Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer (VISION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03511664
Recruitment Status : Active, not recruiting
First Posted : April 30, 2018
Last Update Posted : August 27, 2019
Sponsor:
Information provided by (Responsible Party):
Endocyte

Brief Summary:

The primary objective of this study is to compare overall survival (OS) in patients with progressive PSMA-positive mCRPC who receive 177Lu-PSMA-617 in addition to best supportive/best standard of care versus patients treated with best supportive/best standard of care alone.

Key secondary objectives are an arm-to-arm comparison of the following:

  • Radiographic progression-free survival (rPFS)
  • Response Evaluation Criteria in Solid Tumors (RECIST) response
  • Time to a first symptomatic skeletal event (SSE)

Additional Secondary Objectives:

  • Safety and tolerability of 177Lu-PSMA-617
  • Health-related quality of life (HRQoL; EQ-5D-5L, FACT-P and Brief Pain Inventory - Short Form (BPI-SF))
  • Health economics
  • Progression-free survival (PFS) (radiographic, clinical, or prostate-specific antigen [PSA] progression-free survival)
  • Biochemical response as measured by PSA. Alkaline phosphatase [ALP] levels and lactate dehydrogenase [LDH] levels will also be measured.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: 177Lu-PSMA-617 Other: Best supportive/best standard of care Phase 3

Detailed Description:

Patients with PSMA positive scans will be randomized in a 2:1 ratio to receive either 177Lu-PSMA-617 plus best supportive/best standard of care or to receive best supportive/best standard of care only. Best supportive/best standard of care will be determined by the treating physician/investigator but will exclude investigational agents, cytotoxic chemotherapy, other systemic radioisotopes, and hemi-body radiotherapy. Novel androgen axis drugs [NAADs] (such as abiraterone or enzalutamide) are allowed.

The study is open-label and patients will be monitored throughout the 6 to 10-month treatment period for survival, disease progression, and adverse events.

A long-term follow-up period will include the collection of survival and treatment updates, adverse events assessment, as well as blood for hematology and chemistry testing. During follow-up, patients will be contacted every 3 months (±1 month) via phone, email, or letter for 24 months or until the the overall censoring rate for survival reduces to a level identified in the SAP.

An End of Treatment visit should occur once a patient is to enter the long term follow up. This visit should occur approximately 30 days from the last dose of 177Lu-PSMA-617 or best supportive/best standard of care, but before the initiation of subsequent anti-cancer treatment, outside of what is allowed on study.

The planned enrollment for this study is 750 patients.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study population includes patients with progressive PSMA-positive mCRPC who received at least one novel androgen axis drug [NAAD] (such as enzalutamide or abiraterone) and were previously treated with 1 to 2 taxane regimens. Patients treated with only 1 prior taxane regimen are eligible if the patient is unwilling or the patient's physician deems the patient unsuitable to receive a second regimen.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: VISION: An International, Prospective, Open Label, Multicenter, Randomized Phase 3 Study of 177Lu-PSMA-617 in the Treatment of Patients With Progressive PSMA-positive Metastatic Castration-resistant Prostate Cancer (mCRPC)
Actual Study Start Date : May 23, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: 177Lu-PSMA-617 plus BS/BSC
Patients randomized to receive the investigational product will receive 7.4 GBq (±10%) 177Lu-PSMA-617 intravenously every 6 weeks (±1 week) for a maximum of 6 cycles. + Best supportive/best standard of care (BS/BSOC)
Drug: 177Lu-PSMA-617
Patients randomized to receive the investigational product will receive 7.4 GBq (±10%) 177Lu-PSMA-617 intravenously every 6 weeks (±1 week) for a maximum of 6 cycles. After 4 cycles, patients will be assessed for (1) evidence of response, (2) residual disease, and (3) tolerance to 177Lu-PSMA-617. If all 3 assessments are met the patient may receive an additional 2 cycles of 177Lu-PSMA-617.

