Prostate CarcinomaPhase 2α-RTNCT02484339
Treatment of Advanced Castration Resistant Prostate Carcinoma With Limited Bone Metastases (α-RT)
A Phase 2 study testing Radium-223 dichloride and Conventional or high dose radiotherapy in people with Prostate Carcinoma, run by University Hospital Freiburg at 6 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Prostate Carcinoma
- What is being tested?
- Radium-223 dichloride and Conventional or high dose radiotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 6 sitesGermany
- Study dates
- Dec 2014to Dec 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Patients with progressive castration resistant prostate cancer (CRPC) with 1-5 bone metastases for whom Radium-223 dichloride constitutes first-line cytostatic treatment
- Primary tumor (and its local recurrence, if applicable) controlled by effective local treatment
- If diagnosed, pelvic lymph node metastases controlled by effective local treatment
- 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
- Progressive disease is defined either by:
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- 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
- Life expectancy of at least 6 months.
- (WHO/ECOG) Performance Status (PS) 0 or 1
- 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:
- Patient has or has had symptoms (e. g. pain or micro)
Who cannot join
- Excluded medical conditions:
- More than 5 not previously locally treated bone metastases as diagnosed by bone scintigraphy;
- Visceral or lymph node metastases above the pelvis as assessed by computed tomography (CT) (or other imaging modality) ;
- History of HIV infection or chronic hepatitis B or C
- Active clinically serious infections (> grade 2 National Cancer Institute Common Terminology Criteria (NCI-CTC) version 4.03)
- History of organ allograft
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- Patients undergoing renal dialysis
- 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.
- Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
- Imminent or history of spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI)
- Any other serious illness or medical condition
- Fecal incontinence
- Any condition that is unstable or could jeopardize the safety of the patient and his compliance in the study
- Known allergy to Radium-223 dichloride (i.e. to active substance or one of the constituents)
- Excluded therapies and medications, previous and concomitant:
- Anticancer chemo- or targeted therapy for CRPC
- Radiotherapy for prostate cancer manifestations other than study treatment if not given with curative intent to prostate fossa and/or pelvic lymph nodes
- Major surgery within 4 weeks of study entry.
- Systemic therapy with radionuclides for the treatment of bone metastases
- Autologous bone marrow transplant or stem cell rescue within 4 months of study entry
- Use of biologic response modifiers, such as Granulocyte-Colony Stimulating Factor (G-CSF), within 3 week of study entry
- Investigational drug therapy outside of this trial during or within 4 weeks of study entry
Trial locations and contacts
6 sites in 1 country.
Ursula Nestle, Prof.Dr. contact
Daniel Schnell, Dr. contact
6 sites in 1 country
Germany6 sites, 6 recruiting
- Recruiting
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
Dresden, 01307
Tobias Hölscher, Dr, 0351 4580
Franziska Hessel, Dr, 0351 4580
- Recruiting
Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
Freiburg im Breisgau, 79106
Ursula Nestle, Prof.Dr., alpha-radiotherapy@uniklinik-freiburg.de
Daniel Schnell, Dr., alpha-radiotherapy@uniklinik-freiburg.de
- Recruiting
Universitätsmedizin Mainz, Klinik und Poliklinik für Nuklearmedizin
Mainz, 55131
Matthias Miederer, Prof., 06131 170
Mathias Schreckenberger, Prof., 06131 170
- Recruiting
Klinikum der Universität München
München, 81377
Ute Ganswindt, Prof, 089 / 4400-0
Minglun Li, Dr, 089 / 4400-0
- Recruiting
Universitätsklinikum Tübingen
Tübingen, 72076
Arndt Ch Müller, Prof, 07071 290
Daniel Zips, Prof, 07071 290
- Recruiting
Universitätsklinikum Würzburg
Würzburg, 97080
Andreas K Buck, Prof, 0931 2010
Ken Herrmann, PD, 0931 2010
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Carcinoma
- Being tested
- Radium-223 dichloride, Conventional or high dose radiotherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radium-223 dichlorideDrug
Also called Xofigo®
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.
