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

NCT02484339 | Unknown Phase 2 DMC

• 1 other identifier: α-RT
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 6

Brief 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. 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.

Conditions

Prostate Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

  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

  Time to local progression in any of the EBRT treated bone metastases

• Overall survival

  randomization to death

• Time to distant bone metastasis progression outside the RT target volumes

  Screening to FU 7 (after 24 months) and than in long term follow up every 6 month

• Time to Skeletal Related Event (SRE)

  Screening to FU 7 (after 24 months) and than in long term follow up every 6 month

• Pain control

  Screening to FU 7 (after 24 months) and than in long term follow up every 6 month

Study Arms (2)

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

Drug: Radium-223 dichloride; Other: Conventional or high dose radiotherapy

Treatment Group B

OTHER

External beam radiotherapy (EBRT) -\>conventional or high dose radiotherapy

Other: Conventional or high dose radiotherapy

Interventions

Radium-223 dichloride DRUG

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.

Also known as: Xofigo®

Treatment Group A

Conventional or high dose radiotherapy OTHER

Arm B: External beam radiotherapy (EBRT)-\>-\>conventional or high dose radiotherapy

Also known as: External beam radiotherapy (EBRT)

Treatment Group A; Treatment Group B

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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)

You may not qualify if:

• 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
• 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:

Sponsors & Collaborators

• University Hospital Freiburg: lead

Study Sites (6)

Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

Dresden, 01307, Germany

RECRUITING

Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde

Freiburg im Breisgau, 79106, Germany

RECRUITING

Universitätsmedizin Mainz, Klinik und Poliklinik für Nuklearmedizin

Mainz, 55131, Germany

RECRUITING

Klinikum der Universität München

München, 81377, Germany

RECRUITING

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

RECRUITING

Universitätsklinikum Würzburg

Würzburg, 97080, Germany

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

radium Ra 223 dichloride; Congresses as Topic; Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations; Therapeutics

Study Officials

• Ursula Nestle

  University Hospital Freiburg, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ursula Nestle, Prof.Dr.

CONTACT

alpha-radiotherapy@uniklinik-freiburg.de

Daniel Schnell, Dr.

CONTACT

alpha-radiotherapy@uniklinik-freiburg.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr. med

Study Record Dates

• First Submitted: May 13, 2015
• First Posted: June 29, 2015
• Study Start: December 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: April 27, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (6)