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HDR Brachytherapy 68-Ga-RM2 PET, 68-Ga-PSMA-11 PET &Multi Parametric MRI in Prostate Cancer

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ClinicalTrials.gov Identifier: NCT04264208
Recruitment Status : Recruiting
First Posted : February 11, 2020
Last Update Posted : February 8, 2021
Sponsor:
Information provided by (Responsible Party):
Andrei Iagaru, Stanford University

Brief Summary:
This study is being conducted to determine whether the combination of imaging agents 68-Ga RM2 and 68-Ga PMSA11 is better at assessing response to high dose rate (HDR) local therapy than standard imaging or biopsy in patients with known prostate cancer (PC)

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: 68-Ga RM2. Drug: 68-Ga PSMA11 Device: PET/MRI Phase 2

Detailed Description:

Primary Objective:

  1. To demonstrate that 68Ga-RM2 and 68Ga-PSMA-11 PET/MRI can detect additional cancers over mpMRI.
  2. To demonstrate that 68Ga-RM2 and 68Ga-PSMA-11 PET/MRI can assess changes in response to treatment and predict progression free survival (PFS) at 24 months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Patients With Low-Risk and Intermediate-Risk Prostate Cancer Scheduled for High-Dose Rate Brachytherapy Using 68-Ga-RM2 PET, 68Ga-PSMA-11 PET and Multi Parametric MRI
Actual Study Start Date : February 5, 2020
Estimated Primary Completion Date : February 2027
Estimated Study Completion Date : February 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: 68Ga-RM2 PET MRI/68Ga PMSA11 PET/MRI
Subjects will undergo either 68Ga RM2 PET/MRI followed within 2 weeks by 68Ga PMSA11 PET/MRI. Two x intravenous (IV) 68Ga-RM2 PET/MRI with a 68Ga dosage of 140 mBq (3.8 mCi), +/- 20%, Two x intravenous (IV) 68Ga-PMSA11 PET/MRI with a 68Ga dosage of 111 to 259 mBq (3 to 7 mCi)
Drug: 68-Ga RM2.
PET radiopharmaceutical
Other Names:
  • BAY86 7548
  • 68Ga DOTA Bombesin

Drug: 68-Ga PSMA11
PET radiopharmaceutical
Other Names:
  • DFKZ 11
  • HBED CC PSMA
  • Heidelberg compound

Device: PET/MRI
PET/MR scanner by GE healthcare
Other Name: PET/MR scanner

Experimental: 68Ga-PSMA-11 PET MRI/68Ga-RM2 PET MRI
Subjects will undergo 68Ga PMSA11 PET/MRI followed within 2 weeks by 68Ga RM2 PET/MRI. Two x intravenous (IV) 68Ga-RM2 PET/MRI with a 68Ga dosage of 140 mBq (3.8 mCi), +/- 20%, Two x intravenous (IV) 68Ga-PMSA11 PET/MRI with a 68Ga dosage of 111 to 259 mBq (3 to 7 mCi)
Drug: 68-Ga RM2.
PET radiopharmaceutical
Other Names:
  • BAY86 7548
  • 68Ga DOTA Bombesin

Drug: 68-Ga PSMA11
PET radiopharmaceutical
Other Names:
  • DFKZ 11
  • HBED CC PSMA
  • Heidelberg compound

Device: PET/MRI
PET/MR scanner by GE healthcare
Other Name: PET/MR scanner




Primary Outcome Measures :
  1. 68-Ga-RM2 and 68-Ga-PSMA-11 PET/MRI can detect additional cancers over mpMRI [ Time Frame: 60 months ]
    Detection of PC lesions will be assessed by 68Ga PSMA 11 and 68Ga RM2 PET scans. The outcome is the number of participants without dispersion, by randomization schedule, for which an assessment of PET based PC lesions is successfully obtained.

  2. 68Ga-RM2 and 68Ga-PSMA-11 PET/MRI can assess changes in response to treatment [ Time Frame: 84 months ]
    Therapeutic response to HDR will be assessed by 68Ga PSMA 11 and 68Ga RM2 PET scans. The outcome is the number of participants without dispersion, by randomization schedule, for which an assessment of PET based therapeutic response to HDR is successfully obtained.

  3. Progression free survival (PFS) [ Time Frame: 24 months ]
    Progression-free survival (PFS) will be assessed as survival without progression at 24 months. The outcome is reported as the number (without dispersion) of the participants alive without progression.



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

Inclusion Criteria:

  • Patients must be at least 18 years of age;
  • Patients must be able to provide informed consent;
  • Histologically proven low-grade or intermediate-grade prostate cancer (PC)
  • Scheduled to undergo targeted local therapy (HDR brachytherapy).

Exclusion Criteria:

  • Inability to lie still for the entire imaging time;
  • Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.);
  • Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance;
  • Metallic implants (contraindicated for MRI).

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): NCT04264208


Contacts
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Contact: Risa Jiron 650-736-1598 rjiron@stanford.edu

Locations
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United States, California
Stanford Cancer Center Recruiting
Stanford, California, United States, 94304
Contact: Risa Jiron    650-736-1598    rjiron@stanford.edu   
Principal Investigator: Andrei H Iagaru, MD         
Sponsors and Collaborators
Andrei Iagaru
Investigators
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Principal Investigator: Andrei H Iagaru, MD Stanford University
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Responsible Party: Andrei Iagaru, Professor of Radiology (Nuclear Medicine), Stanford University
ClinicalTrials.gov Identifier: NCT04264208    
Other Study ID Numbers: IRB-51987
PROS0098 ( Other Identifier: OnCore )
First Posted: February 11, 2020    Key Record Dates
Last Update Posted: February 8, 2021
Last Verified: February 2021
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
Prostatic Diseases
Bombesin
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs