Subscribe

Select Clinical Trials Currently Recruiting Patients with Prostate Cancer

Urology Practice Management - October 2016, Vol 5, No 5 - Clinical Trials Tracker

The following clinical trials represent a selection of key studies that are currently recruiting patients with prostate cancer for investigations of new treatments or new combinations for patients with prostate cancer. Each clinical trial description includes the NLM Identifier used by ClinicalTrials.gov. The information below can help urologists direct their eligible patients to one of these studies.

1. Radium 223 Dichloride After Intermittent ADT in Localized Prostate Cancer

The purpose of this phase 2, randomized, open-label, parallel-assignment clinical trial is to evaluate the efficacy and safety of monthly radium 223 dichloride (Xofigo) in prolonging the off-treatment interval for men with localized prostate cancer receiving intermittent androgen ablation therapy for a rising prostate-specific antigen (PSA) level postradiation or postprostatectomy, who are at high risk for occult metastases. Men aged 45 to 85 years with a Gleason score of >8, and with PSA >5 ng/mL and <100 ng/mL and rising on 2 successive occasions at least 1 month apart before androgen-deprivation therapy (ADT), may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive radium 223 dichloride or no treatment.

The primary outcome measures are PSA levels >5 ng/mL and time to PSA levels >5 ng/mL in the off-treatment interval during intermittent androgen ablation therapy, as measured from randomization. This study plans to enroll 106 patients at the Sunnybrook Health Sciences Centre in Ontario, Canada. For more information, contact Laurence Klotz, MD, at 416-480-4673. The NLM Identifier is NCT02656563.

2. Pain Evaluation in Radium 223–Treated Castration-Resistant Prostate Cancer Patients with Bone Metastases: The PARABO Study

The purpose of this observational, prospective clinical trial is to assess pain and bone pain–related quality of life of patients with metastatic castration-resistant prostate cancer (CRPC) receiving radium 223 dichloride (Xofigo) in a real-life nuclear medicine practice setting. In addition, overall survival, time to next tumor treatment, time to first symptomatic skeletal event, course of blood counts, and safety will be assessed. Men aged ≥18 years with CRPC with symptomatic bone metastases without known visceral metastases may be eligible for enrollment if other criteria are met. Eligible patients will receive radium 223 dichloride.

The primary outcome measure is pain response. The secondary outcome measures include change in pain over time, change in bone pain–related quality of life, pain control rate, pain progression rate, time to first pain progression, time to first opioid use, summary evaluation of covariates on pain response, relationship between bone uptake in known lesions and pain palliation, dosage of radium 223 dichloride, number of injections of radium 223 dichloride, course of blood count presented as percentage of patients below limit for further injections according to the local product information, number of participants with treatment-emergent adverse events, time to next tumor treatment, time to first symptomatic skeletal event, overall survival, and bone scan index as imaging biomarker in metastatic CRPC. This study expects to enroll 300 patients in Germany. For more information, contact Bayer Clinical Trials, at clinical-trials-contact@bayerhealthcare.com. The NLM Identifier is NCT02398526.

3. Radium 223 Dichloride in Castration-Resistant Prostate Cancer with Bone Metastases

This observational, prospective, postmarketing surveillance study will confirm the clinical usefulness of radium 223 dichloride (Xofigo) in routine clinical practice. Male children, adults, and seniors with CRPC with bone metastases may be eligible for enrollment if other criteria are met. Eligible patients will receive radium 223 dichloride.

The primary outcome measures include the number of adverse events and the number of adverse drug reactions as a measure of safety. The secondary outcome measures include change in laboratory findings and change in analgesic use as a surrogate of pain status. This study expects to enroll 300 patients in Japan. For more information, contact Bayer Clinical Trials, at clinical-trials-contact@bayer.com. The NLM Identifier is NCT02803437.

