Hormone-Resistant Prostate CancerPhase 2NCT01253642
Phenelzine Sulfate and Docetaxel in Treating Patients With Prostate Cancer With Progressive Disease After First-Line Therapy With Docetaxel
A Phase 2 study testing Biopsy of Prostate, Docetaxel and Laboratory Biomarker Analysis in people with Hormone-Resistant Prostate Cancer and Metastatic Prostatic Adenocarcinoma, run by OHSU Knight Cancer Institute at 3 sites in United States.
Trial summary
This phase II trial studies how well giving phenelzine sulfate together with docetaxel works in treating patients with prostate cancer that is growing, spreading, or getting worse after first-line therapy with docetaxel. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hormone-Resistant Prostate Cancer, Metastatic Prostatic Adenocarcinoma, Prostate Adenocarcinoma
- What is being tested?
- Biopsy of Prostate, Docetaxel and Laboratory Biomarker Analysis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 Jul 2010to 15 Sep 2017
- 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
- Histological or cytological diagnosis of adenocarcinoma of the prostate
- Radiographic evidence of regional or distant metastases with suspected tumor in an area that is safe to biopsy
- Willingness to undergo tumor biopsy
- Evidence of CRPC indicated by history of progression despite standard hormonal therapy (by PSA and/or imaging studies)
- Planned or recent initiation of standard docetaxel therapy; patients may be enrolled after receiving standard docetaxel therapy as long as the patient has not demonstrated evidence of progression for more than 45 days before enrollment ("late enrollers")
- For patients who have been on anti-androgen therapy and had evidence of response to the addition of an anti-androgen (i.e., PSA reduction), patients must have discontinued anti-androgen therapy for at least six weeks (4 weeks for flutamide) without current evidence of an anti-androgen withdrawal response
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- Serum testosterone levels < 50 ng/dL (unless surgically castrate); patients must continue androgen deprivation with an luteinizing hormone releasing hormone (LHRH) agonist if they have not undergone orchiectomy
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- Has recovered from all therapy-related toxicity to =< grade 2 (except alopecia, anemia and any signs or symptoms of androgen deprivation therapy)
- Absolute neutrophil count >= 1500/uL
- Platelets >= 100,000
- Creatinine =< 1.5 times upper limit of normal (ULN)
- Bilirubin =< 1.5 times ULN (if total bilirubin elevated, but direct is within normal limits [WNL], patient is eligible)
- Alanine aminotransferase (ALT) =< 2.5 times ULN
- PSA > 2 ng/mL (at the time of enrollment or prior to initiation of docetaxel)
- Life expectancy > 3 months
- Signed informed consent
Who cannot join
- Significant peripheral neuropathy defined as grade 2 or higher
- A second active malignancy except adequately treated non-melanoma skin cancer or other non-invasive or in situ neoplasm
- Significant active concurrent medical illness or infection precluding protocol treatment or survival
- Current uncontrolled hyperthyroidism
- Pheochromocytoma
- Carcinoid Syndrome
Show all 11Show fewer
- Known or suspected brain metastases
- Treatment with radiotherapy within the past 4 weeks or radiopharmaceutical therapy (strontium, samarium) within the past 8 weeks
- Concurrent therapy with a Selective Serotonin Reuptake Inhibitor (SSRI), tricyclic antidepressant, or Monoamine Oxidase Inhibitor (MAOi); clinical judgment should be used in a decision to discontinue antidepressants; a minimum of a 1 week washout period is required for any tricyclic or related antidepressant, or any SSRI (2 weeks for paroxetine or sertraline, 5 weeks for fluoxetine); minimum 2 week washout for any MAOi
- Concurrent therapy with any excluded medications that cannot be safely discontinued prior to initiation of combination therapy; discontinuation prior to enrollment is not required, but discontinuation prior to combination therapy must be possible
- Caution should be exercised in patients who are regularly taking narcotic analgesics, particularly higher doses; the doses of narcotic analgesics may need to be reduced, patients may need to be monitored closely for drug interactions, and the risks and benefits of participation in the study should be considered; clinical judgment should be exercised to manage this potential drug interaction
Trial locations and contacts
3 sites in 1 country.
