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Prostap Medical Research Studies

Up-to-date List of Prostap Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Prostap Medical Research Studies

Rank Status Study
1 Recruiting Study of (1) Everolimus, (2) Estrogen Deprivation Therapy (EDT) With Leuprolide + Letrozole and (3) Everolimus + EDT in Patients With Unresectable Fibrolamellar Hepatocellular Carcinoma (FLL-HCC)
Conditions: Fibrolamellar Carcinoma;   Fibrolamellar Liver Cancer
Interventions: Drug: everolimus;   Drug: letrozole plus leuprolide;   Drug: combination of everolimus, letrozole and leuprolide
Outcome Measures: efficacy endpoints for Part 1 of the study is progression-free survival at 6 months (PFS6);   median PFS;   median overall survival (OS);   response rate;   to evaluate toxicity in patients;   correlative serum;   tissue biomarker studies;   to evaluate safety in patients
2 Recruiting Pilot Study of Lupron to Improve Immune Function After Allogeneic Bone Marrow Transplantation
Conditions: Acute Lymphocytic Leukemia;   Acute Myelogenous Leukemia;   Myelodysplastic Syndrome RAEB 1
Interventions: Drug: Lupron;   Drug: 18F FLT;   Drug: Cyclophosphamide;   Drug: Methotrexate;   Drug: Tacrolimus;   Drug: Total Body Irradiation
Outcome Measures: To determine if Lupron improves B lymphocyte reconstitution after HSCT.;   To assess whether 18F FLT PET/CT could predict early engraftment/immune reconstitution in marrow and thymus after allogeneic HSCT.;   To investigate whether Lupron will decrease the incidence of acute or chronic GVHD without altering GVT after allogeneic HSCT.;   To evaluate if Lupron decreases the incidence of infections after HSCT.
3 Recruiting Palifermin With or Without Leuprolide Acetate Versus Control for the Promotion of Immune Recovery Following Total Body Irradiation Based T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation
Conditions: Leukemia;   Multiple Myeloma;   Myelodysplastic Syndrome;   Non-Hodgkin's Lymphoma
Interventions: Biological: Palifermin;   Biological: Lupron;   Other: without the addition of palifermin or Lupron;   Procedure: peripheral blood stem cell transplantation
Outcome Measures: a CD4+ T cell count of greater than 200;   Overall Survival;   Transplant Related Mortality;   Incidence of infections;   Relapse
4 Not yet recruiting A Study in Patients With Metastatic Prostate Cancer to Assess How the Drug Eligard®, Affects Certain Markers in Blood and Urine, Which Are Indicators for the Disease
Condition: Metastatic Prostate Cancer
Intervention: Drug: Eligard
Outcome Measures: Changes from baseline of Testosterone levels in serum;   Changes from baseline of PSA level in serum;   Changes from baseline of PCA3 score in urine;   Changes from baseline of Number of PSA mRNA copies in blood/PBMC;   Changes from baseline of Number of PCA3 mRNA copies in blood/PBMC;   Changes from baseline of Number of TMPRSS2-ERG mRNA copies in blood/PBMC;   Number of Adverse Events from screening to the end of study visit (as reported by the investigator based on Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.3)
5 Recruiting Phase III Study : Enantone LP 11.25 mg (Leuprorelin) Effect on the Histological Progression of Indolent Prostate Cancer
Condition: Prostate Cancer
Interventions: Drug: Enantone LP 11.25 mg (1 injection) + Surveillance;   Other: active surveillance
Outcome Measures: Comparison of the number of patients with negative biopsies at 12 months;   Gleason score Anxiety evaluation (HADS)/ Erectile function evaluation;   the progression over time of disease clinical symptoms (IPSS score);   the tumour radiological progression by dynamic MRI;   the PSA levels progression;   the anxiety score on HAD Scale;   the International Index of Erectile Function (IIEF-5) Questionnaire
6 Recruiting GnRH-a for Ovarian Protection During CYC Therapy for Rheumatic Diseases
Conditions: Lupus Erythematosus, Systemic;   Systemic Vasculitis;   Isolated Angiitis of Central Nervous System;   Lung Disease With Systemic Sclerosis;   Lung Disease Interstitial Diffuse
