Castration Resistant Prostate CancerPhase 2EVONCT06836726
Clinical Trial to Test Efficacy of Targeting Hypoxia Combined With ARSI After First-line ARSI Therapy for Castrate Resistant Prostate Cancer
A Phase 2 study testing Evofosfamide in people with Castration Resistant Prostate Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This is a single-institution, single-arm, open-label Phase 2 trial evaluating evofosfamide in subjects with M1 CRPC who fail first-line ARSIs. In those progressing after second-line Docetaxel or deemed ineligible to it, the use of alternate ARSI remains the most common line of therapy in our Province, in keeping with… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Castration Resistant Prostate Cancer
- What is being tested?
- Evofosfamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2026to 1 Oct 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age;
- Ability to understand the purposes and risks of the trial and has signed a written ICF approved by the investigator's REB;
- CRPC stage M1 based on conventional imaging (CT and/or bone scan) or PSMA PET;
- Progression (i.e., PSA rise of 25% or more, and absolute increase of 2 ng/mL or more from the nadir) to first-line ARSIs (Abi or Enza or Daro or Apa monotherapy) and subsequent docetaxel or deemed ineligible for it;
- Ongoing castration therapy (e.g., surgical or medical with LHRH agonists/antagonist), with baseline testosterone level <50ng/dL;
- Eastern Cooperative Oncology Group (ECOG) Performance status 0-2;
- In subjects with known significant pulmonary disease (severe chronic obstructive or other pulmonary disease with hypoxemia), measure oxygen saturation using pulse oximeter after a 2-minute walk. Subjects must have oxygen saturation ≥90% to be eligible for the trial.
Who cannot join
- 1. ANC <1,000/mm3, and/or hemoglobin <9.0 g/dL, and/or platelet count <100,000/mm3; independent of transfusion and/or growth factors 2. Liver dysfunction: total bilirubin, serum glutamic oxaloacetic transaminase (SGOT; aspartate aminotransferase [AST]) and/or serum glutamic-pyruvic transaminase (SGPT; alanine aminotransferase [ALT]) >1.5 × upper normal limit (UNL); 3. Inadequate renal function: creatinine >1.5 × UNL, or eGFR <40 mL/min; 4. Any Grade 3 or greater toxicity experienced during treatment with prior ARSI; 5. Severe, active co-morbidity defined as follows:
- Myocardial infarction within 6 months prior to date of enrollment.
- Current severe or unstable angina.
- New York Heart Association Functional Classification III/IV. (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.)
- Severe chronic obstructive or other pulmonary disease with hypoxemia at rest (requires supplementary oxygen, symptoms due to hypoxemia).
- History of any condition that in the opinion of the investigator, would preclude participation in this study.
Show all 20Show fewer
- 6. Known liver metastases based on conventional imaging (i.e., abdominal CT and/or MR).
- 7. Known brain, leptomeningeal or epidural metastases (unless treated, well controlled, and not requiring steroidal therapy for at least 3 months).
- 8. Major surgery (other than diagnostic surgery), open biopsy, or significant traumatic injury, ≤28 days prior to the date of signing informed consent. Subject must have completely recovered from surgery.
- 9. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
- 10. Treatment of PCa with radiation therapy or surgery ≤28 days prior to the Cycle 1 Day 1.
- 11. Prior therapy with a hypoxic cytotoxin. 12. HIV-infected patients with detectable viral load and/or on effective anti-retroviral therapy (ART) with undetectable viral load for less than 6 months. Note: HIV testing is not required for eligibility for this protocol. Drug-drug interactions with ART occur via many mechanisms, with cytochrome P450 CYP3A4-mediated interactions being the most common. Patients who are using concurrent strong or moderate CYP3A4 inhibitors (e.g., ritonavir, cobicistat) or strong or moderate CYP3A4 inducers must be switched to an alternate effective ART regimen ≥4 weeks before study enrollment or should be excluded from the study if their regimen cannot be altered.
- 13. Active infection with hepatitis B or hepatitis C (i.e., detectable viral load) with or without active treatment in patients with previously known infection. Note: Only Hepatitis B testing is required for eligibility for this protocol as per standard practice prior to systemic therapy.
- 14. Subjects who have exhibited allergic reactions to a structural compound similar to evofosfamide or the drug product excipients.
- 15. Subjects who are taking medications that prolong QT interval and have a risk of Torsades de Pointes (see Appendix A).
- 16. Subjects with a QTc interval calculated according to Fridericia formula (QTC = QT / RR1/3) of >450 msec based on screening electrocardiogram (ECG).
