Treatment of Advanced Castration Resistant Prostate Carcinoma With Limited Bone Metastases (α-RT) (α-RT)

April 26, 2016 updated by: Prof. Dr. Ursula Nestle, University Hospital Freiburg

Phase II Open-label Study to Evaluate the Efficacy and Safety of Radium in Combination With External Beam Radiotherapy (EBRT) vs. EBRT Alone in the Treatment of Castration Resistant Prostate Carcinoma With Limited Bone Metastases

Phase II open-label study to evaluate the efficacy and safety of Radium-223 dichloride in combination with external beam radiotherapy (EBRT) vs. external beam radiotherapy alone in the treatment of advanced castration resistant prostate carcinoma with limited bone metastases.

To evaluate if time to radiological progression according to the "Recommendations of the Prostate Cancer Clinical Trials Working Group" published by Scher et al. (JCO 2008) (based on new lesions in bone scan and CT /MRI or death) of Radium-223 dichloride combined with EBRT is superior compared to EBRT alone.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is an international, multi-center, open-label, prospective, phase II study designed to assess the efficacy of radiation therapy in combination with Radium-223 dichloride in patients diagnosed with CRPC and oligo metastases bone disease. All patients enrolled in this study will have signed an informed consent form (ICF) and will adhere to all inclusion and exclusion criteria.

During the treatment period, patients will be followed on an ongoing basis for safety and quality of life (QoL). Safety assessments will include the collection of all AEs of any grade, serious adverse events (SAEs), adverse event (AEs) corresponding to symptoms arising from bone metastases, laboratory values, (WHO/ECOG) performance status (PS). Documentation of the date of disease progression will be performed at intervals and imaging methods (bone scans and CR/MRI) described in the study protocol. Quality of life will be measured by patient assessment using a validated questionnaire, the Brief Pain Inventory Short Form (BPI-SF), the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C15-PAL and the EORTC QLQ- Bone Metastases (BM) 22. Follow-up assessments for safety AEs and SAEs, and the occurrence of secondary malignancies will be conducted every 3-12 months until the patient dies or until the study is terminated by the sponsor. If the patient can no longer travel to the clinical site, he will be followed up for survival only, i.e., the long term follow-up phase of the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
274

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
      • Dresden, Germany, 01307
        • Recruiting
        • Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
        • Contact:
          • Tobias Hölscher, Dr
          • Phone Number: 0351 4580
        • Contact:
          • Franziska Hessel, Dr
          • Phone Number: 0351 4580
      • Freiburg, Germany, 79106
      • Mainz, Germany, 55131
        • Recruiting
        • Universitätsmedizin Mainz, Klinik und Poliklinik für Nuklearmedizin
        • Contact:
          • Matthias Miederer, Prof.
          • Phone Number: 06131 170
        • Contact:
          • Mathias Schreckenberger, Prof.
          • Phone Number: 06131 170
        • Sub-Investigator:
          • Eva Holzhäuser, Dr.med
      • München, Germany, 81377
        • Recruiting
        • Klinikum der Universitat Munchen
        • Contact:
          • Ute Ganswindt, Prof
          • Phone Number: 089 / 4400-0
        • Contact:
          • Minglun Li, Dr
          • Phone Number: 089 / 4400-0
        • Sub-Investigator:
          • Harun Illhan, Dr
      • Tübingen, Germany, 72076
        • Recruiting
        • Universitätsklinikum Tübingen
        • Contact:
          • Arndt Ch Müller, Prof
          • Phone Number: 07071 290
        • Contact:
          • Daniel Zips, Prof
          • Phone Number: 07071 290
        • Sub-Investigator:
          • Helmut Dittmann, Dr
      • Würzburg, Germany, 97080
        • Recruiting
        • Universitatsklinikum Wurzburg
        • Contact:
          • Andreas K Buck, Prof
          • Phone Number: 0931 2010
        • Contact:
          • Ken Herrmann, PD
          • Phone Number: 0931 2010
        • Sub-Investigator:
          • Michaela Metz, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Has provided written informed consent. Subjects must be able to understand and be willing to sign the written informed consent form (ICF). Age ≥ 18 and ≤ 85 years
  2. Patients with progressive castration resistant prostate cancer (CRPC) with 1-5 bone metastases for whom Radium-223 dichloride constitutes first-line cytostatic treatment
  3. Primary tumor (and its local recurrence, if applicable) controlled by effective local treatment
  4. If diagnosed, pelvic lymph node metastases controlled by effective local treatment
  5. At least 1 not previously locally treated skeletal metastasis on bone scan without non-bone distant metastases (e.g. lung, liver, and/or brain metastases) and without pathologically enlarged lymph nodes above the pelvis

  6. Progressive disease is defined either by:

    • The appearance of new bone lesions. If progression is based on new lesion(s) on bone scan only without an increase in prostate specific antigen (PSA), PSA values from 3 assessments within the last 6 months must be provided; OR
    • In the absence of new bone lesions by 2 consecutive increases in serum PSA over previous reference value, which should not be more than 6 months before screening, each measured at least 1 week apart with the last PSA ≥5 ng/mL
  7. Life expectancy of at least 6 months.
  8. (WHO/ECOG) Performance Status (PS) 0 or 1
  9. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to start of therapy:
  10. Patient has or has had symptoms (e. g. pain or micro)

Exclusion Criteria:

Excluded medical conditions:

  1. More than 5 not previously locally treated bone metastases as diagnosed by bone scintigraphy;
  2. Visceral or lymph node metastases above the pelvis as assessed by computed tomography (CT) (or other imaging modality) ;
  3. History of HIV infection or chronic hepatitis B or C
  4. Active clinically serious infections (> grade 2 National Cancer Institute Common Terminology Criteria (NCI-CTC) version 4.03)
  5. History of organ allograft
  6. Patients undergoing renal dialysis
  7. Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study if not in complete remission for at least 5 years since date of diagnosis treated treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry.
  8. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
  9. Imminent or history of spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI)
  10. Any other serious illness or medical condition
  11. Fecal incontinence
  12. Any condition that is unstable or could jeopardize the safety of the patient and his compliance in the study
  13. Known allergy to Radium-223 dichloride (i.e. to active substance or one of the constituents)

Excluded therapies and medications, previous and concomitant:

  1. Anticancer chemo- or targeted therapy for CRPC
  2. Radiotherapy for prostate cancer manifestations other than study treatment if not given with curative intent to prostate fossa and/or pelvic lymph nodes
  3. Major surgery within 4 weeks of study entry.
  4. Systemic therapy with radionuclides for the treatment of bone metastases
  5. Autologous bone marrow transplant or stem cell rescue within 4 months of study entry
  6. Use of biologic response modifiers, such as Granulocyte-Colony Stimulating Factor (G-CSF), within 3 week of study entry
  7. Investigational drug therapy outside of this trial during or within 4 weeks of study entry

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment Group A

Radium-223 dichloride (Xofigo®) 55 kilobecquerel (kBq)/kgbw (6 i.v. injections every 4 weeks)

External beam radiotherapy (EBRT)->conventional or high dose radiotherapy
Drug: Radium-223 dichloride
Arm A: EBRT and timely sequential start with Radium-223 dichloride 55 kBq/kgbw (6 i.v. injections every 4 weeks) and best supportive care until progression or intolerable toxicity.
Other Names:
  • Xofigo®
Other: Conventional or high dose radiotherapy
Arm B: External beam radiotherapy (EBRT)->->conventional or high dose radiotherapy
Other Names:
  • External beam radiotherapy (EBRT)
Other: Treatment Group B
External beam radiotherapy (EBRT) ->conventional or high dose radiotherapy
Other: Conventional or high dose radiotherapy
Arm B: External beam radiotherapy (EBRT)->->conventional or high dose radiotherapy
Other Names:
  • External beam radiotherapy (EBRT)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to radiological progression free survival (PFS) rate
Time Frame: randomization to radiological progression
measured every 3 month by Bone Scan and MRI or CT until Follow up 7 (month 24) and after that in long term follow up every 6 month
randomization to radiological progression

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to local progression in any of the EBRT treated bone metastases of conventional radiotherapy (CRT) vs. High-dose image-based conformal radiotherapy (HIRT) treatment techniques
Time Frame: Time to local progression in any of the EBRT treated bone metastases
measured every 3 month by Bone Scan, Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) until month 24 after that in long term follow up every 6 month with open end
Time to local progression in any of the EBRT treated bone metastases
Overall survival
Time Frame: randomization to death
Follow up every 3 month until month 24 and after that in long term follow up every 6 month
randomization to death
Time to distant bone metastasis progression outside the RT target volumes
Time Frame: Screening to FU 7 (after 24 months) and than in long term follow up every 6 month
Follow up every 3 month until month 24 and than in long term follow up every 6 month measured by increasing of PSA, CT/MRI
Screening to FU 7 (after 24 months) and than in long term follow up every 6 month
Time to Skeletal Related Event (SRE)
Time Frame: Screening to FU 7 (after 24 months) and than in long term follow up every 6 month
measured every 3 month by Bone Scan, Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) until month 24 and than in long term follow up every 6 month with open end
Screening to FU 7 (after 24 months) and than in long term follow up every 6 month
Pain control
Time Frame: Screening to FU 7 (after 24 months) and than in long term follow up every 6 month
measured every 3 month by the Brief Pain Inventory Short Form (BPI-SF), the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C15-PAL and the EORTC QLQ- Bone Metastases (BM) 22 until month 24 and than in long term follow up every 6 month
Screening to FU 7 (after 24 months) and than in long term follow up every 6 month
Disease Control Rate (DCR); Response rates according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Time Frame: Screening to FU 7 (after 24 months) and than in long term follow up every 6 month
Follow up every 3 month until month 24 measured by RECIST criteria and than in long term follow up every 6 month
Screening to FU 7 (after 24 months) and than in long term follow up every 6 month
PSA response, time to PSA response and time to PSA normalization
Time Frame: Screening to FU 7 (after 24 months) and than in long term follow up every 6 month
Follow up every 3 month until month 24 and after that long term follow up every 6 month measured by PSA level
Screening to FU 7 (after 24 months) and than in long term follow up every 6 month
Bone alkaline phosphatase (ALP) response, time to bone ALP response
Time Frame: Screening to FU 7 (after 24 months) and than in long term follow up every 6 month
Follow up every 3 month until month 24 and than long term follow up every 6 month measured by blood level
Screening to FU 7 (after 24 months) and than in long term follow up every 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital Freiburg

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ursula Nestle, University Hospital Freiburg, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • α-RT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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