68Ga-HBED-CC-PSMA PET/CT for Prostate Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Jewish General Hospital, Montreal, Canada
Prostate Cancer+1 More
68Ga-HBED-CC-PSMA PET/CT - Drug
Eligibility
18+
Male
Eligible conditions
Select

Study Summary

This study is evaluating whether a PET scan can be used to diagnose prostate cancer and to help decide which patients should be treated.

See full description

Eligible Conditions

  • Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

This trial is evaluating whether 68Ga-HBED-CC-PSMA PET/CT will improve 3 primary outcomes in patients with Prostate Cancer. Measurement will happen over the course of 7 days.

12 months
Efficacy of Ga68-PSMA PET/CT imaging as measured by sensitivity and specificity vs CT on a per lesion basis as compared to standard of truth
Efficacy of Ga68-PSMA PET/CT imaging as measured by sensitivity and specificity vs CT on a per patient basis as compared to standard of truth
7 days
Safety of Ga68-PSMA PET/CT imaging as measured by the incidence of adverse events (AE)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

1 Treatment Group

68Ga-PSMA PET/CT
1 of 1
Experimental Treatment

This trial requires 1500 total participants across 1 different treatment group

This trial involves a single treatment. 68Ga-HBED-CC-PSMA PET/CT is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

68Ga-PSMA PET/CT
Drug
68Ga-HBED-CC-PSMA PET/CT

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 months for reporting.

Who is running the study

Principal Investigator
S. P.
Stephan Probst, MD
Sir Mortimer B. Davis - Jewish General Hospital

Closest Location

Jewish General Hospital - Montreal, Canada

Eligibility Criteria

This trial is for male patients aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Resident of Canada
Male sex
Age 18 years or older
Previously diagnosed with prostate cancer, under referring physician's care
ECOG performance status 0 - 3, inclusive
Able to understand and provide written informed consent
Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine (or prone) for up to 40 minutes and tolerating intravenous cannulation
Global

Patient Q&A Section

What are common treatments for prostate cancer?

"While radiation therapy and adjuvant hormonal treatment are often used in the initial management of prostate cancer, newer medications (such as abiraterone and enzalutamide) demonstrate improved efficacy compared to standard care (through androgen deprivation or bisphosphonate) in certain cohorts. When offered to older men, the benefit of abiraterone is greatest among men with metastatic disease. Abiraterone may be considered in men with low-risk localized prostate cancer and favorable pathology. Combination treatments of hormonal and abiraterone (CHAMPS) may allow for selection of optimal treatment in men who cannot receive either agent alone." - Anonymous Online Contributor

Unverified Answer

Can prostate cancer be cured?

"The question of cure can be answered with high certainty only for a small subset of patients. There are many other aspects of management of prostate cancer." - Anonymous Online Contributor

Unverified Answer

How many people get prostate cancer a year in the United States?

"Most prostate cancer will be diagnosed in men younger than 60 years old and those over 70 years older. Age and sex are risk factors for prostate cancer. Many men with prostate cancer are diagnosed after their screening PSA is performed, which demonstrates how important it is for men to be screened for prostate cancer as soon as they are diagnosed with some prostate cancer." - Anonymous Online Contributor

Unverified Answer

What are the signs of prostate cancer?

"In particular, patients with [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) are at higher risk for depression, fatigue and anorexia compared to men that have not developed cancer. Men are at risk for developing prostate cancer as a means of mitigating their sense of isolation. These early life factors should prompt earlier diagnosis and increased screening of cancer in men because the signs of prostate cancer can be missed." - Anonymous Online Contributor

Unverified Answer

What causes prostate cancer?

"Prostate cancer is a disease of unknown cause, but multiple pathways trigger the transformation of normal cells into cancerous ones. There is no conclusive proof of a single, specific cause for prostate cancer, as the disease is genetically and environmentally influenced." - Anonymous Online Contributor

Unverified Answer

What is prostate cancer?

"Recent findings indicated that [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) is a cancer of the exocrine glands. Symptoms of high urgency, dysuria, excessive frequency of bowel movements, and pain with intercourse are the main presenting symptoms of prostate cancer. However, symptoms such as the urgency, dysuria, and frequency may be underestimated. Diagnosis and treatment of prostate cancer have been improved. Awareness among men and their physicians may lead to early diagnosis of prostate cancer and to improved treatment outcome." - Anonymous Online Contributor

Unverified Answer

What does 68ga-hbed-cc-psma pet/ct usually treat?

"PET demonstrated no significant change to plan between 68Ga-PET and 99mTc-PSA. PET did show significant changes between 68Ga-PET and 68Ga-Tc-PSA. 68Ga-PET can be used as a supplementary diagnostic tool as a method to assess the degree of tumour burden. The imaging findings confirmed metastatic behaviour of 68Ga-PET or 68Ga-Tc-PSA. PET did not predict the size of the primary tumour. However, PET scans may play a significant role in detecting micrometastatic disease (which would not be detected by biochemical markers)." - Anonymous Online Contributor

Unverified Answer

What is the latest research for prostate cancer?

"This article provides an overview of the recent research on prostate cancer, including articles that report the advancement of prostate cancer prevention or chemotherapies that may have therapeutic effects in treating prostate cancer. Furthermore, the article also serves as a reminder of the limitations of the clinical trials that are the basis for the advancement of knowledge of prostate cancer and the improvement of treatment of prostate cancers." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving 68ga-hbed-cc-psma pet/ct?

"With our findings, we may have found a candidate to add in the therapeutic toolbox for LUTS. We have therefore undertaken a large multicenter trial with the focus on further defining the therapeutic efficacy of 68Ga-HBED-cc-PSMA pet PET/CT in patients with a clinical suspicion of LUTS caused by bladder neck dysfunction, and potentially also of (bladder neck) prostatitis." - Anonymous Online Contributor

Unverified Answer

Is 68ga-hbed-cc-psma pet/ct typically used in combination with any other treatments?

"It could not be determined the effectiveness of 68Ga-HEDEC-CCPSA with concurrent chemotherapy or CT alone, to define the clinical effectiveness of PETCT. Findings from a recent study of this retrospective study, therefore, are not indicative. It could not be defined the effectiveness of 68Ga-HEDEC-CCPSA in combination with other treatments. Findings from a recent study of this retrospective study, therefore, are not indicative. In terms of the prognosis of the patients, the results of this study are not indicative." - Anonymous Online Contributor

Unverified Answer

How quickly does prostate cancer spread?

"The metastasis-free survival rate of prostate cancer patients is influenced by many variables, such as tumour size, metastatic involvement, grade of differentiation, PSA concentration and treatment. Survival was highest for patients with the lowest PSA-levels." - Anonymous Online Contributor

Unverified Answer

Has 68ga-hbed-cc-psma pet/ct proven to be more effective than a placebo?

"Recent findings of meta-analysis of the current data are limited by their small numbers due to the availability of only one comparative investigation. However, our data suggest that 68Ga is effective regarding patient survival when used in conjunction with a low dose of the chelate generator CC-PSMA." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Prostate Cancer by sharing your contact details with the study coordinator.