United States3 sites
OHSU Knight Cancer Institute
Portland, Oregon, 97239
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Seattle Cancer Care Alliance
Seattle, Washington, 98109
About this study
Official title: A Phase II Study of MAOA Inhibitor Plus Docetaxel in Patients Receiving and Progressing on Docetaxel Therapy
This phase II trial studies how well giving phenelzine sulfate together with docetaxel works in treating patients with prostate cancer that is growing, spreading, or getting worse after first-line therapy with docetaxel. Phenelzine sulfate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Phenelzine sulfate may also help docetaxel work better by making tumor cells more sensitive to the drug. Giving phenelzine sulfate together with docetaxel may kill more tumor cells.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the proportion of patients who experience a prostate specific antigen (PSA) decline of at least 30% within 12 weeks of initiation of combination therapy when phenelzine (phenelzine sulfate) is added to docetaxel in patients who have evidence of progression on standard docetaxel.
SECONDARY OBJECTIVES:
- To determine duration of progression free survival after initiation of combination phenelzine and docetaxel therapy.
II. To determine the response rate in measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria after initiation of combination phenelzine and docetaxel therapy.
III. To report the maximum change in PSA from baseline to 12 weeks (or earlier in patients who discontinue early) by waterfall plot after initiation of combination phenelzine and docetaxel therapy.
IV. To determine the toxicity of the combination regimen in castration-resistant prostate cancer (CRPC) previously treated with docetaxel.
- To determine time to death from all causes. VI. To determine the frequency of monoamine oxidase A (MAOA) overexpression in CRPC tumors that are progressing on docetaxel.
VII. To compare the level of MAOA expression in primary diagnostic tissue (e.g. biopsy or radical prostatectomy) with CRPC tumors that are progressing on docetaxel.
VIII. To correlate MAOA overexpression in CRPC tumors with response to combination study treatment.
IX. To collect blood and tissue specimens for future molecular correlative studies.
- To validate MAOA assessment in circulating tumor cells. XI. To assess correlation with tissue expression of MAOA. XII. To measure hypoxia-inducible factor (HIF)-1alpha expression and other potential biomarkers in circulating tumor cells as a potential measure of MAO activity.
TERTIARY OUTCOMES:
- To measure expression of lysine-specific histone demethylase 1 (LSD1) in CRPC tumors that are progressing on docetaxel and correlate with the endpoints described in the primary objective and secondary objectives I, II, III, and V.
II. To conduct gene expression studies in CRPC tumors that are progressing on docetaxel and correlate them with and correlate with the endpoints described in the primary objective and secondary objectives I, II, III and V.
OUTLINE: This is a dose-escalation study of phenelzine sulfate.
Patients receive phenelzine sulfate orally (PO) once daily (QD) on days -7 to -4, and then twice daily (BID) on days -3 to 21. Patients receive docetaxel intravenously (IV) over 60 minutes on day 1. Treatment repeats every 21 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months.
- Conditions
- Hormone-Resistant Prostate Cancer, Metastatic Prostatic Adenocarcinoma, Prostate Adenocarcinoma, Recurrent Prostate Carcinoma
- Being tested
- Biopsy of Prostate, Docetaxel, Laboratory Biomarker Analysis, Phenelzine Sulfate
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy of ProstateProcedure or surgery
Also called Prostate Biopsy, Prostatic Biopsy
Undergo transrectal ultrasound (TRUS) guided prostate biopsy OR image-guided (CT or ultrasound) core bone or soft tissue biopsy
DocetaxelDrug
Also called Docecad, RP56976, Taxotere, Taxotere Injection Concentrate
Given IV
Laboratory Biomarker AnalysisOther
Correlative studies
Phenelzine SulfateDrug
Also called Nardil
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Treatment (antiangiogenesis, chemosensitizer, chemotherapy) | Experimental | Patients receive phenelzine sulfate PO QD on days -7 to -4, and then BID on days -3 to 21. Patients receive docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity. Receives: Procedure: Biopsy of Prostate; Drug: Docetaxel; Other: Laboratory Biomarker Analysis; Drug: Phenelzine Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Who Experience a PSA (Prostate-Specific Antigen) Decline of at Least 30%
PSA response: A ≥ 30% reduction from baseline within 12 weeks of initiation of therapy (confirmed on a second measurement at least 3 weeks later).
Measured: Within 12 weeks
Secondary outcomes (8)
Duration of Progression Free Survival After Initiation of Combination Phenelzine and Docetaxel Therapy
Progression free survival is calculated as the time from Day 1 of Combination therapy to first evidence of progression (by PSA, Measureable Disease, or Clinical Progression). For subjects who did not meet progression criteria, date of new therapy or date of death was used. Outcome is reported as mean.
Measured: Up to 6 years
Frequency of MAOA (Monoamine Oxidase A) Overexpression in CRPC (Castration-Resistant Prostate Cancer) Tumors That Are Progressing on Docetaxel
Reported as Number of participants with MAOA expression greater than 5%.
