68Ga-PSMA-R2 in Patients With Biochemical Relapse (BR) and Metastatic Prostate Cancer (mPCa)

NCT03490032 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: A206D-A01-001CAAA502A12101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

Brief Summary

This was an open-label, multicenter, single dose, Phase I/II study to evaluate the safety and tolerability of a single administration of 3 mega Becquerel (MBq)/kg, but not less than 150 MBq and not more than 250 MBq, of 68\^Ga-PSMA-R2 in adult male patients with biochemical relapse (BR) and metastatic prostate cancer (mPCa).

Conditions

Prostate Cancer Metastatic

Keywords

Prostatic Neoplasms; Cancer of Prostate; Cancer of the Prostate; Neoplasms, Prostate; Prostate Cancer; Prostatic Cancer; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; PSMA; Prostate-specific membrane antigen; Gallium radioisotope 68; 68Ga-PSMA-R2; 68Ga-PSMA ligand

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events

  Treatment-emergent adverse events (TEAEs) were collected from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent. The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed.

  dosing through 28 days post-dose

Secondary Outcomes (16)

• Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs

  68Ga-PSMA-R2 PET imaging acquired at Day 1 (20-30 min post-injection, 1 hour, 2 hours and 3-4 hours post-injection)

• Phase I: Urinary Excretion of [68Ga]-PSMA-R2

  0 to 6 hours post-dose

• Phase I: Half-life of 68Ga-PSMA-R2 in Blood

  0 to 6 hours post-dose

• Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs

  68Ga-PSMA-R2 PET imaging acquired at Day 1 (20-30 min post-injection, 1 hour, 2 hours and 3-4 hours post-injection)

• Phase I: Residence Times in Normal Organs

  68Ga-PSMA-R2 PET imaging acquired at Day 1

Study Arms (3)

Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)

EXPERIMENTAL

All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].

Drug: [68Ga]-PSMA-R2

Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II)

EXPERIMENTAL

All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].

Drug: [68Ga]-PSMA-R2

Metastatic Prostate Cancer (mPCa) (Phase II)

EXPERIMENTAL

All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].

Drug: [68Ga]-PSMA-R2

Interventions

[68Ga]-PSMA-R2 DRUG

radio-labelled PSMA ligand

Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I); Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II); Metastatic Prostate Cancer (mPCa) (Phase II)

Eligibility Criteria

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

You may qualify if:

• Males 18 years or older.
• Signed and dated written informed consent by the subject prior to any study-specific procedures.
• Histologically confirmed adenocarcinoma of the prostate, defined as follows:
• Biochemical recurrence: defined as PSA is ≥0.2 ng/mL after radical prostatectomy or PSA nadir plus 2 ng/mL after radiation therapy with corresponding CT/MRI or bone scan revealing absence of local recurrence or metastatic lesions.
• Metastatic disease: defined as both, castration-sensitive or castration-resistant mPCa (presence of at least 1 metastatic lymph node, visceral metastasis and/or bone metastasis).
• At least 2 weeks must have elapsed between last anticancer treatment administration and the administration of the imaging product, 68Ga-PSMA-R2.
• Prior major surgery must be at least 12 weeks prior to study entry.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2, with a life expectancy ≥6 months.
• Adequate bone marrow reserve and organ function as demonstrated by complete blood count, and biochemistry in blood and urine at Screening:
• Hemoglobin (Hb): \>8 g/dL
• Platelet count of \>50.000/mm3
• Serum creatinine \<1.5\*upper limit normal (ULN) or estimated glomerular filtration rate (eGFR) \>50 mL/min based upon The Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
• For male subjects with partners of childbearing potential, agreement to use barrier contraceptive method (condom) and to continue its use for 28 days after IP administration.

You may not qualify if:

• Pathological finding consistent with small cell, neuroendocrine carcinoma of the prostate or any other histologies different than adenocarcinoma.
• Administered a radioisotope =\<10 physical half-lives prior to the day of PET/CT.
• Current severe urinary incontinence, hydronephrosis, severe voiding dysfunction, or need of indwelling/condom catheters.
• Uncontrolled pain or incompatibility that results in subject's lack of compliance with imaging procedures.
• Other known coexisting malignancies except non-melanoma skin or low grade superficial bladder cancer unless definitively treated and proven no evidence of recurrence for 5 years.
• Subject with known incompatibility to CT scans.
• Any evidence of severe or uncontrolled systemic or psychiatric diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the subject to participate in the study or which would jeopardize compliance with the protocol, or active infection including human immunodeficiency virus (HIV) and untreated hepatitis B, hepatitis C. Screening for chronic conditions was not required.
• Subjects who have received any investigational agent within the last 28 days were excluded from participation in this study.
• Any acute toxicity due to prior chemotherapy and/or radiotherapy that has not resolved according to the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Studies.
• Known allergy, hypersensitivity, or intolerance to the IP or its excipients.
• Subject unlikely to comply with study procedures, restrictions and requirements and judged by the investigator to be unsuitable for study participation.

Sponsors & Collaborators

• Advanced Accelerator Applications: lead

Study Sites (5)

Pheonix Molecular Imaging Center

Phoenix, Arizona, 85040, United States

Location

University of California, San Francisco (UCSF)

San Francisco, California, 94158, United States

Location

Smilow Cancer Center at Yale New Haven

New Haven, Connecticut, 06510, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

National Institutes of Health, Warren Grant Magnusen Clinical Center

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase I: characterize PK and dosimetry Phase II: diagnostic potential in 2 groups 1. Prostate Cancer in biochemical relapse, and 2. Metastatic Prostate Cancer

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: April 6, 2018
• Study Start: May 23, 2018
• Primary Completion: August 20, 2019
• Study Completion: September 13, 2019
• Last Updated: November 17, 2020
• Results First Posted: November 17, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share

Locations

US (5)