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Prostate CancerHITNCT01007214

Guided Biopsy for Mapping Prostate Cancer

A study testing Prostatectomy in people with Prostate Cancer, run by Roswell Park Cancer Institute at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Evaluate the accuracy of HIT guided biopsies for mapping tumor foci with men undergoing prostatectomy. 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?
Prostatectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteUnited States
Study dates
May 2010to Feb 2014
Phase
Interventional
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

Who may be able to join

  • Patients must have histologically confirmed diagnosis of prostate cancer
  • Patients must have elected to undergo radical prostatectomy using an open, laparoscopic or robotic approach
  • Patients must be at least 18 years of age and able to provide written informed consent.
  • No history of radiotherapy, chemotherapy or hormone therapy within 6 months of surgery
  • Primary tumor must be amenable to surgical removal for curative intent
  • Patients must have ECOG-performance status 0 or 1 (appendix II)
Show all 16Show fewer
  • Patients must have no history of rectal or anal disease.
  • Patients must have adequate organ function as defined by the following criteria:
  • Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT])≤2.5x local laboratory upper limit of normal (ULN), or AST and ALT ≤5x ULN if liver function abnormalities are due to underlying malignancy
  • Total serum bilirubin ≤1.5 x ULN
  • Absolute neutrophil count(ANC)≥1,500/microL
  • Platelets≥lOO,OOO/microL
  • Hemoglobin≥9.0 g/dL
  • Serum calcium≤10.2mg/dL (correct for low albumin if necessary; calcium + (normal albumin - serum albumin)x 0.8)
  • Patients must have serum creatinine<2 mg/dL or serum creatinine clearance (CrCl)>40ml/min(CrCl= Wt(kg)x(140-age)*/72xCr. level,*female x 0.85)
  • Members of all races and ethnic groups are eligible for this trial. Women and children are not eligible since prostate cancer is not diagnosed in these groups.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Roswell Park Cancer Institute

    Buffalo, New York, 14141

Other trials in United States

About this study

Official title: Hybrid Imaging Technique (HIT) Guided Biopsy to Map Prostatic Adenocarcinoma in Patients Undergoing Prostatectomy

Evaluate the accuracy of HIT guided biopsies for mapping tumor foci with men undergoing prostatectomy.

Read the detailed description

The objective of this study is to determine the accuracy of HIT (Hybrid Imaging Technology) guided biopsies for mapping tumor foci with men undergoing prostatectomy. Using a prostate hybrid imaging technology (HIT) which fuses a previously obtained endorectal MR image to transrectal ultrasound (TRUS) image to allow identification and biopsy of tumors by MR imaging in real time. We hypothesis that HIT guided biopsies will accurately localize the foci of prostate cancer.

Conditions
Prostate Cancer
Being tested
Prostatectomy
Keywords
Prostate cancer, Prostatectomy
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • ProstatectomyProcedure or surgery

    Also called Prostate cancer

    Elective prostatectomy

Study groups in NCT01007214
Study groupRoleWhat they receive
Prostate cancerExperimentalA total of 30 patients diagnosed with prostate cancer who have elected to undergo radical prostatectomy are enrolled over a six year period.
Receives: Procedure: Prostatectomy

What is being measured

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

  1. Determine the accuracy of hybrid image technology (HIT) guided biopsies for prostate cancer mapping.

    Measured: Six years

Timeline

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

  1. First posted3 Nov 2009 (estimated)
  2. Study startMay 2010
  3. Primary completionFeb 2014
  4. Study completionFeb 2014

Why it stopped: Not able to meet accrual

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 N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01007214
Sponsor's protocol ID
I 133608
Acronym
HIT
Status last verified
Feb 2014
First submitted
29 Oct 2009
Last updated
27 Feb 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Prostatectomy in people with Prostate Cancer, run by Roswell Park Cancer Institute at 1 site in United States.

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

Who may be eligible to take part?

The sponsor lists 16 inclusion and 0 exclusion criteria. 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: stopped early, as of the sponsor's last update on 27 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

Are results available for this study?

The study was stopped early (reason given: Not able to meet accrual). Results are not available in the source record.

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?

Determine the accuracy of hybrid image technology (HIT) guided biopsies for prostate cancer mapping. (time frame: Six years). 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 NCT01007214.

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 27 Feb 2014.

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