- 17. Subjects with a history of long QT syndrome. 18. Subjects taking a medication that is a moderate or strong inhibitor or inducer of CYP3A4within 14 days or 5 half-lives (whichever is longer) prior to signing of ICF. (see Appendix B).
- 19. Subjects taking a medication that is a sensitive substrate or substrates with a narrow therapeutic index of CYP3A4, CYP2D6, or CYP2C9 (see Appendix C).
- 20. Any other significant concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this trial.
- 21. Unwillingness or inability to comply with the study protocol for any reason.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Princess Margaret Cancer Center
Toronto, Ontario, M7A 2S4
Alejandro Berlin, MD, 416-946-4501 ext. 5813, Alejandro.Berlin@uhn.ca
About this study
Official title: Phase II Clinical Trial to Test Efficacy of Targeting Hypoxia Combined With ARSI After First-line ARSI Therapy for Castrate Resistant Prostate Cancer
This is a single-institution, single-arm, open-label Phase 2 trial evaluating evofosfamide in subjects with M1 CRPC who fail first-line ARSIs. In those progressing after second-line Docetaxel or deemed ineligible to it, the use of alternate ARSI remains the most common line of therapy in our Province, in keeping with recent international recommendations. After baseline molecular imaging (PSMA and fluorodeoxyglucose (FDG) PET/CT), prior to evofosfamide initiation, subjects will be encouraged to undergo biopsy of a dominant lesion: FDG-, PSMA-uptake and/or conventional imaging determined (in order, and according to feasibility). Subjects will then receive the alternate ARSI (i.e., different from the one received in first line) as per current standard practice and Provincial drug plan coverage. Additionally, subjects will receive combinatorial evofosfamide at a dose of 480 mg/m2 intravenously (IV) over 60 minutes on Days 1, 8 and 15 of every 28-day cycle. Therapy will continue until disease progression, unacceptable toxicity as a result of evofosfamide, or subject withdrawal. Assessments during evofosfamide treatment will include history, physical exam, and blood tests at each monthly visit to monitor for toxicity. Response and progression will be evaluated by whole-body PSMA PET/CT scan every 8 weeks (± 3 days) and determined using (PE)RECIST v1.1 criteria. PSA, NE markers (e.g., Serum CHGA, NSE), organ function tests (e.g., liver, kidney) and investigational liquid biopsy samples will be followed every cycle (monthly). FDG PET/CT will be performed at baseline, at 6-10 weeks from the date of signing the informed consent form (ICF), and upon progression, irrespective of treatment discontinuation or initiation of another therapy. Subjects will be followed for survival endpoints following completion of this study treatment until death.
Read the detailed description
Evofosfamide at a dose of 480 mg/m2 IV over 60 minutes on Days 1, 8 and 15 of every 28-day cycle. Additionally, subjects will receive standard-of-care castration (medical or surgical) plus ARSI. On days when both an ARSI and evofosfamide are administered, the ARSI should be administered at least 2 hours before or at least 2 hours after completion of the evofosfamide infusion. The preferred order of administration is evofosfamide administered first, with the ARSI administered at least 2 hours following the completion of evofosfamide infusion.
- Conditions
- Castration Resistant Prostate Cancer
- Being tested
- Evofosfamide
- Keywords
- CRPC, Castration Resistant Prostate Cancer, ARSIs, androgen receptor signal inhibitors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvofosfamideDrug
This study is evaluating evofosfamide in subjects with M1 CRPC who fail first-line ARSIs.
| Study group | Role | What they receive |
|---|---|---|
| Evaluating evofosfamide in subjects with M1 CRPC who fail first-line ARSIs | Experimental | After baseline molecular imaging (PSMA and fluorodeoxyglucose (FDG) PET/CT), prior to evofosfamide initiation, subjects will be encouraged to undergo biopsy of a dominant lesion: FDG-, PSMA-uptake and/or conventional imaging determined (in order, and according to feasibility). Subjects will then receive the alternate ARSI (i.e., different from the one received in first line) as per current standard practice and Provincial drug plan coverage. Additionally, subjects will receive combinatorial evofosfamide at a dose of 480 mg/m2 intravenously (IV) over 60 minutes on Days 1, 8 and 15 of every 28-day cycle. Therapy will continue until disease progression, unacceptable toxicity as a result of evofosfamide, or subject withdrawal. Assessments during evofosfamide treatment will include history, physical exam, and blood tests at each monthly visit to monitor for toxicity. Subjects will be followed for survival endpoints following completion of this study treatment until death. Receives: Drug: Evofosfamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preliminary clinical efficacy measures of evofosfamide in subjects with CRPC progressing to first-line ARSIs +/- docetaxel
Preliminary clinical efficacy measures of evofosfamide in subjects with CRPC (Castrate Resistant Prostate Cancer) progressing to first-line ARSIs (Androgen Receptor Signaling Inhibitor) +/- docetaxel will be determined. This is measured by the biochemical response rate (if the PSA (tumor marker) declined ≥50% compared to baseline). Sample(s) may be drawn with serum biochemistry sample(s).