Interventions: Drug: depot leuprolide acetate 3.75 mg;   Drug: Placebo
Outcome Measures: anti-mullerian hormone (AMH) measured as a continuous variable, specifically assessing the intra-person change from study entry (Day 0) to 6-month post-intervention visit;   Proportion of patients with AMH of ≤1.0 ng/mL vs >1 ng/mL, presence of menses, presence of either an AMH level of >1 ng/mL OR antral follicle count of >4. Continuous measures include: antral follicle count (AFC), ovarian volume, and FSH.
7 Recruiting An Observational Study Looking at How Well the Drug Eligard Works and How Well it is Tolerated by the Body of Patients With Advanced Prostate Carcinoma in the Russian Federation
Condition: Advanced Prostate Carcinoma
Intervention: Drug: Eligard 45 mg Exposure
Outcome Measures: Percentage change in total serum PSA;   Percentage change in testosterone levels;   Number of adverse drug reactions;   Mean change in QoL based on EuroQOL five dimensions questionnaire (EQ-5D)
8 Recruiting A Phase 3 Comparative Study of TAP-144-SR(6M) in Prostate Cancer Patients Previously Treated With Hormonal Therapy
Condition: Prostate Cancer
Interventions: Drug: TAP-144-SR(6M);   Drug: TAP-144-SR(3M)
Outcome Measure: The rate of suppression of serum testosterone to castrate level
9 Recruiting A Phase 3 Comparative Study of TAP-144-SR(6M) in Postoperative and Hormone Therapy-naïve Patients With Premenopausal Breast Cancer
Condition: Premenopausal Breast Cancer
Interventions: Drug: TAP-144-SR(6M);   Drug: TAP-144-SR(3M)
Outcome Measure: The suppression rate of serum estradiol(E2) to menopausal level
10 Recruiting Preservation of Ovarian Function After Hematopoietic Cell Transplant
Conditions: Multiple Myeloma;   Non-Hodgkin Lymphoma;   Hodgkin Disease;   Acute Myeloid Leukemia;   Myeloproliferative Disorders
Interventions: Drug: Leuprolide;   Biological: hematopoietic cell transplant;   Biological: reduced intensity allogeneic HCT
Outcome Measures: Comparison of Number of Patients with Ovarian Failure;   Comparison of Number of Participants Who Stopped Menstrual Bleeding;   Comparison of Follicle Stimulating Hormone (FSH) Levels;   Comparison of Number of Participants Who Resumed Menstrual Cycles;   Comparison of Leuprolide Hormone (LH) Levels;   Comparison of Antimullerian Hormone (AMH) Levels After Transplant
11 Unknown  Effect of Short Term Ovarian Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess
Conditions: Hyperandrogenemia;   Obesity;   Polycystic Ovary Syndrome
Interventions: Drug: Leuprolide;   Drug: Dexamethasone;   Drug: recombinant human chorionic gonadotropin
Outcome Measures: 17 hydroxyprogesterone responses to rhCG before and 4 weeks after depot leuprolide administration;   Ovarian hormone precursor responses to rhCG before and 4 weeks after depot leuprolide administration
12 Recruiting Finite Androgen Ablation vs. Finite Androgen Ablation in Combination With Abiraterone Acetate and Prednisone
Condition: Prostate Cancer
Interventions: Drug: Lupron;   Drug: Zoladex;   Drug: Degarelix;   Drug: Abiraterone Acetate;   Drug: Prednisone
Outcome Measure: Prostate Specific Antigen (PSA) Free Survival
13 Unknown  Leuprolide in Treating Adults With Hypogonadotropism
Condition: Hypogonadism
Intervention: Drug: leuprolide
Outcome Measure:
14 Unknown  Leuprolide in Determining the Cause of Gonadotropin Deficiency
Condition: Hypogonadism
Interventions: Drug: gonadotropin releasing hormone;   Drug: leuprolide
Outcome Measure:
15 Recruiting Surgery With or Without Docetaxel and Leuprolide or Goserelin in Treating Patients With High-Risk Localized Prostate Cancer
Condition: Prostate Cancer
Interventions: Drug: docetaxel;   Drug: goserelin acetate;   Drug: leuprolide acetate;   Procedure: conventional surgery
Outcome Measures: 3-year biochemical progression-free survival (bPFS) rate;   5-year bPFS rate and bPFS;   Time to clinical local recurrence;   Time to metastatic disease progression;   Unacceptable toxicity;   Prostate cancer-specific-free survival;   Disease progression;   Overall survival;   Death
16 Not yet recruiting The Effect of GnRH Agonist Administered in the Luteal Phase on ART Cycle Outcomes
Condition: Infertility
Interventions: Drug: Leuprolide acetate;   Drug: vaginal progesterone;   Drug: 4 mg oral estradiol valerate
Outcome Measures: Live Birth Rate;   Ongoing pregnancy;   miscarriage;   OHSS
17 Recruiting A Study to Assess the Effectiveness and Safety of Different Doses of ASP1707 Compared to Placebo for Endometriosis Associated Pelvic Pain
Condition: Endometriosis
Interventions: Drug: ASP1707;   Drug: Placebo;   Drug: Leuprorelin acetate
Outcome Measures: Change from baseline to the end of 12 weeks treatment of pain score for overall pelvic pain;   Change from baseline to the end of 12 weeks treatment of pain score for dysmenorrhea;   Change from baseline to the end of 12 weeks treatment of pain score for non-menstrual pelvic pain;   Change from baseline to the end of 24 weeks treatment of pain score for overall pelvic pain;   Change from baseline to the end of 24 weeks treatment of pain score for dysmenorrhea;   Change from baseline to the end of 24 weeks treatment of pain score for non-menstrual pelvic pain;   Change from baseline to the end of treatment (EoT) of the dyspareunia score;   Occurrence of response at the EoT for pain score for overall pelvic pain, dysmenorrhea, non-menstrual pelvic pain and dyspareunia;   Change from baseline to the EoT of the mean scores of the modified Biberoglu and Behrman (B&B) symptom and sign domains;   Change from baseline to the EoT of the use of protocol defined rescue medication;   Change from baseline to the EoT of the mean Pain Interference score of the Brief Pain Inventory;   Patient Global Impression of Change (PGIC) at the End of Treatment;   Change from baseline to the EoT in the Endometriosis Health Profile (EHP)-5 score;   Change from baseline to the EoT of the Female Sexual Function Index (FSFI) score (sexual well-being);   Change from baseline to the EoT of the Beck's Depression Inventory (BDI)-II score;   Change from baseline to the EoT in the EuroQol (EQ-5D-5L) score;   Safety and tolerability of ASP1707 measured by Adverse Events (AEs), bleeding patterns, Bone Mineral Density (BMD);   Pharmacodynamic profile of ASP1707 measured by Serum Estradiol (E2) levels;   Pharmacokinetic profile of ASP1707
18 Not yet recruiting Efficacy of Recombinant FSH/GnRH Antagonist Protocol With and Without LH Adjunct for Egg Bank Donation
Condition: Egg Donation
Interventions: Drug: Follistim;   Drug: Ganirelix;   Drug: Menotropins;   Drug: Leuprolide;   Procedure: Transvaginal ultrasound guided needle aspiration of oocytes
Outcome Measures: number of mature oocytes recovered and cryopreserved.;   1) #Days of ovarian stimulation to GnRH agonist trigger.;   2) Peak serum estradiol level on day of GnRH agonist trigger;   Number of follicles >15 mm average diameter on day of GnRH agonist trigger
19 Recruiting Postoperative Radiation Therapy, Hormonal Therapy and Concurrent Docetaxel for High Risk Pathologic T2-T3N0 Prostate Cancer
Condition: Prostate Cancer
Interventions: Drug: Docetaxel;   Radiation: Radiation Therapy;   Drug: Casodex and Zoladex (or Lupron)
Outcome Measure: To determine whether greater than or equal to 95% of patients who undergo adjuvant hormonal therapy, radiation therapy and docetaxel after a radical prostatectomy can safely tolerate and complete this regimen.
20 Unknown  Everolimus, Bicalutamide, and Leuprolide Acetate in Treating Patients Undergoing Radiation Therapy For High-Risk Locally Advanced Prostate Cancer
Condition: Prostate Cancer
Interventions: Drug: bicalutamide;   Drug: everolimus;   Drug: leuprolide acetate;   Radiation: external beam radiation therapy
Outcome Measures: Acute and late toxicities;   Biochemical-free survival;   Metastasis-free survival;   Overall survival;   Pre-treatment molecular characteristics of the tumor and its correlation with outcomes

These studies may lead to new treatments and are adding insight into Prostap etiology and treatment.

A major focus of Prostap research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.


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