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RAdium-223 and SABR Versus SABR for Oligometastatic Prostate Cancers (RAVENS)

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ClinicalTrials.gov Identifier: NCT04037358
Recruitment Status : Recruiting
First Posted : July 30, 2019
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:
This is a Phase II non-blinded randomized study evaluating men with oligometastatic prostate cancer lesions randomized (1:1) to stereotactic ablative radiation therapy (SABR) versus SBAR + Radium-223. We are looking to determine the progression-free survival of men who have oligometastatic prostate cancer with at least one bone metastasis with stereotactic ablative radiation therapy (SABR) versus SABR + Radium-223.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Radium-223 Radiation: stereotactic ablative radiotherapy (SABR) Phase 2

Detailed Description:
The metastatic capacity of prostate cancer (PCa) behaves along a spectrum of disease that contains an oligometastatic state where metastases are limited in number and location. The importance of local consolidation of all tumor deposits in oligometastatic disease to forestall further metastatic dissemination is now backed by small randomized studies. Our previous Baltimore ORIOLE randomized trial of stereotactic ablative radiation (SABR) alone, highly focused, high-dose radiation, versus observation in oligometastatic PCa final data demonstrate a progression-free survival (PFS) benefit of SABR alone. The patterns of failure from our ORIOLE trial in combination with prior data suggest one dominant mode of failure is from microscopic disease particularly those with bone-tropic biology. These are important early clinical data suggesting the existence of an oligometastatic state and the importance of local therapies in the management of these patients. Radiopharmaceutical therapy (RPT) approaches have not been applied in the oligometastatic space and thus the opportunity to target micrometastatic disease in conjunction with local consolidation of macroscopic disease with SABR has the potential to provide a curative paradigm for patients with oligometastatic PCa. We introduce the successor trial to ORIOLE called RAVENS that is a phase II randomized trial of SABR +/- the bone metastasis seeking RPT Xofigo in men with oligometastatic PCa. We hypothesize macroscopic prostate tumors support the growth of and help nurture future distant metastases and this process can be impacted most by total, macro- and microscopic, tumor consolidation. In addition, we hypothesize that circulating biomarkers can identify men with oligometastasis that benefit the most from SABR and RPT.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: RAdium-223 and SABR Versus SABR (Stereotactic Ablative Radiotherapy)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Randomized Trial of RAdium-223 and SABR Versus SABR for oligomEtastatic Prostate caNcerS (RAVENS)
Actual Study Start Date : August 9, 2019
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : August 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Radium-223 and SABR
First radium-223 infusion will be within two weeks of SABR
Drug: Radium-223
Radium-223 plus SABR will be within two weeks.

Radiation: stereotactic ablative radiotherapy (SABR)
SABR 1-5 fractions

Active Comparator: SABR
SABR(1-5 fractions) will be administered for all men
Radiation: stereotactic ablative radiotherapy (SABR)
SABR 1-5 fractions




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 12 months ]
    Time to progression in men who have oligometastatic prostate cancer after therapy. Progression is defined by PCWG2 criteria as follows: >=25% increase in PSA from nadir (and by >=2ng/mL), and/or clinical/radiographic progression (clinical progression = symptomatic progression, worsening of disease-related symptoms or new cancer-related complications; radiographic progression on CT scan defined by RECIST 1.1 criteria: >=20% enlargement in sum diameter of soft-tissue target lesions; or on bone scan >=1 new bone lesions), initiation of ADT or death due to any cause, whichever occurs first.


Secondary Outcome Measures :
  1. Toxicity as assessed by number of participants who experience adverse events [ Time Frame: 12 months ]
    Number of participants who receive at least one fraction of SABR and Radium-223 who experience adverse events as defined by CTCAE v4.0 after first treatment of SABR and Radium-223.

  2. Local control at 12 months [ Time Frame: 12 months ]
    Time from starting treatment until local relapse is documented

  3. Time to locoregional progression [ Time Frame: 12 months ]
    Time from starting treatment until local and/or regional relapse is documented

  4. Time to distant progression [ Time Frame: 12 months ]
    Time from starting treatment until distant relapse is documented

  5. Time to new metastasis [ Time Frame: 12 months ]
    time from starting treatment to the time of a new documented tumor metastasis by CT and/or bone scan. Subjects who do not progress will be censored at the time of the last contact.

  6. ADT-free survival [ Time Frame: 12 months ]
    Time from randomization until initiation of androgen-deprivation therapy (ADT).

  7. Quality of Life as assessed by Pain Severity and Pain Interference using the Brief Pain Inventory [ Time Frame: 12 months ]
    The brief pain inventory assesses the severity of pain, location of pain, amount of pain over the last 24 hours, and impact of pain on daily functions. Scores for the 4 pain severity items and 7 pain interference items range from 0-10, where 10 is the worst pain or pain that completely interferes with described activity and 0 is the least pain or does not interfere with described activity. The mean of these scores is used to measure pain severity and pain interference.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient must have at least one and up to three asymptomatic metastatic tumor(s) of the bone or soft tissue (with at least one bone metastasis) develop within the past 6-months that are ≤ 5.0 cm or <250 cm3
  • Patient must have had their primary tumor treated with surgery and/or radiation.
  • Histologic confirmation of malignancy (primary or metastatic tumor).
  • PSADT <15 months. PSA doubling time (PSADT) will be calculated using as many PSA values that are available from time of relapse (PSA > 0.2). To calculate PSADT, the Memorial Sloan Kettering Cancer Center Prostate Cancer Prediction Tool will be used. It can be found at the following web site: https://www.mskcc.org/nomograms/prostate/psa-doubling-time.
  • Patient may have had prior systemic therapy and/or ADT associated with treatment of their primary prostate cancer. Patient may have had ADT associated with salvage radiation therapy (to the primary prostate cancer or pelvis is allowed).
  • PSA > 0.5 but <50.
  • Testosterone > 125 ng/dL.
  • Patient must be ≥ 18 years of age.
  • Patient must have a life expectancy ≥ 12 months.
  • Patient must have an ECOG performance status ≤ 2.
  • Patient must have normal organ and marrow function as defined as:

Before the first administration of Xofigo, the absolute neutrophil count (ANC) should be ≥ 1.5 x 109/L, the platelet count ≥ 100 x 109/L and hemoglobin ≥ 10 g/dL.

* Patient must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • No more than 3 years of ADT is allowed, with the most recent ADT treatment having occurred greater than 6 months prior to enrollment.
  • PSMA-PET/MRI or PSMA-PET/CT scan within the past 6 months with results that demonstrate more disease lesions than baseline CT/Bone Scan
  • Castration-resistant prostate cancer (CRPC).
  • Spinal cord compression or impending spinal cord compression.
  • Suspected pulmonary and/or liver metastases (greater >10 mm in largest axis).
  • Patient receiving any other investigational agents.
  • Patient receiving abiraterone and prednisone.
  • Patient is participating in a concurrent treatment protocol.
  • Serum creatinine > 3 times the upper limit of normal.
  • Total bilirubin > 3 times the upper limit of normal.
  • Liver Transaminases > 5-times the upper limit of normal.
  • Unable to lie flat during or tolerate PET/MRI, PET/CT or SBRT.
  • Prior salvage treatment to the primary prostate cancer or pelvis is allowed.
  • Refusal to sign informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04037358


Contacts
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Contact: Phuoc Tran, M.D., Ph.D. 410-614-3880 tranp@jhmi.edu
Contact: Hamza Hasan 410-955-8652 hhasan@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21287
Contact: Phuoc Tran, M.D., Ph.D.    410-614-3880    tranp@jhmi.edu   
Contact: Hamza Hasan    410-955-8652    hhasan@jhmi.edu   
Sub-Investigator: Theodore DeWeese, M.D.         
Sub-Investigator: Danny Song, M.D.         
Sub-Investigator: Mario Eisenberger, M.D.         
Sub-Investigator: Michael Gorin, M.D.         
Sub-Investigator: Emmanuel Antonarakis, M.D.         
Sub-Investigator: Mark Markowski, M.D.         
Sub-Investigator: Samuel Denmeade, M.D.         
Sub-Investigator: Channing Paller, M.D.         
Sub-Investigator: Kenneth Pienta, M.D.         
Sub-Investigator: Steve Rowe, M.D.         
Sub-Investigator: Martin Pomper, M.D         
Sub-Investigator: Stephen Greco, M.D.         
Sub-Investigator: Curtiland Deville, M.D.         
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Investigators
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Principal Investigator: Phuoc Tran, M.D., Ph.D. Johns Hopkins SKCCC

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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT04037358     History of Changes
Other Study ID Numbers: J18147
IRB00188450 ( Other Identifier: JHM IRB )
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases