Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Adenocarcinoma

Prostatic Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Tubulin Modulators

Antimitotic Agents

Docetaxel (TAXOTERE) will be given for up to 6 cycles every 21 days. During the 5th and 6th cycles, degarelix (Firmagon) will be administered on Cycle 5 day 1 and cycle 6 day 8. After cycle 6, degarelix will continue to be given every 28 days for a 5 more doses, for a total of 7 doses.

The docetaxel dose is a 75mg/m2 intravenous (given through the vein) injection.

Degarelix will be given as a subcutaneous (given under the skin) injection in the abdomen. The first dose will be a 240mg dose; all other doses will be 80 mg.

Degarelix

The purpose of this study is to look at patient outcomes when docetaxel is started prior to ADT with degarelix.

This study will look at two drugs, docetaxel and degarelix, which are both FDA approved for the treatment of prostate cancer. Docetaxel is a standard chemotherapy treatment for metastatic prostate cancer. Degarelix is an androgen deprivation therapy (ADT) agent that decreases the amount of testosterone in the body, which helps to fight tumor growth. Usually, docetaxel is given after ADT. This study will look at how your cancer changes when docetaxel is started before ADT. You are being asked to participate in this study because you have metastatic prostate cancer that can be treated with docetaxel and ADT.

Phase II Study of Docetaxel Before Degarelix in Patients With Newly Diagnosed Metastatic Prostate Cancer.

A Phase II Study of Docetaxel Before Medical Castration With Degarelix in Patients With Newly Diagnosed Metastatic Prostatic Adenocarcinoma.

PSA complete response is defined as PSA level less than or equal to 0.2 ng/ml for two consecutive measurements at least three weeks apart. Date of complete response will be defined as the date of first recorded value less than 0.2 ng/ml. PSA partial response is defined as a decline of PSA from trial baseline of \> 50% for two consecutive measurements at least three weeks apart. Date of partial response will be defined as the date of first recorded decline of \> 50% baseline. Date of partial response will be defined as the date of first recorded decline of \> 50% baseline. PSA progression will be defined as \> 25% increase from the PSA nadir (lowest PSA value recorded since trial enrollment) and \> 2 ng/dl above the nadir. Two consecutive increases must be recorded at least three weeks apart. Date of PSA progression will be defined as the first recorded PSA value that is a \> 25% increase from the PSA nadir and \> 2 ng/dl above the nadir.

Toxicity for all evaluable patients will be defined by CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0.

PSA progression will be defined as \> 25% increase from the PSA nadir (lowest PSA value recorded since trial enrollment) and \> 2 ng/dl above the nadir. Two consecutive increases must be recorded at least two weeks apart. Date of PSA progression will be defined as the first recorded PSA value that is a \> 25% increase from the PSA nadir and \> 2 ng/dl above the nadir. PSA progression will not be established during the first 12 weeks of therapy (4 cycles of docetaxel) as defined by PCWG2 criteria. Thus subjects with no PSA decline from baseline during therapy will have date of PSA progression defined as first PSA value after 12 weeks that is a \> 25% increase from the PSA nadir and \> 2 ng/dl above the nadir.

PSA complete response is defined as PSA level less than or equal to 0.2 ng/ml for two consecutive measurements at least two weeks apart. Date of complete response will be defined as the date of first recorded value less than 0.2 ng/ml.

PSA Partial Response is defined as a decline of PSA from trial baseline of \> 50% for two consecutive measurements at least two weeks apart. Date of partial response will be defined as the date of first recorded decline of \> 50% baseline.

PSA progression is defined in outcome 4.

This will be defined as the time from initial Degarelix injection to the time of disease progression (clinical, radiographic or PSA. Determination of castration resistant disease status will require disease progression and a measured serum testosterone level less than 50 ng/dl.

Progression free Survival (PFS) will be defined as the duration of time from start of study treatment to time of disease progression or death, whichever comes first.

OS is defined as the time interval from trial enrollment to death due to any cause. Survival times will be censored for patients lost to follow-up or still alive at the trial's termination.

Ferring Pharmaceuticals

Medical University of South Carolina

Symptoms and General Pathology

Recurrence

Disease Progression

Psychotropic Drugs

Phenelzine

Antidepressive Agents

Monoamine Oxidase Inhibitors

Enzyme Inhibitors

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.

Undergo transrectal ultrasound (TRUS) guided prostate biopsy OR image-guided (CT or ultrasound) core bone or soft tissue biopsy

Biopsy of Prostate

Laboratory Biomarker Analysis

Phenelzine Sulfate

Tomasz Beer

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.

PRIMARY OBJECTIVES:

I. 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:

I. 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.

V. 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.

X. 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:

I. 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.

Phenelzine Sulfate and Docetaxel in Treating Patients With Prostate Cancer With Progressive Disease After First-Line Therapy With Docetaxel

A Phase II Study of MAOA Inhibitor Plus Docetaxel in Patients Receiving and Progressing on Docetaxel Therapy

PSA response: A ≥ 30% reduction from baseline within 12 weeks of initiation of therapy (confirmed on a second measurement at least 3 weeks later).

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.

Reported as Number of participants with MAOA expression greater than 5%.

A Pearson's correlation will be used to correlate tumor biopsy MAOA expression and circulating tumor cells MAOA expression.

Measured from Day 1 of Combination therapy to PSA at 12 Weeks on therapy (or earlier if subject not on therapy for 12 weeks).

Response in measurable disease is defined as a 30% decrease in the sum of diameters of target lesions (as described by RECIST 1.1).

Time to death is calculated from Day 1 of Combination therapy to death from any cause.

Number of participants who experienced an Adverse Event. Detail of Adverse Events is reported in the Adverse Event Section

National Cancer Institute (NCI)

The Wayne D. Kuni and Joan E. Kuni Foundation

OHSU Knight Cancer Institute

Principal Investigator

Serious Adverse Events are considered Serious only if they are both unexpected and related to study. Hospitalizations that are expected for these study agents or the study population are not considered Serious Adverse Events.

Only Adverse Events that are considered possibly or definitely related to the study are reported.

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.

Combination Phenelzine and Docetaxel

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Early termination leading to small numbers of subjects analyzed; overall morbidity of patient population prohibited long term treatment or follow-up.

Kristi Eilers

Proportion of Patients Who Experience a PSA (Prostate-Specific Antigen) Decline of at Least 30%

1 subject withdrew from the study before the first evidence of progression and is not included in this progression free survival analysis.

Duration of Progression Free Survival After Initiation of Combination Phenelzine and Docetaxel Therapy

Subjects who had evaluable samples collected immediately prior to initiation of Combination Therapy. 3 subjects did not have evaluable samples and were not included in this analysis.

Frequency of MAOA (Monoamine Oxidase A) Overexpression in CRPC (Castration-Resistant Prostate Cancer) Tumors That Are Progressing on Docetaxel

Of eleven subjects, CTC samples were collected from only 3. No testing was conducted on these 3 samples.

HIF-1alpha Expression in CTC (Circulating Tumor Cells) as a Potential Measure of MAO Activity

MAOA Expression in CTC (Circulating Tumor Cells) and Comparison to Biopsy MAOA Expression

1 subject withdrew from the study before reaching 12 weeks and is not included in this progression free survival analysis.

Maximum Change in PSA

3 subjects were excluded from this response rate calculation as they did not have additional scans beyond baseline.

Response Rate in Measurable Disease by RECIST (Response Evaluation Criteria In Solid Tumors) Criteria

Time to Death From All Causes

Toxicity of the Regimen

Overall Study

Immune System Diseases

Hypersensitivity

Anti-Inflammatory Agents

Micronutrients

Vitamins

Androgens

Hormones

Abiraterone Acetate

Prednisone

Cortisone

Androgen Antagonists

Ascorbic Acid

Methyltestosterone

Testosterone

Testosterone undecanoate

Testosterone enanthate

Testosterone 17 beta-cypionate

Estrogens, Conjugated (USP)

Estrogens

Glucocorticoids

Hormone Antagonists

Antineoplastic Agents, Hormonal

Cytochrome P-450 Enzyme Inhibitors

Antioxidants

Protective Agents

Trace Elements

Anabolic Androgenic Steroids

Anabolic Agents

Vitamin C

Participants receive androgen deprivation therapy (ADT) per standard of care and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Participants receive androgen deprivation therapy (ADT) per standard of care, abiraterone acetate PO daily, and prednisone PO twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Antiandrogen Therapy

Quality-of-Life Assessment

Questionnaire Administration

Benjamin Maughan, MD

This phase II trial studies how well docetaxel or abiraterone acetate work when combined with androgen deprivation therapy (ADT) in treating patients with hormone sensitive prostate cancer that has spread to other parts of the body. Drugs used in chemotherapy, such as docetaxel and abiraterone acetate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Antihormone therapy, such as ADT may lessen the amount of androgen made by the body. It is not yet known whether docetaxel or abiraterone acetate work better when combined with ADT in treating patients with hormone sensitive prostate cancer.

PRIMARY OBJECTIVES:

I. To assess the impact of abiraterone acetate (abiraterone) and docetaxel on total quality of life between screening and month 12 of the study.

SECONDARY OBJECTIVES:

I. To assess prostate specific androgen (PSA) response rates across the entire population and compared between groups.

II. To assess impact of abiraterone and docetaxel on additional quality of life measurements and quality of life trends throughout the duration of the study.

III. To assess the potential clinical efficacy between treatment groups.

Docetaxel or Abiraterone Acetate With ADT in Treating Patients With Metastatic Hormone Sensitive Prostate Cancer

ACADEMIC: A Randomized Phase II Clinical Trial of ADT Combined With Abiraterone or Docetaxel in Metastatic Hormone Sensitive Prostate Cancer

The impact of abiraterone acetate and docetaxel on health related quality of life will be assessed every 3 months from screening to month 12 of treatment or follow-up. The scale used will be the Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale. The total score ranges from 0 to 156, with higher scores indicating a higher quality of life. The primary endpoint was intended to be quality of life at 12 months, but since no participants completed 12 months of treatment/follow-up, scores at baseline and 3 months are reported instead.

PSA evaluations will occur every 3 months while on study. PSA response is defined as a reduction in PSA value of greater than or equal to 90% from baseline, reported as a count of participants who had a PSA response on the study.

Quality of Life questionnaires will be done every 3 months while participants are on treatment. The scale used will be the Functional Assessment of Cancer Therapy (FACT)/Gynecologic Oncology Group (GOG)-Neurotoxicity (NTX) (FACT/GOG-NTX) scale (version 4). FACT/GOG-NTX total score ranges from 0 to 152, with higher scores indicating a higher quality of life.

Quality of Life questionnaires will be done every 3 months while participants are on treatment. The scale used will be the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue scale. Total raw scores range from 7 to 35, with higher scores indicating a higher level of fatigue.

Prostate Specific Antigen (PSA) will be measured every three months while on study. PSA Progression Free Survival (PSA-PSF) will be reported as the number of participants who have not demonstrated PSA progression by the end of the follow-up period. PSA progression is defined by meeting the following criteria: 1) an increase in PSA of greater than or equal to 25% from baseline or nadir, AND 2) an increase in PSA of at least 2 ng/dL, AND 3) the increase is confirmed at least 3 weeks later. This analysis was planned for up to 18 months following study enrollment, but the only participant enrolled on the study was only followed for 3 months.

University of Utah

Information about adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, lab test or other means, were abstracted from clinic notes and recorded in the participant's study chart. The safety profile for the drugs involved in this study have been characterized extensively in previous clinical trials and standard clinical contexts. As such, safety data collection for this study was limited to ≥ Grade 3 adverse events.

Participants receive ADT per standard of care and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Arm A (ADT, Docetaxel)

Participants receive ADT per standard of care, abiraterone acetate PO daily, and prednisone PO twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Arm B (ADT, Abiraterone)

Total

Age, Categorical

Because only one participant enrolled, the baseline characteristics were not provided to protect the identify and privacy of the participant.

Data Manager

Baseline Score

Month 3 Score

There were no participants on Arm B to analyze.

Change in Quality of Life - FACT-P

Prostate-specific Antigen (PSA) Response

Change in Quality of Life - FACT/GOG-NTX

Change in Quality of Life - PROMIS Fatigue

There were no participants on Arm B to be analyzed.

Prostate Specific Antigen Progression Free Survival (PSA-PFS)

Intravenous injection of 100 mCi of 131I-PSMA-1095 RLT, Q8 weeks up to a maximum of 4 doses

Intravenous injection of 100 mCi of 131I-PSMA-1095, Q8 weeks up to a maximum of 4 doses.

131I-PSMA-1095 Radioligand Therapy (RLT)

Stephan Probst, MD

Single-arm, open-label, phase II trial in 200 competent adult male patients with Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-3 and progressive metastatic prostate cancer, failing, failed, refused, not eligible for or no access to further approved lines of therapy. Patients will undergo sequential FDG positron emission tomography (PET) and 18F-DCFPyL PET to assess FDG/DCFPyL concordance fraction. Patients with DCFPyL/FDG concordance of 50% or greater will be treated with 131I-PSMA-1095 radioligand therapy (RLT). Best post-treatment serum prostate specific antigen response will be compared to concordance fraction.

