NCT04614363

68 Ga-PSMA for High Risk Prostate Cancer

Completed Phase 1, PHASE2 Results posted Last updated 28 August 2023

What this trial tests

Phase 1, PHASE2 trial testing 68Ga-PSMA in Prostate Cancer in 80 participants. Completed in 25 April 2023.

Timeline

13 October 2020

Primary endpoint
26 February 2022

25 April 2023

Quick facts

Lead sponsor	The Methodist Hospital Research Institute
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	80
Start date	13 October 2020
Primary completion	26 February 2022
Estimated completion	25 April 2023
Sites	1 location across United States

Drugs / interventions tested

• 68Ga-PSMA — full drug profile →

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →
• High Risk — all drugs for High Risk →

Sponsor

The Methodist Hospital Research Institute

Who can join

21 and older, male only, with Prostate Cancer or High Risk. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Proportion of Patients With Lymph Node Involvement Primary · 18 months

Number of patients with cTxNoMo (clinically localized disease) found on final histological examination to have lymph node involvement as determined by 68GA-PSMA-11 PET/CT.

Group	Value	95% CI
Localized High Risk Prostate Cancer	4
Biochemical Recurrence	28

Proportion of Patients Which Clinical Management Was Altered Primary · 18 months

Number of patients in which 68GA-PSMA-11 PET/CT altered the planned clinical management.

Group	Value	95% CI
Localized High Risk Prostate Cancer	2
Biochemical Recurrence	30

Intensity of Uptake as a Predictor of Clinical Outcome or Aggressiveness Secondary · 18 months

Uptake intensity detected on PET/CT in the prostate and outside of the prostate

SUV (mean) inside the prostate : mean SUV

Group	Value	95% CI
Localized High Risk Prostate Cancer	22.45	3.9 – 105.7
Biochemical Recurrence	0	0 – 0

SUV (mean) outside the prostate

Group	Value	95% CI
Localized High Risk Prostate Cancer	43.8	12.8 – 74.9
Biochemical Recurrence	16.9	2.1 – 99.7

Number of Patients With Suspicious Lesions Secondary · 18 months

Number of patients in which 68Ga-PSMA 11 PET/CT showed suspicious lesions that are were not seen in standard diagnostic modalities of bone scan, CTs or MRI.

Group	Value	95% CI
Localized High Risk Prostate Cancer	4
Biochemical Recurrence	17

Adverse events — posted to ClinicalTrials.gov

Time frame: Participants were followed at 2 and 6 months post PET scan.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Localized High Risk Prostate Cancer

Serious: 1/30 (3%)

Deaths: 0/30

Biochemical Recurrence

Serious: 2/50 (4%)

Deaths: 2/50

Serious adverse events (3 terms)

Reaction	System	Localized High Risk Prosta…	Biochemical Recurrence
Encephalopathy	Nervous system disorders	—	—
Prostate cancer metastasis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Acute cerebrovascular accident	Nervous system disorders	—	—

Most-reported serious reactions: Encephalopathy, Prostate cancer metastasis, Acute cerebrovascular accident.

Data from ClinicalTrials.gov NCT04614363 adverse events section.

Sponsor's own description

This is a prospective, single-center, open-label pilot study of 68GA-PSMA-11 given at a single time prior to PET/CT imaging in men with localized high risk prostate cancer or biochemical recurrence. The imaging agent (68 Ga-PSMA 11 will be administered on an outpatient basis. It will be administered prior to the PET/CT imaging. The objective is to evaluate the distribution of 68GA-PSMA-11 in tissues and to determine if this alters the planned clinical management.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Novel Tracers and Radionuclides in PET Imaging.
   Mason C, Gimblet GR, Lapi SE, Lewis JS. · · 2021 · cited 10× · PMID 34392925 · DOI 10.1016/j.rcl.2021.05.012
2. Management of Patients with Recurrent and Metachronous Oligometastatic Prostate Cancer in the Era of PSMA PET.
   Sabbagh A, Mohamad O, Lichter KE, Hope TA. · · 2022 · cited 9× · PMID 36551678 · DOI 10.3390/cancers14246194