4. Long-Term Safety of Radium 223 Dichloride for Metastatic Castration-Resistant Prostate Cancer:The REASSURE Study

The purpose of this phase 4, prospective, observational study is to evaluate the short- and long-term safety profile of radium 223 dichloride (Xofigo) in patients with metastatic CRPC and to assess the risk for second primary cancers. Men aged ≥18 years with histologically or cytologically confirmed castration-resistant adenocarcinoma of the prostate with bone metastases may be eligible for enrollment if other criteria are met. Eligible patients will receive radium 223 dichloride.

The primary outcome measures include incidence of second primary malignancies, incidence of treatment-emergent adverse events, incidence of drug-related treatment- emergent adverse events, incidence of drug-related serious adverse events, and bone marrow suppression. The secondary outcome measures include overall survival (OS) and the worst pain score and pain interference score over time, as determined by patient responses on the Brief Pain Inventory Short Form questionnaire. This study expects to enroll 1334 patients across multiple locations in the United States and abroad. For more information, contact Bayer Clinical Trials Contact at 888-842-2937, or clinical-trials-contact@bayer.com. The NLM Identifier is NCT02141438.

5. Enzalutamide Monotherapy or in Combination with Abiraterone and Prednisone in Patients with Metastatic Castration-Resistant Prostate Cancer

This phase 3, randomized, open-label, parallel-assignment clinical trial assesses the efficacy of enzalutamide (Xtandi) with or without abiraterone (Zytiga) and prednisone in patients with metastatic CRPC. Men aged ≥18 years with documented disease-progressive CRPC and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 may be eligible for enrollment if other criteria are met. Eligible patients will receive enzalutamide monotherapy or enzalutamide in combination with abiraterone and prednisone.

The primary outcome measure is OS. The secondary outcome measures include grade ≥3 toxicity, PSA levels, radiographic progression-free survival (PFS), objective response rate, ability of radiographic PFS to predict OS, tumor burden and bone activity, and development and validation of prognostic and predictive models of OS. This study expects to enroll 1224 patients at multiple locations across the United States and Canada. For more information, contact Michael Morris, MD, at 646-422-4469. The NLM Identifier is NCT01949337.

6. Enzalutamide as First-Line ADT for Metastatic Prostate Cancer: The ENZAMET Study

The purpose of this randomized, open-label, parallel-assignment, phase 3 clinical trial is to determine the efficacy of enzalutamide versus a conventional nonsteroidal antiandrogen (NSAA) therapy, when combined with a luteinizing hormone-releasing hormone analog or surgical castration, as first-line ADT for patients with newly diagnosed metastatic prostate cancer. Men aged ≥18 years with metastatic adenocarcinoma of the prostate and an ECOG performance status of 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients will receive enzalutamide or conventional NSAA.

The primary outcome measure is OS. The secondary outcome measures include PSA PFS, clinical PFS time, adverse events, health-related quality of life, and healthcare resource cost-effectiveness. This study plans to enroll 1100 patients at multiple locations across the United States and abroad. For more information, contact ENZAMET trial coordinator at enzamet@ctc.usyd.edu.au. The NLM Identifier is NCT02446405.

7. Cabazitaxel and Pelvic Radiotherapy in Localized Prostate Cancer and High-Risk Features of Relapse: The PEACE2 Study

The purpose of this randomized, open-label, factorial-assignment, phase 3 clinical trial is to assess the effect of neoadjuvant cabazitaxel (Jevtana) and pelvic radiotherapy in combination with ADT radiotherapy on clinical PFS in patients with high-risk localized prostate cancer (with a stringent selection of patients with at least 2 high-risk features), in a 2-by-2 factorial study. Men aged 18 to 75 years with stage T3 or T4 prostate cancer and a Gleason score ≥8 may be eligible for enrollment if other criteria are met. Patients will receive ADT plus pelvic radiotherapy, ADT plus cabazitaxel and prostate radiotherapy, ADT plus cabazitaxel and pelvic radiotherapy, or ADT plus prostate radiotherapy.