Measured: Baseline
HIF-1alpha Expression in CTC (Circulating Tumor Cells) as a Potential Measure of MAO Activity
Measured: Up to 6 years
MAOA Expression in CTC (Circulating Tumor Cells) and Comparison to Biopsy MAOA Expression
A Pearson's correlation will be used to correlate tumor biopsy MAOA expression and circulating tumor cells MAOA expression.
Measured: Up to 6 years
Maximum Change in PSA
Measured from Day 1 of Combination therapy to PSA at 12 Weeks on therapy (or earlier if subject not on therapy for 12 weeks).
Measured: 12 weeks (or earlier in patients who discontinued early)
Response Rate in Measurable Disease by RECIST (Response Evaluation Criteria In Solid Tumors) Criteria
Response in measurable disease is defined as a 30% decrease in the sum of diameters of target lesions (as described by RECIST 1.1).
Measured: Up to 6 years
Time to Death From All Causes
Time to death is calculated from Day 1 of Combination therapy to death from any cause.
Measured: Up to 6 years
Toxicity of the Regimen
Number of participants who experienced an Adverse Event. Detail of Adverse Events is reported in the Adverse Event Section
Measured: Up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study start12 Jul 2010
- Primary completion15 Sep 2016
- Study completion15 Sep 2017
Why it stopped: low enrollment
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 Hormone-Resistant Prostate CancerStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), The Wayne D. Kuni and Joan E. Kuni Foundation
- Responsible party
- Principal investigator, Tom Beer, OHSU Knight Cancer Institute
- Investigators
- Tomasz Beer, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01253642
- Sponsor's protocol ID
- IRB00005688
- Other IDs
- NCI-2010-02037, SOL-09105-LM, 5688, OHSU-5688, e5688, MR00045508, MR46390, IRB00005688
- Status last verified
- Sep 2019
- First submitted
- 15 Nov 2010
- Last updated
- 2 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of MAOA Inhibitor Plus Docetaxel in Patients Receiving and Progressing on Docetaxel Therapy
- ClinicalTrials.gov ID
- NCT01253642
- Acronym / sponsor ID
- IRB00005688
- Conditions
- Hormone-Resistant Prostate Cancer, Metastatic Prostatic Adenocarcinoma, Prostate Adenocarcinoma, Recurrent Prostate Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low enrollment
- Enrolment
- 11 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), The Wayne D. Kuni and Joan E. Kuni Foundation
- Study start
- 12 Jul 2010
- Primary completion
- 15 Sep 2016 (actual)
- Study completion
- 15 Sep 2017 (actual)
- First posted
- 3 Dec 2010 (estimated)
- Results
- Posted 11 Dec 2017
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 studies how well giving phenelzine sulfate together with docetaxel works in treating patients with prostate cancer that is growing, spreading, or getting worse after first-line therapy with docetaxel. Phenelzine sulfate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Phenelzine sulfate may also help docetaxel work better by making tumor cells more sensitive to the drug. Giving phenelzine sulfate together with docetaxel may kill more tumor cells.
Detailed description
PRIMARY OBJECTIVES:
- To determine the proportion of patients who experience a prostate specific antigen (PSA) decline of at least 30% within 12 weeks of initiation of combination therapy when phenelzine (phenelzine sulfate) is added to docetaxel in patients who have evidence of progression on standard docetaxel.
SECONDARY OBJECTIVES:
- To determine duration of progression free survival after initiation of combination phenelzine and docetaxel therapy.
II. To determine the response rate in measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria after initiation of combination phenelzine and docetaxel therapy.
III. To report the maximum change in PSA from baseline to 12 weeks (or earlier in patients who discontinue early) by waterfall plot after initiation of combination phenelzine and docetaxel therapy.
IV. To determine the toxicity of the combination regimen in castration-resistant prostate cancer (CRPC) previously treated with docetaxel.
- To determine time to death from all causes. VI. To determine the frequency of monoamine oxidase A (MAOA) overexpression in CRPC tumors that are progressing on docetaxel.
VII. To compare the level of MAOA expression in primary diagnostic tissue (e.g. biopsy or radical prostatectomy) with CRPC tumors that are progressing on docetaxel.
VIII. To correlate MAOA overexpression in CRPC tumors with response to combination study treatment.
IX. To collect blood and tissue specimens for future molecular correlative studies.
- To validate MAOA assessment in circulating tumor cells. XI. To assess correlation with tissue expression of MAOA. XII. To measure hypoxia-inducible factor (HIF)-1alpha expression and other potential biomarkers in circulating tumor cells as a potential measure of MAO activity.