Other: Best supportive/best standard of care
Best supportive/best standard of care as defined by the local investigator
Other Name: Comparator

BS/BSC alone
Patients randomized to this arm will receive best supportive/best standard of care (BS/BSOC) as determined by the investigator
Other: Best supportive/best standard of care
Best supportive/best standard of care as defined by the local investigator
Other Name: Comparator




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: Every 6-8 weeks until end of treatment and every 3 months during long term follow up [up to 24 months ]
    Overall survival (OS) in patients with progressive PSMA-positive mCRPC who receive 177Lu-PSMA-617 in addition to best supportive/standard of care



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Prostate cancer
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must have the ability to understand and sign an approved ICF.
  2. Patients must have the ability to understand and comply with all protocol requirements.
  3. Patients must be ≥18 years of age.
  4. Patients must have an ECOG performance status of 0 to 2.
  5. Patients must have a life expectancy >6 months.
  6. Patients must have histological, pathological, and/or cytological confirmation of prostate cancer.
  7. Patients must be 68Ga-PSMA-11 PET/CT scan positive, and eligible as determined by the sponsor's central reader.
  8. Patients must have a castrate level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L).
  9. Patients must have received at least one NAAD (such as enzalutamide and/or abiraterone).
  10. Patients must have been previously treated with at least 1, but no more than 2 previous taxane regimens. A taxane regimen is defined as a minimum exposure of 2 cycles of a taxane. If a patient has received only 1 taxane regimen, the patient is eligible if:

    a. The patient's physician deems him unsuitable to receive a second taxane regimen (e.g. frailty assessed by geriatric or health status evaluation, intolerance, etc.).

  11. Patients must have progressive mCRPC. Documented progressive mCRPC will be based on at least 1 of the following criteria:

    1. Serum/plasma PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal start value is 2.0 ng/mL.
    2. Soft-tissue progression defined as an increase ≥20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of one or more new lesions.
    3. Progression of bone disease: evaluable disease or new bone lesions(s) by bone scan (2+2 PCWG3 criteria, Scher et al 2016).
  12. Patients must have ≥1 metastatic lesion that is present on baseline CT, MRI, or bone scan imaging obtained ≤28 days prior to beginning study therapy.
  13. Patients must have recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapies (i.e. prior chemotherapy, radiation, immunotherapy, etc.).
  14. Patients must have adequate organ function:

    a. Bone marrow reserve:

    • White blood cell (WBC) count ≥2.5 x 10^9/L (2.5 x 10^9/L is equivalent to 2.5 x 10^3/μL and 2.5 x K/μL and 2.5 x 10^3/cumm and 2500/μL) OR absolute neutrophil count (ANC) ≥1.5 x 10^9/L (1.5 x 10^9/L is equivalent to 1.5 x 10^3/μL and 1.5 x K/μL and 1.5 x 10^3/cumm and 1500/μL)
    • Platelets ≥100 x 10^9/L (100 x 10^9/L is equivalent to 100 x 10^3/μL and 100 x K/μL and 100 x 10^3/cumm and 100,000/μL)
    • Hemoglobin ≥9 g/dL (9 g/dL is equivalent to 90 g/L and 5.59 mmol/L) b. Hepatic:
    • Total bilirubin ≤1.5 x the institutional upper limit of normal (ULN). For patients with known Gilbert's Syndrome ≤3 x ULN is permitted
    • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3.0 x ULN OR ≤5.0 x ULN for patients with liver metastases c. Renal:
    • Serum/plasma creatinine ≤1.5 x ULN or creatinine clearance ≥50 mL/min
  15. Albumin >3.0 g/dL (3.0 g/dL is equivalent to 30 g/L) [Inclusion #16 has been removed]

17. HIV-infected patients who are healthy and have a low risk of AIDS-related outcomes are included in this trial. 18. For patients who have partners of childbearing potential: Partner and/or patient must use a method of birth control with adequate barrier protection, deemed acceptable by the principle investigator during the study and for 6 months after last study drug administration. 19. The best standard of care/ best supportive care options planned for this patient:

  1. Are allowed by the protocol
  2. Have been agreed to by the treating investigator and patient
  3. Allow for the management of the patient without 177Lu-PSMA-617

Exclusion Criteria:

  1. Previous treatment with any of the following within 6 months of randomization:

    Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation. Previous PSMA-targeted radioligand therapy is not allowed.

