Clinical trial NCT02749825: Comparison of Trelstar Versus Lupron or Zoladex in Advanced Prostate Cancer
Official title: A Multicenter, Randomized Clinical Investigation of Trelstar Versus Continued Therapy in Patients Receiving Lupron or Zoladex for Advanced Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Prostate Cancer
Keywords: Prostate
Cancer
Trelstar
Lead sponsor: Pharmatech
Sponsor class: INDUSTRY
Collaborators: name: Manyak, Michael, M.D.
name: Watson Pharmaceuticals
First posted: 2016-04-25
Enrollment: 41
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research study looks at Testosterone levels in patients receiving Trelstar versus those receiving Lupron or Zoladex. These drugs have been approved for treatment of Prostate Cancer by the FDA.

Detailed description: Patients who are currently receiving Lupron or Zoladex will be consented and then randomized to receive either continued treatment with the drug they have been on, or will be randomized to Trelstar for a period of 3 months. At the end of that period, testosterone and prostate serum antigen (PSA) levels will be drawn and compared to their previous levels to determine if Trelstar is as effective as the previous treatment.

Eligibility criteria: Inclusion Criteria:

* Advanced Prostate Cancer
* Currently taking Lupron or Zoladex
* Stable PSA
* Baseline testosterone below castration level
* Life expectancy \> 6 months
* Eastern Cooperative Oncology Group performance status of 0-2
* Signed, approved informed consent.

Exclusion Criteria:

* Known hypersensitivity to any leuteinizing hormone releasing hormone (LHRH) agonist
* Ongoing therapy with hyperprolactinemic agents
* Antiandrogen therapy within 28 days prior to study start
* Prior Orchiectomy, hypophysectomy or adrenalectomy
* Chemotherapy, radiotherapy, or prostatectomy within 28 days prior to study start
* Use of any investigational agent 3 months prior to enrollment
* Use of systemic corticosteroids within 28 days or during study
* Other malignancies within 2 yrs prior to study start, except curatively treated skin cancers
* Severe kidney or liver failure, based on adequate lab values
* Other medical conditions which would be likely to interfere with compliance or completion of study requirements

Primary outcomes:
measure: Maintenance of serum testosterone at or below castration level (50ng/dL)
timeFrame: 12 weeks
Secondary outcomes:
measure: Serum testosterone level at end of study
timeFrame: Week 12
measure: Change in serum testosterone from baseline to end of study
timeFrame: Baseline and week 12
measure: Incidence and severity of adverse events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Urologic Specialists
state: Arizona
city: Hot Springs
country: United States
facility: Heritage Physician Group - Urology Department
state: Arkansas
city: Fresno
country: United States
facility: California Oncology of the Central Valley
state: California
city: San Bernardino
country: United States
facility: San Bernardino Urological Associates Medical Group
state: California
city: Ocala
country: United States
facility: UroSearch
state: Florida
city: Las Vegas
country: United States
facility: Scott A Slavis, MD, PC
state: Nevada
city: Pennsville
country: United States
facility: Shaukat M Qureshi, MD
state: New Jersey
city: Brooklyn
country: United States
facility: Brooklyn Heights Urology Associates
state: New York
city: Brooklyn
country: United States
facility: Jazrawi-Atallah, P.C.
state: New York
city: Albemarle
country: United States
facility: Albemarle Urology Clinic, PA
state: North Carolina
city: Bloomsburg
country: United States
facility: Raj P. Chopra MD, PC
state: Pennsylvania
Study officials:
affiliation: Georege Washington University
name: Michael Michael Manyak, MD
role: PRINCIPAL_INVESTIGATOR
References: