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Prostate CancerPhase 2NCT00100243

Study of Abarelix in Androgen-Independent Prostate Cancer Progressing After Agonist Therapy

A Phase 2 study testing Plenaxis in people with Prostate Cancer, run by PRAECIS Pharmaceuticals Inc. at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase 2, open-label study in subjects with androgen-independent prostate cancer who have progressed following treatment with an LHRH agonist. Up to 22 subjects will be enrolled. 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?
Plenaxis
How many people
22 participants
Where
7 sitesUnited States
Study dates
May 2004to Sep 2005
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

Who may be able to join

  • Signed informed consent
  • Histologically or cytologically confirmed prostate cancer that has progressed within 60 days of the start of screening despite castrate levels of testosterone from treatment with an LHRH agonist. Progression will be defined as one or more of the following: *A rising PSA, defined as at least two consecutive rises in PSA over a reference value (PSA #1). The first rising PSA (PSA #2) must be taken at least one week after PSA #1. A third PSA (PSA #3) is required to be greater than PSA #2; if not, a fourth PSA (PSA #4) is required to be greater than PSA #2, OR
  • The appearance of new metastatic lesions on a bone scan, OR
  • Progression of known lesions or the appearance of new metastatic lesions on CT, MRI, chest x-ray, or other radiographic evaluations.
  • Subject whose hormonal therapy includes an anti-androgen must have the anti-androgen discontinued prior to the start of screening (at least 6 weeks for bicalutamide and at least 4 weeks otherwise). If there is a reduction in the PSA after anti-androgen withdrawal, the subject must continue to demonstrate progression as defined above after anti- androgen withdrawal to be eligible.
  • ECOG Performance Status ≤ 3
Show all 16Show fewer
  • Age ≥ 18 years of age
  • Life expectancy ≥ 6 months
  • Serum testosterone less than or equal to 50 ng/dL
  • PSA ≥ 5 ng/mL (if progression is determined from a rise in PSA)
  • WBC greater than or equal to 3,000/mm3
  • Hematocrit ≥ 30%
  • Platelet count greater than or equal to 100,000/mm3
  • Serum creatinine less than or equal to 2 x upper limit of normal (ULN)
  • Bilirubin (direct or total) less than or equal to 2 x ULN
  • SGPT (ALT) and SGOT (AST) less than or equal to 2 x ULN

Who cannot join

  • A subject is ineligible to participate in the study if he meets any of the following criteria:
  • Prior treatment for prostate cancer with:
  • Chemotherapy
  • Radiopharmaceutical such as strontium or samarium
  • Diethylstilbesterol or another estrogen agonist or antagonist
  • Ketoconazole
Show all 17Show fewer
  • Aminoglutethimide
  • Current treatment with Class IA (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medication
  • Currently taking PC SPES
  • History of allergy to a LHRH agonist or GnRH antagonist
  • Major surgery within 4 weeks
  • Serious medical illnesses, including malnutrition, that in the judgment of the investigator would preclude protocol treatment
  • Significant cardiovascular illness defined as NYHA class III or IV congestive heart failure or unstable angina within 6 months, myocardial infarction within 12 months, deep venous thrombosis within 2 years, or any history of acute pulmonary embolism
  • Active second malignancy other than non-melanoma skin cancer or superficial bladder cancer
  • Any uncontrolled infection, including HIV
  • Any other experimental therapy within 4 weeks prior to study entry
  • QTc > 450 msec on a screening ECG obtained by the investigator

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Columbus Urology Research, LLC

    Columbus, Ohio, 43214

  • Southwest Florida Urological Associates

    Fort Myers, Florida, 33907

  • San Diego Center for Urology

    La Mesa, California, 91942

  • Urological Associates of Lancaster

    Lancaster, Pennsylvania, 17604-3200

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • Panama City Urological Center

    Panama City, Florida, 32405

  • Oregon Health & Science University

    Portland, Oregon, 97201-3098

Other trials in United States

About this study

Official title: Phase 2 Study of Abarelix in Androgen-Independent Prostate Cancer Progressing After Agonist Therapy

This is a Phase 2, open-label study in subjects with androgen-independent prostate cancer who have progressed following treatment with an LHRH agonist. Up to 22 subjects will be enrolled. Enrollment will be monitored to ensure that not all subjects are enrolled based on rising prostate specific antigen (PSA) criterion only.

Subjects will be treated with abarelix (Plenaxis) 100 mg intramuscularly (IM) every 2 weeks for 12 weeks (total dose of 600 mg).

Conditions
Prostate Cancer
Being tested
Plenaxis
Keywords
androgen-independent, 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.

  • PlenaxisDrug

What is being measured

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

  1. Clinical adverse events, laboratory abnormalities, and withdrawals due to adverse events

  2. Serum FSH levels below the lower limit of quantitation (LLOQ) on Days 57 and 85

Timeline

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

  1. First posted28 Dec 2004 (estimated)
  2. Study startMay 2004
  3. Study completionSep 2005

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00100243
Sponsor's protocol ID
149-04-01
Status last verified
Sep 2006
First submitted
27 Dec 2004
Last updated
19 Sep 2006
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Plenaxis in people with Prostate Cancer, run by PRAECIS Pharmaceuticals Inc. at 7 sites 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 17 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: finished, as of the sponsor's last update on 19 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Clinical adverse events, laboratory abnormalities, and withdrawals due to adverse events. The study lists 2 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 NCT00100243.

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 19 Sep 2006.

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