Conventional or high dose radiotherapyOther
Also called External beam radiotherapy (EBRT)
Arm B: External beam radiotherapy (EBRT)->->conventional or high dose radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group A | Experimental | Radium-223 dichloride (Xofigo®) 55 kilobecquerel (kBq)/kgbw (6 i.v. injections every 4 weeks)
External beam radiotherapy (EBRT)->conventional or high dose radiotherapy Receives: Drug: Radium-223 dichloride; Other: Conventional or high dose radiotherapy |
| Treatment Group B | Other | External beam radiotherapy (EBRT) ->conventional or high dose radiotherapy Receives: Other: Conventional or high dose radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to radiological progression free survival (PFS) rate
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
Measured: randomization to radiological progression
Secondary outcomes (8)
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
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
Measured: Time to local progression in any of the EBRT treated bone metastases
Overall survival
Follow up every 3 month until month 24 and after that in long term follow up every 6 month
Measured: randomization to death
Time to distant bone metastasis progression outside the RT target volumes
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
Measured: Screening to FU 7 (after 24 months) and than in long term follow up every 6 month
Time to Skeletal Related Event (SRE)
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
Measured: Screening to FU 7 (after 24 months) and than in long term follow up every 6 month
Pain control
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
Measured: 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
Follow up every 3 month until month 24 measured by RECIST criteria and than in long term follow up every 6 month
Measured: 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
Follow up every 3 month until month 24 and after that long term follow up every 6 month measured by PSA level
Measured: 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
Follow up every 3 month until month 24 and than long term follow up every 6 month measured by blood level
Measured: Screening to FU 7 (after 24 months) and than in long term follow up every 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CarcinomaStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 274 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Ursula Nestle, University Hospital Freiburg
- Investigators
- Ursula Nestle, Principal investigator, University Hospital Freiburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02484339
- Sponsor's protocol ID
- α-RT
- Acronym
- α-RT
- Status last verified
- Apr 2016
- First submitted
- 13 May 2015
- Last updated
- 27 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02484339
- Acronym / sponsor ID
- α-RT / α-RT
- Conditions
- Prostate Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 274 participants (estimated)
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 29 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group A | Experimental | Drug: Radium-223 dichloride, Other: Conventional or high dose radiotherapyRadium-223 dichloride (Xofigo®) 55 kilobecquerel (kBq)/kgbw (6 i.v. injections every 4 weeks) External beam radiotherapy (EBRT)->conventional or high dose radiotherapy |
| Treatment Group B | Other | Other: Conventional or high dose radiotherapyExternal beam radiotherapy (EBRT) ->conventional or high dose radiotherapy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
- Patients with progressive castration resistant prostate cancer (CRPC) with 1-5 bone metastases for whom Radium-223 dichloride constitutes first-line cytostatic treatment
- Primary tumor (and its local recurrence, if applicable) controlled by effective local treatment
- If diagnosed, pelvic lymph node metastases controlled by effective local treatment
- 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
Key exclusion criteria (22 listed)
- More than 5 not previously locally treated bone metastases as diagnosed by bone scintigraphy;
- Visceral or lymph node metastases above the pelvis as assessed by computed tomography (CT) (or other imaging modality) ;
- History of HIV infection or chronic hepatitis B or C
- Active clinically serious infections (> grade 2 National Cancer Institute Common Terminology Criteria (NCI-CTC) version 4.03)
- History of organ allograft
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 |
|---|---|---|
| Radium-223 dichlorideAlso: Xofigo®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. | Drug | Treatment Group A |
| Conventional or high dose radiotherapyAlso: External beam radiotherapy (EBRT)Arm B: External beam radiotherapy (EBRT)->->conventional or high dose radiotherapy | Other | Treatment Group A, Treatment Group B |
Primary outcome
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
8 secondary outcomes
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
Overall survival
Time frame: 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
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
Pain control
Time frame: 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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2016.
- Individual participant dataSharing planned: No
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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.
Ursula Nestle, Prof.Dr. contact
Daniel Schnell, Dr. contact
Ursula Nestle principal investigator
University Hospital Freiburg, Germany
6 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 Radium-223 dichloride and Conventional or high dose radiotherapy in people with Prostate Carcinoma, run by University Hospital Freiburg at 6 sites in Germany.
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 12 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 27 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ursula Nestle, Prof.Dr. (alpha-radiotherapy@uniklinik-freiburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to radiological progression free survival (PFS) rate (time frame: randomization to radiological progression). 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 27 Apr 2016.