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Lutetium-177 (Lu177) Prostate-Specific Antigen (PSMA)-Directed EndoRadiotherapy (RESIST-PC)

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: NCT03042312
Recruitment Status : Active, not recruiting
First Posted : February 3, 2017
Last Update Posted : February 7, 2019
Sponsor:
Information provided by (Responsible Party):
Endocyte

Brief Summary:
Studies will assess safety and efficacy of 177Lu-PSMA-617 in patients with metastatic castration resistant prostate cancer.

Condition or disease Intervention/treatment Phase
Metastatic Castration Resistant Prostate Cancer Drug: Lu177-PSMA-617 Phase 2

Detailed Description:

Primary goal of this study is evaluation of safety and efficacy of 177Lu-PSMA-617.

Safety of 177Lu-PSMA-617 (Radioligand Therapy) RLT will be assessed by analysis of toxicity. Descriptive statistics (number and percentage) will be reported separately for Adverse Events (AE) in total and Serious Adverse Events (SAE). These descriptive statistics will be presented for the whole treatment as well as separate for each cycle. In addition, the relationship of AE to the study drug (related, not related) will be reported. Both results from laboratory test, physical examinations and patients surveys will be included.

Efficacy of 177Lu-PSMA-617 will be reported using descriptive statistics by means of number and percentage of patients with ≥50% decline at 12-weeks from baseline.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PSMA-directed endoRadiothErapy of Castration-reSISTant Prostate Cancer (RESIST-PC). A Phase II Clinical Trial
Actual Study Start Date : July 12, 2017
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : April 11, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Lu177-PSMA-617-dose 1
Repeated i.v. application of 6.0 GBq (gigabequerel )(±10%, arm 1) every 8±1 weeks;RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry
Drug: Lu177-PSMA-617
Lutetium (177Lu) -DOTA (1,4,7,10-tetra-azacyclododecane-N,N',N'',N'''-tetraacetic acid )-PSMA has three components: PSMA is the targeting vector , DOTA (1, 4, 7, 10-tetraazacyclododecane-1, 4, 7, 10-tetraacetic acid) is a radiometal chelator and a linking group, and 177Lu is the beta emitter that upon internalization delivers radiation to the nucleus of tumor cells to cause DNA damage. The targeting vector utilizes glu-urea-lys sequence which is an inhibitor capable of binding to the domain of PSMA. These components have been previously used in human subjects and in medical research.
Other Name: Lu177 RLT

Experimental: Lu177-PSMA-617- dose 2
Repeated i.v. application of 7.4 GBq (±10%, arm 2) of drug every 8±1 weeks;RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry
Drug: Lu177-PSMA-617
Lutetium (177Lu) -DOTA (1,4,7,10-tetra-azacyclododecane-N,N',N'',N'''-tetraacetic acid )-PSMA has three components: PSMA is the targeting vector , DOTA (1, 4, 7, 10-tetraazacyclododecane-1, 4, 7, 10-tetraacetic acid) is a radiometal chelator and a linking group, and 177Lu is the beta emitter that upon internalization delivers radiation to the nucleus of tumor cells to cause DNA damage. The targeting vector utilizes glu-urea-lys sequence which is an inhibitor capable of binding to the domain of PSMA. These components have been previously used in human subjects and in medical research.
Other Name: Lu177 RLT




Primary Outcome Measures :
  1. Determination of number of patients responding to therapy measured by comparison of baseline to follow-up decline in tumor marker level (PSA) ≥50% at 12 weeks. [ Time Frame: 48 months ]
    A number of responders will be determined in both treatment groups (6.0 vs. 7.4 GBq 177Lu-PSMA-617) and a statistically significant difference will be evaluated..


Secondary Outcome Measures :
  1. Determination of the progression-free survival (PFS) measured from the start of therapy until death or PSA progression. [ Time Frame: 48 months ]

    For patients with PSA decline after start of treatment, PSA progression is defined as time from baseline to time the PSA increases to 25% and 2 ng/ml above nadir which is confirmed by a second value ≥3 weeks later For patients without PSA decline, PSA progression is defined, as the time from baseline to time, the PSA increases to 25% and 2 ng/ml above baseline which is confirmed by a second value ≥3 weeks later.

    PFS will be determined separately for both treatment groups (6.0 vs. 7.4 GBq 177Lu-PSMA-617) and a statistically significant difference will be evaluated.


  2. Determination of maximum PSA decline [ Time Frame: 48 months ]
    For patients with PSA decline after start of treatment , PSA progression is defined as time from baseline to time the PSA increases to 25% and 2 ng/ml above nadir which is confirmed by a second value ≥3 weeks later



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Prostate cancer proven by histopathology
  2. Unresectable metastases
  3. Progressive disease, both docetaxel naive and docetaxel treated.
  4. Castration resistant disease with confirmed testosterone level ≤50 ng/ml under prior androgen deprivation therapy (ADT)
  5. Positive 68Ga-PSMA-11 PET/CT (positron emission computed tomography ) or diagnostic 177Lu-PSMA-617 scintigraphy
  6. ECOG 0-2
  7. Sufficient bone marrow capacity as defined by WBC (white blood cell ) ≥2.500/μl, PLT (platelet) count ≥100.000/μl, Hb≥9.9 g/dl and ANC≥1500 mm3 for the first cycle and WBC≥2.000/ μl,PLT count ≥75.000/μl, Hb≥8.9 g/dl and ANC≥1000 mm3 for the subsequent cycles
  8. Signing of the Informed Consent Form
  9. Patients enrolling in this trail should have received either Enzalutamide or Abiraterone

Exclusion Criteria:

  1. Less than 6 weeks since last myelosuppressive therapy (including Docetaxel, Cabazitaxel, 223Ra, 153Sm) or other radionuclide therapy.
  2. Glomerular Filtration Rate (GFR) <40 ml/min
  3. Serum creatinine > 1.5 ULN
  4. AST and ALT>5xULN
  5. Urinary tract obstruction or marked hydronephrosis
  6. Diffuse bone marrow involvement confirmed by super-scans

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): NCT03042312


Locations
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United States, California
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095
United States, Texas
Excel Diagnostics and Nuclear Oncology Center
Houston, Texas, United States, 77042
Sponsors and Collaborators
Endocyte
Investigators
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Study Director: Richard Messmann, MD Endocyte

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Responsible Party: Endocyte
ClinicalTrials.gov Identifier: NCT03042312     History of Changes
Other Study ID Numbers: PSMA-617-02
133661 ( Other Identifier: Original sponsor )
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: February 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

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases