Ga-68 PSMA-HBED-CC PET for Relapse

Phase-Based Estimates
1
Effectiveness
2
Safety
The University of Iowa Hospitals & Clinics, Iowa City, IA
Relapse+3 More
Ga-68 PSMA-HBED-CC PET - Drug
Eligibility
18+
Male
Eligible conditions
Relapse

Study Summary

This study is evaluating whether a new drug (PSMA) makes prostate cancer easier to identify in positron-emission tomography (PET) imaging. If this works, prostate cancer treatments can be prescribed that match the location of the disease. PS

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Eligible Conditions

  • Relapse
  • Recurrence
  • Cancer
  • Prostate Cancer
  • Prostatic Cancer, Castration-Resistant
  • Neoplasms
  • Prostatic Neoplasms
  • Prostatic Neoplasms, Castration-Resistant

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Ga-68 PSMA-HBED-CC PET will improve 2 primary outcomes and 4 secondary outcomes in patients with Relapse. Measurement will happen over the course of through 24 hours post-injection of 68Ga PSMA.

Month 12
Determine detection rates on a per-subject basis of 68Ga PSMA-HBED-CC PET/CT when stratified by PSA value
Determine positive predictive value on a per-subject and per-region basis of 68Ga PSMA PET scans for detection of tumor location
Determine sensitivity on per-subject and per-region basis of 68Ga PSMA-HBED-CC PET/CT for detecting tumor location, confirming with histopathology.
Month 12
Determine sensitivity on a per-patient basis of 68Ga PSMA PET scans for detection of tumor location [CT.gov: ref: NCT03389451 for all comments]
Determine sensitivity on a per-region basis of 68Ga PSMA PET scans for detection of tumor location
Hour 24
Evaluate adverse events of 68Ga PSMA PET scan

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Control
68Ga PSMA PET scan

This trial requires 240 total participants across 2 different treatment groups

This trial involves 2 different treatments. Ga-68 PSMA-HBED-CC PET 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 2 & 3 and have had some early promising results.

68Ga PSMA PET scan
Drug
Ga-68 PSMA-HBED-CC PET/CT scan
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 and 12 months after 68ga psma pet scan
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3 and 12 months after 68ga psma pet scan for reporting.

Closest Location

The University of Iowa Hospitals & Clinics - Iowa City, IA

Eligibility Criteria

This trial is for male patients aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
No other malignancy within the past 2 years (skin basal cell or cutaneous superficial squamous cell carcinoma or superficial bladder cancer are exempt from this criterion).
Karnofsky performance status greater than or equal to 50 (ECOG/WHO 0, 1, or 2) within the last 3 months.
Ability to understand and willingness to provide informed consent.
Pathologically proven prostate adenocarcinoma.
Rising PSA after definitive therapy with a prostatectomy or radiation therapy (external beam radiation therapy or brachytherapy).
If post-radical prostatectomy, a PSA level of > 0.2 ng/mL measured more than 6 weeks post-operatively with a second confirmatory persistent PSA > 0.2 ng/mL.
If post-radiation therapy, a PSA level that is equal to, or greater than, a 2 mg/mL rise above the lowest PSA value ('nadir').
A PSA level result within the last 2 months meeting criteria above.
Not receiving any other investigational agents (i.e., unlabeled drugs or drugs under an IND for initial efficacy investigations).

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of relapse?

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There are several signs of relapse including worsening neurologic symptoms, worsening of fatigue, changes in sleep patterns and mood. Other signs of relapse include, unexplained weight loss, cough, and shortness of breath.

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What is relapse?

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The most significant risk factor of relapse among the BCT participants was inadequate monitoring of the relapse status, which was mainly attributed to the omission of the first review visit. Relapse risk depended on the relapse status with high rate of relapse among the participants who were detected at an earlier relapse stage. The first evaluation visits, however, were performed without sufficient follow-up information, contributing to a delayed treatment, which was in conjunction with a more complicated relapse profile among the participants.

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What causes relapse?