  2. Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy [including monoclonal antibodies]) within 28 days prior to day of randomization.
  3. Any investigational agents within 28 days prior to day of randomization.
  4. Known hypersensitivity to the components of the study therapy or its analogs.
  5. Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.
  6. Transfusion for the sole purpose of making a subject eligible for study inclusion.
  7. Patients with a history of CNS metastases must have received therapy (surgery, radiotherapy, gamma knife) and be neurologically stable, asymptomatic, and not receiving corticosteroids for the purposes of maintaining neurologic integrity. Patients with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired. For patients with parenchymal CNS metastasis (or a history of CNS metastasis), baseline and subsequent radiological imaging must include evaluation of the brain (MRI preferred or CT with contrast).
  8. A superscan as seen in the baseline bone scan.
  9. Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression.
  10. Concurrent serious (as determined by the Principal Investigator) medical conditions, including, but not limited to, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, known active hepatitis B or C, or other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation.
  11. Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, patients with a prior history of malignancy that has been adequately treated and who have been disease free for more than 3 years are eligible, as are patients with adequately treated non-melanoma skin cancer, superficial bladder cancer.

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): NCT03511664


  Hide Study Locations
Locations
Layout table for location information
United States, Arizona
HonorHealth Institute
Scottsdale, Arizona, United States, 85258
University of Arizona Cancer Center
Tucson, Arizona, United States, 85719-1454
United States, California
VA Greater Los Angeles Healthcare System
Los Angeles, California, United States, 90073
UCLA
Los Angeles, California, United States, 90095-7370
Stanford University
Palo Alto, California, United States, 94304
UCSF Medical Center at Mission Bay
San Francisco, California, United States, 94158
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale Cancer Center, Clinical Trials Office
New Haven, Connecticut, United States, 06519
United States, District of Columbia
Washington DC VA Medical Center, Nuclear Medicine Service
Washington, District of Columbia, United States, 20422
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Indiana
Parkview Cancer Institute
Fort Wayne, Indiana, United States, 46845
IU Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa Hospitals and Clinics Cancer Center Research
Iowa City, Iowa, United States, 52242
Iowa VA Medical Center
Iowa City, Iowa, United States, 52246
United States, Kentucky
Norton Cancer Institute
Louisville, Kentucky, United States, 40207
United States, Louisiana
Tulane Cancer Center
New Orleans, Louisiana, United States, 70112
United States, Maryland
University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States, 21201
Chesapeake Urology Research Associates
Towson, Maryland, United States, 21204
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
The Lank Center for Genitourinary Oncology
Boston, Massachusetts, United States, 02215
United States, Michigan
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48105
University of Michigan Medical Center, Division of Nuclear Medicine
Ann Arbor, Michigan, United States, 48109
Karmanos Cancer Center
Detroit, Michigan, United States, 48201
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
John Cochran St. Louis Veterans Medical Center
Saint Louis, Missouri, United States, 63106
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110-1093
St. Louis University Hospital
Saint Louis, Missouri, United States, 63110
United States, Nebraska
GU Research Network/ Urology Cancer Center
Omaha, Nebraska, United States, 68130
United States, Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89148
United States, New Jersey
Regional Cancer Care Associates
East Brunswick, New Jersey, United States, 08816
United States, New Mexico
