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Prostate CancerPhase 2NCT00244920

Hormone Therapy With or Without Squalamine Lactate in Treating Patients Who Are Undergoing a Radical Prostatectomy for Locally Advanced Prostate Cancer

A Phase 2 study testing bicalutamide, leuprolide acetate and squalamine lactate in people with Prostate Cancer, run by OHSU Knight Cancer Institute.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as leuprolide and bicalutamide, may stop the adrenal glands from making androgens. Squalamine lactate may stop the growth of prostate cancer by blocking blood flow to the tumor. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
bicalutamide, leuprolide acetate and squalamine lactate
Type of treatment
Surgery or procedure
How many people
0 participants
Where
No sites listed yet
Study dates
Jan 2002to Jun 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate
  • Locally advanced disease
  • No metastatic disease
  • High-risk characteristics, meeting ≥ 1 of the following criteria:
  • Large, hard tumor on digital exam
  • Aggressive-appearing cancer cells on biopsy
  • Prostate-specific antigen > 10 ng/mL

PATIENT CHARACTERISTICS:

Performance status

  • 0-1

Life expectancy

  • Not specified

Hematopoietic

  • WBC > 1,500/mm^3
  • Platelet count > 100,000/mm^3
  • Hemoglobin > 11.0 g/dL

Hepatic

  • Bilirubin < 2 times upper limit of normal (ULN)
  • SGOT and SGPT < 2 times ULN
  • PT and PTT normal

Renal

  • Creatinine < 1.8 g/dL

Cardiovascular

  • No history of ventricular arrhythmia or dysfunction
  • No congestive heart failure
  • No symptomatic coronary artery disease
  • No prior myocardial infarction
  • No history of thromboembolic disease (e.g., deep vein thrombosis or stroke) within the past 12 months
  • No other significant cardiovascular disease

Pulmonary

  • No pulmonary embolism within the past 12 months
  • No exercise-limiting respiratory disease

Other

  • Fertile patients must use effective barrier method contraception
  • No sexual intercourse for 6 weeks after surgery
  • No uncontrolled diabetes
  • No serious acute infection
  • No other malignancy except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior squalamine lactate

Chemotherapy

  • No prior chemotherapy for prostate cancer
  • No concurrent anticancer chemotherapy

Endocrine therapy

  • No concurrent systemic corticosteroids

Radiotherapy

  • No prior radiotherapy for prostate cancer
  • No concurrent radiotherapy

Surgery

  • No prior surgery for prostate cancer
  • No other concurrent surgery

Other

  • At least 6 weeks since prior and no concurrent use of over-the-counter or herbal drugs that have estrogenic activity
  • No participation in another investigational study within the past 3 months
  • No concurrent participation in another investigational study

About this study

Official title: An Open Label Randomized Phase 2 Study To Evaluate The Activity, Tolerability, And Toxicity Of Combined Neoadjuvant Anti-angiogenesis and Androgen Ablation Therapy in Men Undergoing Radical Prostatectomy

RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as leuprolide and bicalutamide, may stop the adrenal glands from making androgens. Squalamine lactate may stop the growth of prostate cancer by blocking blood flow to the tumor. Giving hormone therapy together with squalamine lactate before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This randomized phase II trial is studying how well giving hormone therapy together with squalamine lactate works compared to hormone therapy alone in treating patients who are undergoing a radical prostatectomy for locally advanced prostate cancer.

Read the detailed description

OBJECTIVES:

  • Compare the effect of neoadjuvant androgen-ablation therapy with vs without squalamine lactate on induced tumor regression and grade migration in patients with locally advanced high-risk adenocarcinoma of the prostate undergoing a radical prostatectomy.
  • Compare the duration of clinical disease-free survival of patients treated with these regimens.
  • Determine the applicability of prostate-specific antigen (PSA) serology as an endpoint determinant in patients treated with these regimens.
  • Compare the feasibility and potential safety effects on wound healing and recovery in patients treated with these regimens before and after a radical prostatectomy.

OUTLINE: This is an open-label, randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive leuprolide intramuscularly once a month for 3 months and oral bicalutamide once a day for 2 weeks.
  • Arm II: Patients receive leuprolide and bicalutamide as in arm I plus squalamine lactate IV over 4 hours once weekly for 6 weeks.

Seven weeks after beginning treatment, patients in both arms undergo standard radical prostatectomy. Patients then continue to receive leuprolide and bicalutamide with or without squalamine lactate for up to 6 additional weeks.

After completion of study treatment, patients are followed periodically for at least 3 years.

PROJECTED ACCRUAL: A total of 132 patients (66 per treatment arm) will be accrued for this study.

Conditions
Prostate Cancer
Being tested
bicalutamide, leuprolide acetate, squalamine lactate, adjuvant therapy, antiandrogen therapy
Keywords
adenocarcinoma of the prostate, stage III prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bicalutamideDrug

  • leuprolide acetateDrug

  • squalamine lactateDrug

  • adjuvant therapyProcedure or surgery

  • antiandrogen therapyProcedure or surgery

  • antiangiogenesis therapyProcedure or surgery

  • conventional surgeryProcedure or surgery

  • neoadjuvant therapyProcedure or surgery

  • releasing hormone agonist therapyProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tumor response in terms of tumor volume as measured by transrectal ultrasound before and after neoadjuvant treatment

  2. Tumor response in terms of conventional histopathology as measured by prostatectomy specimens and Gleason scores in comparison to pre-treatment biopsies

  3. Tumor response in terms of molecular markers as measured by changes in VEGF, VEGF-flt-1, and integrin Alpha6Beta4, AlphaVBeta3, and AlphaVBeta5 expression in pre-treatment biopsy and post-treatment prostatectomy specimens

Secondary outcomes (3)

  1. Safety, feasibility, and tolerability as measured by CTCAE v3.0

  2. Prostate-specific antigen (PSA) serology as measured by PSA value during and after completion of study treatment

  3. Survival for up to 3 years after completion of study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2005 (estimated)
  2. Study startJan 2002
  3. Primary completionJun 2007
  4. Study completionJun 2007

Why it stopped: Sponsor withdrew drug.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00244920
Sponsor's protocol ID
CDR0000446087
Other IDs
OHSU-MSI-1256F-204, OHSU-IRB-357
Status last verified
May 2011
First submitted
25 Oct 2005
Last updated
28 May 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bicalutamide, leuprolide acetate and squalamine lactate in people with Prostate Cancer, run by OHSU Knight Cancer Institute.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 28 May 2012. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tumor response in terms of tumor volume as measured by transrectal ultrasound before and after neoadjuvant treatment. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00244920.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2012.

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