ClinicalTrials.gov in a new tab)Other id08-190
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names Goserelin, does not test it. It appears in the summary.
  • Names Leuprolide, does not test it. It appears in the summary.

Overview

Status
Completed
Phase
Phase 2
Enrollment
102 participants (actual)
Sponsor
Dana-Farber Cancer Institute · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Oct 2008
Primary completion
Dec 2014
Completion
Sept 2016
First posted
21 Oct 2008 (estimated)
Last update posted
21 Oct 2016 (estimated)
Conditions
Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20082010201220142016
  1. Ph 2

    Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy

    NCT00776594

    Oct 2008 to Sept 2016

Registry summary

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

The purpose of this research study is to assess the efficacy of antiangiogenic therapy (bevacizumab) and androgen deprivation versus androgen deprivation alone at the time of minimal systemic disease (based on rising PSA without metastases).

Interventions

  • Androgen Deprivation TherapyDrug
  • bicalutamideDrug
  • bevacizumabDrug

Arms2

  • Experimental

    Group 1

    Androgen Deprivation Therapy Plus Bevacizumab

  • Experimental

    Group 2

    Androgen Deprivation Therapy Alone

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Relapse-free Survival

    Time frame · 2 years

    Registry description

    To identify a difference in relapse-free survival in men treated with short course ADT (6 months) versus short course ADT plus bevacizumab.

Secondary outcomes(3)

  1. Number of Participants With PSA <0.2 ng/ml at Six Months

    Time frame · Six months (at completion of treatment)

    Registry description

    Number of participants with a PSA \<0.2 ng/ml at six months (upon completion of treatment).

  2. Cardiovascular Safety Including Measurement of Blood Pressure During Treatment Period (6 Months).

    Time frame · 6 months

    Registry description

    The number of patients who developed hypertension (greater that 150 systolic or greater than 90 diastolic) during treatment period.

  3. Analysis of Cytokines and Angiogenic Factors in Plasma/Serum

    Time frame · 6 months

    Registry description

    Analysis of cytokines and angiogenic factors in plasma/serum at baseline and at 6 months (end of treatment).

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 outcomeMedian· 2 years

Relapse-free Survival

GroupValue (months)
Group 113
Group 210
Secondary and other outcome results(3)
Secondary outcomeNumber· Six months (at completion of treatment)

Number of Participants With PSA <0.2 ng/ml at Six Months

GroupValue (Number of participants)
Group 151
Group 227
Secondary outcomeNumber· 6 months

Cardiovascular Safety Including Measurement of Blood Pressure During Treatment Period (6 Months).

GroupValue (participants)
Group 148
Group 213
Secondary outcomeMedian· 6 months

Analysis of Cytokines and Angiogenic Factors in Plasma/Serum

GroupValue (pg/ml)
Leptin Level in Patients Treated With ADT+Bev13755
Leptin in Patients Treated With ADT Alone10179

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Group 2Androgen Deprivation Therapy Alone Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months bicalutamide: 50mg orally daily for 6 months–5 / 3632 / 36
Group 1Androgen Deprivation Therapy Plus Bevacizumab Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months bicalutamide: 50mg orally daily for 6 months bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months–18 / 6663 / 66

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
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * History of biopsy documented prostate cancer (any Gleason score) * Past treatment with prostatectomy with or without salvage prostate/pelvic radiation or primary radiation (external beam or brachytherapy) * If past prostatectomy, pathologic stage no greater than T1-3, N1, M0 * PSA recurrence with PSAdt \< 18 months. There is no minimum PSA for prostatectomy patients. For patients treated with primary radiation therapy PSA should be greater than 2.0 ng/ml * No evidence of recurrent disease on exam, bone scan, CT/MRI abdomen/pelvis or CXR * Prior ADT allowed if \< 6 months and testosterone recovered to within 50 units (ng/dl) of normal range * ECOG Performance status of 0-1 * Absolute neutrophil count of \>1,500 * Platelet count \> 100,000 * Hg \> 8g/dl * No history of bleeding or thromboses within the last 12 months that required medical intervention Exclusion Criteria: * History of cancer within 5 years, other than prostate cancer and non-melanoma skin cancer * Medical condition requiring concomitant corticosteroids * Active infection * Prior chemotherapy allowed if was \< 6 cycles and \> 6 months prior to study entry * Documented local recurrence or metastatic prostate cancer * Inability to comply with study and/or follow-up procedures * Life expectancy of less than 2 years * Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study

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