New Mexico Oncology & Hematology Consultants
Albuquerque, New Mexico, United States, 87109
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
New York Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, United States, 10065
United States, North Carolina
Duke University School of Medicine, Duke Cancer Institute
Durham, North Carolina, United States, 27710
United States, Ohio
Precision Cancer Research/ Dayton Physicians Network
Kettering, Ohio, United States, 45409
United States, Oregon
Oregon Health and Science University Nuclear Medicine Department
Portland, Oregon, United States, 97239-3098
United States, Pennsylvania
Gettysburg Cancer Center
Gettysburg, Pennsylvania, United States, 17325
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
United States, Texas
Dallas VA Research Organization
Dallas, Texas, United States, 75216
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Excel Diagnostics & Nuclear Oncology Center
Houston, Texas, United States, 77042
United States, Virginia
UVA Cancer Care
Charlottesville, Virginia, United States, 22903
United States, Washington
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Belgium
Cliniques Universitaires Saint Luc
Brussels, Belgium
Institut Jules Bordet
Brussels, Belgium
University Hospitals Leuven, Campus Gasthuisberg, Department of Nuclear Medicine
Leuven, Belgium, 3000
Canada, British Columbia
BC Cancer - Vancouver
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
London Health Sciences Centre, Division of Nuclear Medicine
London, Ontario, Canada, N6A 5W9
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H8L6
Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
CHUM - Hotel Dieu Hospital
Montréal, Quebec, Canada, H2X OA9
Jewish General Hospital
Montréal, Quebec, Canada, H3T 1E2
Hotel Dieu Hospital in Quebec
Québec, Quebec, Canada, G1R2J6
Denmark
Aalborg University Hospital Klinik Kirurgi-Kræft Clinical Research Unit Department of Oncology
Aalborg, Denmark
Aarhus Universitetshospital
Aarhus, Denmark
Rigshospitalet - University Hospital Copenhagen, Department of Oncology
Copenhagen, Denmark
France
Bergonie Institute
Bordeaux, France, 33076
Center Jean Perrin
Clermont-Ferrand, France
Leon Berard Center
Lyon, France
Centre d'Investigations et de Recherche Clinique en Oncologie Hospital SAINT-LOUIS
Paris, France
Tenon Hospital
Paris, France
Institute Claudius Regaud, Toulouse Cancer Research Center
Toulouse, France
Gustave Roussy Oncology Institute
Villejuif, France
Netherlands
The Netherlands Cancer Institute
Amsterdam, Netherlands, 1066
St. Antonius Hospital
Nieuwegein, Netherlands
Radboud University Medical Center
Nijmegen, Netherlands, 6525 GA
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands
Puerto Rico
VA Caribbean Healthcare System
San Juan, Puerto Rico, 00921
Sweden
Sahlgrenska University Hospital, Department of Oncology
Gothenburg, Sweden
Skane University Hospital
Lund, Sweden
Karolinska University Hospital
Stockholm, Sweden, SE 17176
Norrlands Universitetssjukhus
Umeå, Sweden
Uppsala University Hospital, Department of Oncology
Uppsala, Sweden
United Kingdom
Institute of Cancer Research
Sutton, Surrey, United Kingdom, SM2 5NG
Bristol Hematology & Oncology Center
Bristol, United Kingdom, BS2 8ED
Beatson West of Scotland Cancer Center
Glasgow, United Kingdom, G12 OYN
Royal Surrey County Hospital NHS Foundation Trust
Guildford, United Kingdom
University College London Hospitals NHS Foundation Trust
London, United Kingdom, NW1 2PG
Royal Free London NHS Foundation Trust Royal Free Hospital
London, United Kingdom, NW3 2QG
Guy's Hospital
London, United Kingdom
St Bartholomew's Hospital, West Smithfield
London, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Endocyte
Investigators
Layout table for investigator information
Study Director: Richard Messmann, MD Endocyte

Layout table for additonal information
Responsible Party: Endocyte
ClinicalTrials.gov Identifier: NCT03511664     History of Changes
Other Study ID Numbers: PSMA-617-01
First Posted: April 30, 2018    Key Record Dates
Last Update Posted: August 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Endocyte:
mCRPC
177Lu-PSMA-617
PSMA-617
PSMA-11
radioligand therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases