Pimonidazole for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Clinical T4, N1, M1, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, Pimonidazole, for prostate cancer. Researchers aim to determine if Pimonidazole can target the more aggressive and resistant cancer cells, which often cause tumors to return or spread. The trial focuses on men with a specific type of prostate cancer who are planning to undergo prostate removal surgery. Those with intermediate or high-risk prostate cancer scheduled for surgery might be suitable candidates for this study. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research that could lead to new treatment options for prostate cancer.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Pimonidazole is safe for prostate cancer treatment?

Research has shown that pimonidazole is primarily used to study low oxygen levels in tumors. It is currently being tested in prostate cancer and other cancer types. Doctors typically administer pimonidazole intravenously before a biopsy to help identify low-oxygen areas in cancer cells.

The safety of pimonidazole in humans appears promising, as it is already used to enhance understanding of cancer. However, limited information is available about side effects or patient experiences. Despite this, its use in medical research provides doctors with some familiarity.

If pimonidazole were in the early stages of testing, less safety information would be available. However, its use in clinical research offers some confidence in its safety when used carefully. Prospective trial participants should consult a doctor about possible side effects to understand what to expect. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for prostate cancer, which often involve hormone therapy, surgery, or radiation, Pimonidazole offers a unique approach by targeting hypoxic cells. Researchers are excited about Pimonidazole because it acts as a hypoxia marker, specifically binding to low-oxygen areas in tumors. This feature could allow for better identification of aggressive cancer regions, potentially leading to more precise and effective treatment strategies. By focusing on these hard-to-treat hypoxic areas, Pimonidazole may enhance the accuracy and effectiveness of existing treatment plans.

What evidence suggests that Pimonidazole might be an effective treatment for prostate cancer?

Research has shown that pimonidazole is a useful tool for identifying low-oxygen (hypoxic) areas in prostate tumors. Studies have found that these hypoxic areas are often more aggressive and harder to treat. Specifically, pimonidazole attaches to low-oxygen cells in prostate cancer in about 92% of cases, demonstrating its effectiveness in identifying them. This is crucial because these cells are tougher to treat and more likely to recur. By targeting these cells, pimonidazole could aid in developing better treatment plans for aggressive prostate cancer. Evidence suggests that pimonidazole might be effective in identifying and possibly treating challenging prostate cancer cases. Participants in this trial will receive pimonidazole to evaluate its effectiveness in identifying hypoxic areas in prostate tumors. ^{2 6 7 8 9}

Who Is on the Research Team?

Alejandro Berlin, MD.

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

This trial is for men with intermediate to high-risk prostate cancer who are set to have surgery at Princess Margaret Cancer Centre-UHN. They should have a Gleason score of 7 with more than half of biopsies showing tumor, or score 8+. The cancer must be adenocarcinoma and not spread beyond the prostate (T2-T3 N0 M0). Men can't join if they can't take pimonidazole tablets or if their cancer has spread further (T4, N1, M1) or isn't adenocarcinoma.

Inclusion Criteria

My prostate cancer is classified as adenocarcinoma.

I have prostate cancer and will have surgery at Princess Margaret Cancer Centre-UHN.

My cancer is in stage T2-T3, has not spread to lymph nodes or other parts of the body.

Exclusion Criteria

My cancer is not adenocarcinoma.

You are not able to swallow pimonidazole tablets.

My cancer has spread to nearby or distant parts of my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo radical prostatectomy to obtain specimens for analysis

1 day

1 visit (in-person)

Laboratory Analysis

Specimens are analyzed for pimonidazole staining and tumor initiating cells

3 years

Follow-up

Participants are monitored for biochemical failure and other outcomes

3 years

What Are the Treatments Tested in This Trial?

Interventions

• Pimonidazole

Trial Overview The study is testing Pimonidazole in patients undergoing surgery for prostate cancer. It aims to isolate aggressive cancer cells from removed prostates to see how they behave and respond to treatments when grown in mice. This could help develop therapies targeting resistant prostate cancer cells.

How Is the Trial Designed?

Group I: Pimonidazole Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11186205/

Oral pimonidazole unveils clinicopathologic and epigenetic ... Oral pimonidazole unveils clinicopathologic and epigenetic features of hypoxic tumour aggressiveness in localized prostate cancer.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4763504/

Oxygen supply maps for hypoxic microenvironment ... To verify that pimonidazole serves as a robust marker for hypoxia in prostate cancer cells, we incubated LNCaP cells (American Type Culture ...

3. ar.iiarjournals.org ar.iiarjournals.org/content/43/1/351

Exploring Hypoxia in Prostate Cancer With T2-weighted ... The aim of this study was to determine whether hypoxia in prostate tumors could be identified using a radiomics model extracted from T2-weighted MR images.

4. redjournal.org redjournal.org/article/S0360-3016(05)03078-6/abstract

An immunohistochemical assessment of hypoxia in ... Results: Thirty-seven patients completed the study. Pimonidazole binding was present in prostate carcinomas in 34 of 37 patients (92%) and in benign prostatic ...

5. link.springer.com link.springer.com/article/10.1007/s11547-023-01644-3

Prediction of prostate tumour hypoxia using pre-treatment ... The results showed that the integration of RFs from MRI helped improve the prediction of hypoxia in patients with prostate cancer, with the ...

6. nature.com nature.com/articles/bjc2014604

The tumour hypoxia marker pimonidazole reflects ... - Nature Pimonidazole staining reflects an aggressive hypoxic phenotype of prostate cancer characterised by upregulation of proliferation, DNA repair and hypoxia ...

7. pubchem.ncbi.nlm.nih.gov pubchem.ncbi.nlm.nih.gov/compound/Pimonidazole

Pimonidazole | C11H18N4O3 | CID 50981 - PubChem - NIH Pimonidazole is a C-nitro compound. ChEBI. Pimonidazole is under investigation for the diagnostic of Prostate Cancer and Head and Neck Cancer. DrugBank.

8. medchemexpress.com medchemexpress.com/pimonidazole-hydrochloride.html?srsltid=AfmBOooaYsJID-Egb4BpL-hA0fZzL4cRvYzXWKG-PRxDU1Qp9yt0xwJq

Pimonidazole hydrochloride | Hypoxia Marker Pimonidazole is a novel hypoxia marker for complementary study of tumor hypoxia and cell proliferation in tumor. Pimonidazole accumulates in hypoxic cells ...

9. sciencedirect.com sciencedirect.com/topics/medicine-and-dentistry/pimonidazole

Pimonidazole - an overview Pimonidazole is a hypoxia-specific marker. It is administered intravenously prior to biopsy and undergoes reduction in hypoxic cells to form adducts.