Adenocarcinoma of the ProstatePhase 2NCT01054079
Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer
A Phase 2 study testing laboratory biomarker analysis, quality-of-life assessment and questionnaire administration in people with Adenocarcinoma of the Prostate and Recurrent Prostate Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This phase II trial is studying how well cinacalcet hydrochloride works in treating men with recurrent prostate cancer. Cinacalcet hydrochloride may be effective in lowering prostate-specific antigen (PSA) levels in patients with recurrent prostate cancer that has not responded to previous treatment Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Adenocarcinoma of the Prostate, Recurrent Prostate Cancer
- What is being tested?
- laboratory biomarker analysis, quality-of-life assessment and questionnaire administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Aug 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 or cytologically confirmed adenocarcinoma of the prostate
- For patients who have recurrent disease following surgery as first line therapy ("surgical failures")
- PSA requirement is 0.2 ng/ml or above
- For patients who have recurrent disease following radiation as first line therapy, the eligibility follows the "Phoenix criteria", that is, a rise of 2 ng/mL over the PSA nadir
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- Granulocytes >= 1000/uL
Show all 13Show fewer
- Serum creatinine =< 2.0 mg/dl
- Total serum calcium > 9.0 and < 10.5 mg/dl
- Total bilirubin =< 2.0 mg/dl
- Platelet count >=100,000/uL
- Hemoglobin (Hgb) >= 9 g/dL
- Total testosterone >= 50 ng/dL
- Ability to understand and the willingness to sign a written informed consent document (either directly or via a legally authorized representative)
Who cannot join
- Serious medical illness which would limit survival to less than 3 months
- Active, uncontrolled bacterial, viral or fungal infection
- Hemorrhagic disorder
- Any radiographic evidence of metastatic disease including positive bone scan or computed tomography (CT) abdomen/pelvis
- History of hypocalcemia or seizure disorder
- Patients with known hypersensitivity to any of the components of cinacalcet (cinacalcet hydrochloride)
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: A Phase II Trial to Assess the Effect of Cinacalcet Hydrochloride on PSA Levels in Patients With Biochemically Recurrent Prostate Cancer After Failed Definitive Local Therapy
This phase II trial is studying how well cinacalcet hydrochloride works in treating men with recurrent prostate cancer. Cinacalcet hydrochloride may be effective in lowering prostate-specific antigen (PSA) levels in patients with recurrent prostate cancer that has not responded to previous treatment
Read the detailed description
PRIMARY OBJECTIVES:
- To test the hypothesis that once-daily treatment with 30 mg of cinacalcet hydrochloride (Sensipar) will reduce the rate of rise of serum prostate-specific antigen (PSA) compared to pre-treatment PSA values in subjects with biochemically recurrent prostate cancer after failed definitive local therapy.
OUTLINE:
Patients receive cinacalcet hydrochloride orally (PO) once daily (QD) for 20 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 4 weeks.
- Being tested
- laboratory biomarker analysis, quality-of-life assessment, questionnaire administration, cinacalcet hydrochloride
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisOther
Correlative study
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary study
questionnaire administrationOther
Ancillary study
cinacalcet hydrochlorideDrug
Also called Mimpara, Sensipar
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Treatment (cinacalcet hydrochloride) | Experimental | Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity. Receives: Other: laboratory biomarker analysis; Procedure: quality-of-life assessment; Other: questionnaire administration; Drug: cinacalcet hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Rise of Serum PSA
The difference of post treatment and pre-enrollment PSA.For those with multiple PSA measures post we use the median of those measures to estimate the participant's post PSA level.
Measured: 24 weeks
Secondary outcomes (4)
Change in Quality of Life (QOL) as Assessed by the Brief Male Sexual Inventory
The Brief Male Sexual Inventory is an 11 question assessment including subscales: sex drive, erections, ejaculation. The scores are totaled to produce an overall score with a range of 1-45, with higher score indicating worse outcomes.
Measured: Up to 20 weeks
Change in Hormonal Assessment Scale From Expanded Prostate Cancer Index Composite (EPIC)
The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Epic produces two scores, one for function (5 items) and the other for bother (6 items). The response for each item is standardized to a 0 to 100 scale. For both scales, higher scores indicate worse outcomes.
Measured: up to 20 weeks
Change in Functional Assessment of Cancer Therapy-Prostate (FACT-P)
The FACT-P is a multidimensional, self-report QoL instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce subscale scores for each domain, as well as a global QoL score. All subscale items are summed to a total. The score range is 0-156. Higher scores represent better quality of life.