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The data obtained in this retrospective study indicate that a new attack of acute disease or relapse should not be viewed as an end in itself (even if it would only consist in the loss of the function of a single joint or a handful of joints), unless all the patients are in a severe state of illness, as they often have to be. Treatments and follow up on a regular basis is therefore vital: for these patients remission and prevention is the only strategy for the future. However, further prospective studies are required to evaluate whether long-term follow up is mandatory even for those patients who have been in remission for a reasonable amount of time.

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Can relapse be cured?

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It is difficult to determine the relapse-free or cure rates of an ICR because of the many factors that can modulate relapses. It may be useful to consider the cumulative relapse rate of the drug over time in the view of achieving the clinical remission goal. With careful long-term use of the drugs, most patients remain in remission for a relatively long-term time.

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How many people get relapse a year in the United States?

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This analysis of the data from 937,000 Americans' hospitalizations from 2013 to 2015 revealed substantial disparities between states in rates of relapse, with Mississippi having the highest rate and New Mexico having the lowest rate. The state with the highest risk of relapse was also a state where Medicaid was the majority of the coverage for healthcare. Thus, to optimize outcomes when designing programs and interventions for the management of relapse, we recommend analyzing data from hospitals in states where Medicaid is the majority of coverage, so that we can account for the possible negative effects of Medicaid; we also recommend analyzing data from states where Medicaid is largely supplanted by private insurance or Medicare but with a substantial number of Medicaid enrollees.

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What are common treatments for relapse?

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If relapse occurs, a full course of treatment must be initiated within a few months to prevent further relapse. Treatments for relapse included the addition of antidepressant medication, in conjunction with therapy of the anxiety and depression that preceded relapse.

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Does ga-68 psma-hbed-cc pet improve quality of life for those with relapse?

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Patients treated with PET prior to reintervention with Tc can experience statistically significant improvements in QOL. Results from a recent clinical trial support early use of PET for treatment in patients with a history of relapse.

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What is the survival rate for relapse?

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We found no difference in relapse rate between those requiring a single and those requiring a second intervention. The patients requiring a second intervention did have a lower survival rate after relapse. It is important to ensure that patients are informed about this possibility and informed consent is obtained prior to further intervention. The patient should be informed of the potential advantages of each treatment.

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What are the latest developments in ga-68 psma-hbed-cc pet for therapeutic use?

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Our experience indicates that for selected patients, Tc-201 can obtain good results by using higher doses in a reasonable span of time. In many cases, it may be advisable to prescribe treatments in larger amounts of drug for longer periods of time than used previously.

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Is ga-68 psma-hbed-cc pet safe for people?

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Injection of the (Ga)68 Hbed(cc) pet with a dose of 0.8-2M absorbed activity is well tolerated. The injection can be performed safely by healthcare professionals or even children, particularly in cases in which the patient has previously been treated with the radionuclide (Ga)68 Hbd-cc PET, and in cases at high risk for acute radiation syndrome.

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What is ga-68 psma-hbed-cc pet?

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Ga-68 has become the radiotracer of choice for PET imaging of lymphoid tissues. This review examines the clinical relevance and potential of gallium-68 positron emission tomography for the detection of active lesions in patients with acute and relapsing lymphoma. The high sensitivity that our data show suggests that PET imaging with Gallium-68 is a reliable and highly sensitive imaging technique for detecting active, untreated lymphoma lesions.

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What is the primary cause of relapse?

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Primary cause of relapse is unknown and it needs to be identified in order to develop appropriate treatments in this group of patients. The relapse is the end results of two main mechanisms. First of all, the inflammatory mechanisms may contribute to the relapse in two ways. First of all, they may not only provoke the symptomatology but also intensify and aggravate it. Moreover, the inflammatory mechanisms may play some role in the maintenance of weight gain as well in the relapses. Lastly, the inflammatory mechanisms may play a role in the development of the neurological and endocrine symptoms.Second of all, they may contribute to weight maintenance. The treatment must consider these mechanisms to reach a complete remission in obese patients.

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