The primary outcome measure is PFS. The secondary outcome measures include PSA response at 3 months, biochemical PFS, metastases-free survival, local relapse-free survival, OS, prostate cancer–specific survival, acute toxicity, impact of treatment on serum testosterone, long-term toxicity, predictive biomarkers on treatment efficacy, and quality of life. This study plans to enroll 1048 patients at the Institut Gustave Roussy in Villejuif, France. For more information, contact Karim Fizazi, MD, PhD, at fizazi@igr.fr, or Pierre Blanchard at pierre.blanchard@gustaveroussy.fr. The NLM Identifier is NCT01952223.

8. ADT plus TAK-700 versus ADT plus Bicalutamide for Metastatic Prostate Cancer

This randomized, open-label, parallel-assignment, phase 3 study will compare OS in patients with newly diagnosed metastatic prostate cancer assigned to receive ADT plus TAK-700 versus ADT plus bicalutamide. Men aged ≥18 years with a clinical diagnosis of metastatic prostate cancer, Zubrod performance status of 0 to 2, and PSA ≥2 ng/mL may be eligible for enrollment if other criteria are met. Eligible patients will receive ADT plus TAK-700 or ADT plus bicalutamide.

The primary outcome measure is OS. This study expects to enroll 1486 patients at multiple locations across the United States. For more information, contact Jennifer I. Scott at 210-614-8808 ext 1007 or jscott@swog.org, or Dana B. Sparks at 210-614-8808 ext 1004 or dsparks@swog.org. The NLM Identifier is NCT01809691.

9. Alpha-Blocker Rapaflo to Treat Symptoms in Patients with Prostate Cancer Undergoing Radiation Therapy

Many patients undergoing radiation therapy have symptomatic urinary problems, which can significantly diminish patients’ quality of life during and shortly after therapy. This randomized, open-label, parallel-assignment, phase 3 clinical trial compares standard-of-care Rapaflo versus preventive treatment with Rapaflo in patients with prostate cancer—regardless of their risk—whose treatment comprises radical radiation therapy. Men aged ≥18 years with clinical or radiologic diagnosis of stage T1a to T3b prostate cancer and a Karnofsky performance score of ≥70 may be eligible for enrollment if other criteria are met. Eligible patients will receive Rapaflo on day 1 of radiation therapy before symptom onset and continue for 6 months (preventive Rapaflo therapy) or at the onset of symptomatic urinary problems caused by radiation therapy until symptoms disappear (standard Rapaflo therapy).

The primary outcome measure is the rate of increase and the mean difference from the baseline Inter­national Prostate Symptom Score (IPSS) with preventive Rapaflo versus standard Rapaflo. The secondary outcome measures include the rate of IPSS return to baseline and the rate of therapy dependence. This study plans to enroll 188 patients in Quebec, Canada. For more information, contact Karen Lai Wing Sun at 514-340-8222 ext 4785 or klaiwingsun@jgh.mcgill.ca, or Ravi A. Madan, MD, at 301-496-3493 or rm480i@nih.gov. The NLM Identifier is NCT02220829.

10. JNJ-56021927 (ARN-509) in Patients with High-Risk Prostate Cancer Receiving Primary Radiation Therapy: The ATLAS Study

The purpose of this randomized, double-blind, parallel-assignment, phase 3 study is to determine whether JNJ-56021927 plus gonadotropin-releasing hormone (GnRH) agonist in participants with high-risk, localized or locally advanced prostate cancer who receive primary radiation therapy that results in an improvement of metastasis-free survival. Men aged ≥18 years indicated and planned to receive primary radiation therapy for prostate cancer, with a Charlson Index ≤3 and an ECOG performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Participants will be randomized to receive JNJ-56021927 for 28 months plus bicalutamide placebo for 4 months from randomization, or bicalutamide for 4 months plus JNJ-56021927 placebo for 28 months from randomization. All participants will receive GnRH agonist for 28 months from randomization and radiation therapy to the prostate starting at approximately 8 weeks after randomization.

The primary outcome measure is metastasis-free survival. The secondary outcome measures include time to local-regional recurrence, time to CRPC, time to distant metastasis, and OS. This study expects to enroll 1500 patients at multiple locations across the United States and abroad. For more information, contact JNJ.CT@sylogent.com. The NLM Identifier is NCT02531516.

11. Extended Hypofractiona­tion Radiotherapy versus Accelerated Hypofrac­tionation Radiotherapy for Pros­tate Cancer: The HEAT Study

The purpose of this phase 3, randomized, open-label, parallel-group assignment clinical trial is to compare the safety and efficacy of accelerated hypofractionation radiotherapy with that of extended hypofractionation radiotherapy in patients with prostate cancer. Men aged 35 to 85 years with a Gleason score of 2 to 7 and a Zubroad performance status of 0 to 1 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive extended hypofractionation radiotherapy (70.2 Gy delivered in 26 fractions) or accelerated hypofractionation radiotherapy (36.25 Gy delivered in 5 fractions).

The primary outcome measure is the 2-year failure rate. The secondary outcome measures include acute toxicity rates, OS, quality of life, biochemical failure, rates of late-occurring grade ≥2 gastrointestinal or genitourinary toxicity, cost–benefit, and efficacy. This study expects to enroll 75 patients in Florida and Australia. For more information, contact Matthew C. Abramowitz, MD, at 305-243-4200 or mabramowitz@med.miami.edu. The NLM Identifier is NCT01794403.

Related Items
Select Ongoing Trials Currently Enrolling Patients with Scleroderma
Rheumatology Practice Management February 2018 Vol 6 No 1 published on February 16, 2018 in Clinical Trials Tracker
Select Ongoing Trials Currently Enrolling Patients with Juvenile Idiopathic Arthritis
Rheumatology Practice Management December 2017 Vol 5 No 6 published on January 8, 2018 in Clinical Trials Tracker
Select Ongoing Trials Currently Enrolling Patients with Lupus
Rheumatology Practice Management October 2017 Vol 5 No 5 published on October 20, 2017 in Clinical Trials Tracker
Select Ongoing Trials Currently Enrolling Patients with Rheumatoid Arthritis
Rheumatology Practice Management August 2017 Vol 5 No 4 published on August 16, 2017 in Clinical Trials Tracker
Select Ongoing Trials Currently Enrolling Patients with Fibromyalgia
Rheumatology Practice Management June 2017 Vol 5 No 3 published on June 28, 2017 in Clinical Trials Tracker
Select Ongoing Clinical Trials Currently Enrolling Patients with Osteoarthritis
Rheumatology Practice Management April 2017 Vol 5 No 2 published on April 25, 2017 in Clinical Trials Tracker
Select Ongoing Trials Currently Enrolling Patients with Psoriatic Arthritis
Rheumatology Practice Management February 2017 Vol 5 No 1 published on March 2, 2017 in Clinical Trials Tracker
Select Ongoing Clinical Trials Currently Enrolling Patients with Scleroderma
Rheumatology Practice Management December 2016 Vol 4 No 6 published on December 28, 2016 in Clinical Trials Tracker
Select Ongoing Trials Currently Enrolling Patients with Lupus
Rheumatology Practice Management October 2016 Vol 4 No 5 published on October 28, 2016 in Clinical Trials Tracker
Select Ongoing Clinical Trials Currently Enrolling Patients with Juvenile Idiopathic Arthritis
Rheumatology Practice Management August 2016 Vol 4 No 4 published on August 25, 2016 in Clinical Trials Tracker
Last modified: October 12, 2016
  • American Health and Drug Benefits
  • Association for Value Based Cancer Care
  • Lynx CME
  • Oncology Practice Management
  • Rheumatology Practice Management

Search