Measured: up to 20 weeks
Change in Total and Free Testosterone
The detectable difference is estimated using a paired t-test approach. The lab measure will also be analyzed longitudinally using all measures with a mixed model approach adjusting for individual covariates.
Measured: Up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2010 (estimated)
- Study startSep 2011
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adenocarcinoma of the ProstateStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- K.C. Balaji, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01054079
- Sponsor's protocol ID
- IRB00009741
- Other IDs
- NCI-2009-01514, CCCWFU 98309
- Status last verified
- Jul 2018
- First submitted
- 21 Jan 2010
- Last updated
- 5 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial to Assess the Effect of Cinacalcet Hydrochloride on PSA Levels in Patients With Biochemically Recurrent Prostate Cancer After Failed Definitive Local Therapy
- ClinicalTrials.gov ID
- NCT01054079
- Acronym / sponsor ID
- IRB00009741
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 22 Jan 2010 (estimated)
- Results
- Posted 29 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial is studying how well cinacalcet hydrochloride works in treating men with recurrent prostate cancer. Cinacalcet hydrochloride may be effective in lowering prostate-specific antigen (PSA) levels in patients with recurrent prostate cancer that has not responded to previous treatment
Detailed description
PRIMARY OBJECTIVES:
- To test the hypothesis that once-daily treatment with 30 mg of cinacalcet hydrochloride (Sensipar) will reduce the rate of rise of serum prostate-specific antigen (PSA) compared to pre-treatment PSA values in subjects with biochemically recurrent prostate cancer after failed definitive local therapy.
OUTLINE:
Patients receive cinacalcet hydrochloride orally (PO) once daily (QD) for 20 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (cinacalcet hydrochloride) | Experimental | Other: laboratory biomarker analysis, Procedure: quality-of-life assessment, Other: questionnaire administration, Drug: cinacalcet hydrochloridePatients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients must have histologically or cytologically confirmed adenocarcinoma of the prostate
- For patients who have recurrent disease following surgery as first line therapy ("surgical failures")
- PSA requirement is 0.2 ng/ml or above
- For patients who have recurrent disease following radiation as first line therapy, the eligibility follows the "Phoenix criteria", that is, a rise of 2 ng/mL over the PSA nadir
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Key exclusion criteria (6 listed)
- Serious medical illness which would limit survival to less than 3 months
- Active, uncontrolled bacterial, viral or fungal infection
- Hemorrhagic disorder
- Any radiographic evidence of metastatic disease including positive bone scan or computed tomography (CT) abdomen/pelvis
- History of hypocalcemia or seizure disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laboratory biomarker analysisCorrelative study | Other | Treatment (cinacalcet hydrochloride) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary study | Procedure or surgery | Treatment (cinacalcet hydrochloride) |
| questionnaire administrationAncillary study | Other | Treatment (cinacalcet hydrochloride) |
| cinacalcet hydrochlorideAlso: Mimpara, SensiparGiven PO | Drug | Treatment (cinacalcet hydrochloride) |
Primary outcome
Rate of Rise of Serum PSA
Time frame: 24 weeks
The difference of post treatment and pre-enrollment PSA.For those with multiple PSA measures post we use the median of those measures to estimate the participant's post PSA level.
4 secondary outcomes
Change in Quality of Life (QOL) as Assessed by the Brief Male Sexual Inventory
Time frame: Up to 20 weeks
Change in Hormonal Assessment Scale From Expanded Prostate Cancer Index Composite (EPIC)
Time frame: up to 20 weeks
Change in Functional Assessment of Cancer Therapy-Prostate (FACT-P)
Time frame: up to 20 weeks
Change in Total and Free Testosterone
Time frame: Up to 20 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Adenocarcinoma of the Prostate
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingPhase 1
Hypofractionated Accelerated Pelvic Nodal Radiotherapy (GCC 2048)
Prostate Cancer, Prostate Adenocarcinoma
Not yet recruitingPhase 2
Testing the Anti-cancer Drug DSP-5336 (Enzomenib) in Prostate Cancer
Metastatic Castration-Resistant Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
K.C. Balaji, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing laboratory biomarker analysis, quality-of-life assessment and questionnaire administration in people with Adenocarcinoma of the Prostate and Recurrent Prostate Cancer, run by Wake Forest University Health Sciences 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 13 inclusion and 6 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 5 Jul 2018. 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.
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?
Yes. Results are posted in the registry (first posted 29 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Rate of Rise of Serum PSA (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jul 2018.