Two TraCer PositROn EmiSSion Tomography ComBination for Efficacy EstimatiOn of Prostate Specific Membrane Antigen Radioligand Therapy in Patients With Metastatic Prostate Cancer

The best serum prostate specific antigen (PSA) response will be calculated for each patient as: pre-treatment PSA minus lowest post-treatment PSA divided by pre-treatment PSA. Best PSA response will be reported as percent reduction (or increase) from baseline.

Frequency of adverse events in participants receiving therapy as per CTCAE v5.0

Sir Mortimer B. Davis - Jewish General Hospital

Chief of Nuclear Medicine

Anti-Infective Agents

Dermatologic Agents

Reproductive Control Agents

Amino Acids

Salicylic Acid

Leuprolide

Goserelin

Triptorelin Pamoate

Tryptophan

Bicalutamide

Flutamide

Nilutamide

Contraceptive Agents

Contraceptive Agents, Female

Contraceptive Agents, Hormonal

Participants receive 1 acceptable form of SST as in Induction except for treatment with docetaxel and prednisone.

Participants receive 1 acceptable form of SST as in Induction except for treatment with docetaxel and prednisone. Participants undergo prostatectomy within 8 weeks after randomization or radiation therapy within 4 weeks of randomization.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase II Study of Docetaxel Before Degarelix in Patients With Newly Diagnosed Metastatic Prostate Cancer.	NCT03069937	Metastatic Pros...	Docetaxel Degarelix	18 Years -	Medical University of South Carolina
Phenelzine Sulfate and Docetaxel in Treating Patients With Prostate Cancer With Progressive Disease After First-Line Therapy With Docetaxel	NCT01253642	Hormone-Resista... Metastatic Pros... Prostate Adenoc... Recurrent Prost...	Biopsy of Prost... Docetaxel Laboratory Biom... Phenelzine Sulf...	18 Years -	OHSU Knight Cancer Institute
Docetaxel or Abiraterone Acetate With ADT in Treating Patients With Metastatic Hormone Sensitive Prostate Cancer	NCT03827473	Castration-Sens... Metastatic Pros... Stage IV Prosta... Stage IVA Prost... Stage IVB Prost...	Abiraterone Ace... Antiandrogen Th... Docetaxel Prednisone Quality-of-Life... Questionnaire A...	18 Years -	University of Utah
Two TraCer PositROn EmiSSion Tomography ComBination for Efficacy EstimatiOn of Prostate Specific Membrane Antigen Radioligand Therapy in Patients With Metastatic Prostate Cancer	NCT04085991	Prostate Cancer Prostate Adenoc... Prostatic Neopl... Metastatic Pros... Metastatic Pros... Metastatic Pros...	131I-PSMA-1095 ...	18 Years -	Sir Mortimer B. Davis - Jewish General Hospital
Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer	NCT03678025	Castration Leve... Metastatic Pros... Stage IV Prosta... Stage IVA Prost... Stage IVB Prost...	Abiraterone Bicalutamide Degarelix Docetaxel Flutamide Goserelin Aceta... Histrelin Aceta... Leuprolide Acet... Nilutamide Orchiectomy Prednisone Quality-of-Life... Radiation Thera... Radical Prostat... Triptorelin	18 Years -	SWOG Cancer Research Network
A Phase 2 Trial for Men With Metastatic Prostatic Adenocarcinoma	NCT04090775	Metastatic Pros...	Opdivo Injectab... Yervoy Injectab... Cytoxan Cryosurgical fr...	18 Years -	Rampart Health, L.L.C.
Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer	NCT03678025	Castration Leve... Metastatic Pros... Stage IV Prosta... Stage IVA Prost... Stage IVB Prost...	Abiraterone Bicalutamide Degarelix Docetaxel Flutamide Goserelin Aceta... Histrelin Aceta... Leuprolide Acet... Nilutamide Orchiectomy Prednisone Quality-of-Life... Radiation Thera... Radical Prostat... Triptorelin	18 Years -	SWOG Cancer Research Network

Spots Global Cancer Trial Database for metastatic prostatic adenocarcinoma