TERTIARY OUTCOMES:
- To measure expression of lysine-specific histone demethylase 1 (LSD1) in CRPC tumors that are progressing on docetaxel and correlate with the endpoints described in the primary objective and secondary objectives I, II, III, and V.
II. To conduct gene expression studies in CRPC tumors that are progressing on docetaxel and correlate them with and correlate with the endpoints described in the primary objective and secondary objectives I, II, III and V.
OUTLINE: This is a dose-escalation study of phenelzine sulfate.
Patients receive phenelzine sulfate orally (PO) once daily (QD) on days -7 to -4, and then twice daily (BID) on days -3 to 21. Patients receive docetaxel intravenously (IV) over 60 minutes on day 1. Treatment repeats every 21 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (antiangiogenesis, chemosensitizer, chemotherapy) | Experimental | Procedure: Biopsy of Prostate, Drug: Docetaxel, Other: Laboratory Biomarker Analysis, Drug: Phenelzine SulfatePatients receive phenelzine sulfate PO QD on days -7 to -4, and then BID on days -3 to 21. Patients receive docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for at least 12 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 (17 listed)
- Histological or cytological diagnosis of adenocarcinoma of the prostate
- Radiographic evidence of regional or distant metastases with suspected tumor in an area that is safe to biopsy
- Willingness to undergo tumor biopsy
- Evidence of CRPC indicated by history of progression despite standard hormonal therapy (by PSA and/or imaging studies)
- Planned or recent initiation of standard docetaxel therapy; patients may be enrolled after receiving standard docetaxel therapy as long as the patient has not demonstrated evidence of progression for more than 45 days before enrollment ("late enrollers")
Key exclusion criteria (11 listed)
- Significant peripheral neuropathy defined as grade 2 or higher
- A second active malignancy except adequately treated non-melanoma skin cancer or other non-invasive or in situ neoplasm
- Significant active concurrent medical illness or infection precluding protocol treatment or survival
- Current uncontrolled hyperthyroidism
- Pheochromocytoma
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 |
|---|---|---|
| Biopsy of ProstateAlso: Prostate Biopsy, Prostatic BiopsyUndergo transrectal ultrasound (TRUS) guided prostate biopsy OR image-guided (CT or ultrasound) core bone or soft tissue biopsy | Procedure or surgery | Treatment (antiangiogenesis, chemosensitizer, chemotherapy) |
| DocetaxelAlso: Docecad, RP56976, Taxotere, Taxotere Injection ConcentrateGiven IV | Drug | Treatment (antiangiogenesis, chemosensitizer, chemotherapy) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (antiangiogenesis, chemosensitizer, chemotherapy) |
| Phenelzine SulfateAlso: NardilGiven PO | Drug | Treatment (antiangiogenesis, chemosensitizer, chemotherapy) |
Primary outcome
Proportion of Patients Who Experience a PSA (Prostate-Specific Antigen) Decline of at Least 30%
Time frame: Within 12 weeks
PSA response: A ≥ 30% reduction from baseline within 12 weeks of initiation of therapy (confirmed on a second measurement at least 3 weeks later).
8 secondary outcomes
Duration of Progression Free Survival After Initiation of Combination Phenelzine and Docetaxel Therapy
Time frame: Up to 6 years
Frequency of MAOA (Monoamine Oxidase A) Overexpression in CRPC (Castration-Resistant Prostate Cancer) Tumors That Are Progressing on Docetaxel
Time frame: Baseline
HIF-1alpha Expression in CTC (Circulating Tumor Cells) as a Potential Measure of MAO Activity
Time frame: Up to 6 years
MAOA Expression in CTC (Circulating Tumor Cells) and Comparison to Biopsy MAOA Expression
Time frame: Up to 6 years
Maximum Change in PSA
Time frame: 12 weeks (or earlier in patients who discontinued early)
Response Rate in Measurable Disease by RECIST (Response Evaluation Criteria In Solid Tumors) Criteria
Time frame: Up to 6 years
Time to Death From All Causes
Time frame: Up to 6 years
Toxicity of the Regimen
Time frame: Up to 6 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Tomasz Beer principal investigator
OHSU Knight Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biopsy of Prostate, Docetaxel and Laboratory Biomarker Analysis in people with Hormone-Resistant Prostate Cancer and Metastatic Prostatic Adenocarcinoma, run by OHSU Knight Cancer Institute at 3 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 17 inclusion and 11 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 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Yes. Results are posted in the registry (first posted 11 Dec 2017). 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?
Proportion of Patients Who Experience a PSA (Prostate-Specific Antigen) Decline of at Least 30% (time frame: Within 12 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 2 Oct 2019.