Measured: Every 8 weeks (± 3 days) until death
Secondary outcomes (6)
Radiological (morphological and molecular) response rates
Radiologic response rates (morphologic and molecular) measured using (PE)RECIST (Response evaluation criteria in solid tumors) criteria v1.1 on prostate-specific membrane antigen (PSMA) positron emission tomography (PET)/ computerized tomography (CT).
Measured: Every 8 weeks (± 3 days) until death
Professional free survival (PFS)
PFS (progression free survival) from time of first evofosfamide treatment until biochemical [increase in PSA (tumor marker) >25% or an absolute increase of >2 ng/mL over baseline or nadir].
Measured: Every 8 weeks (± 3 days) until death
Response rate and PFS (progression free survival) to subsequent therapies (PFS2)
Radiological or clinical progression; occurrence rate and time-to-event of NEPC phenotype based on histological (e.g., small cell NEPC or adenocarcinoma with >50% staining to CHGA and/or SYP and/or NSE), clinical (e.g., development of visceral metastases without biochemical progression) or biochemical (e.g., serum CHGA level >5× and/or NSE >2× UNL); response rate and PFS2.
Measured: Every 8 weeks (± 3 days) until death
OS (overall survival)
OS (overall survival) as time from first treatment until death.
Measured: Every 8 weeks (± 3 days) until death
Changes in tumor biopsies
Toxicity rates graded by CTCAE v5.0 (Common Terminology Criteria for Adverse Events).
Measured: Every 8 weeks (± 3 days) until death
Circulating cfDNA markers in response to therapy
Circulating cfDNA markers will be determined in response to therapy via molecular analyses on pre- and during-treatment tissue and/or liquid biopsies.
Measured: Every 8 weeks (± 3 days) until death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Castration Resistant Prostate CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-institution, single-arm, open-label Phase 2 trial evaluating evofosfamide in subjects with M1 CRPC who fail first-line ARSIs.
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- ImmunoGenesis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836726
- Sponsor's protocol ID
- 24-6044
- Acronym
- EVO
- Status last verified
- Sep 2026
- First submitted
- 3 Feb 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial to Test Efficacy of Targeting Hypoxia Combined With ARSI After First-line ARSI Therapy for Castrate Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT06836726
- Acronym / sponsor ID
- EVO / 24-6044
- Conditions
- Castration Resistant Prostate Cancer
- Keywords
- CRPC, Castration Resistant Prostate Cancer, ARSIs, androgen receptor signal inhibitors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- ImmunoGenesis
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2030 (estimated)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-institution, single-arm, open-label Phase 2 trial evaluating evofosfamide in subjects with M1 CRPC who fail first-line ARSIs. In those progressing after second-line Docetaxel or deemed ineligible to it, the use of alternate ARSI remains the most common line of therapy in our Province, in keeping with recent international recommendations. After baseline molecular imaging (PSMA and fluorodeoxyglucose (FDG) PET/CT), prior to evofosfamide initiation, subjects will be encouraged to undergo biopsy of a dominant lesion: FDG-, PSMA-uptake and/or conventional imaging determined (in order, and according to feasibility). Subjects will then receive the alternate ARSI (i.e., different from the one received in first line) as per current standard practice and Provincial drug plan coverage. Additionally, subjects will receive combinatorial evofosfamide at a dose of 480 mg/m2 intravenously (IV) over 60 minutes on Days 1, 8 and 15 of every 28-day cycle. Therapy will continue until disease progression, unacceptable toxicity as a result of evofosfamide, or subject withdrawal. Assessments during evofosfamide treatment will include history, physical exam, and blood tests at each monthly visit to monitor for toxicity. Response and progression will be evaluated by whole-body PSMA PET/CT scan every 8 weeks (± 3 days) and determined using (PE)RECIST v1.1 criteria. PSA, NE markers (e.g., Serum CHGA, NSE), organ function tests (e.g., liver, kidney) and investigational liquid biopsy samples will be followed every cycle (monthly). FDG PET/CT will be performed at baseline, at 6-10 weeks from the date of signing the informed consent form (ICF), and upon progression, irrespective of treatment discontinuation or initiation of another therapy. Subjects will be followed for survival endpoints following completion of this study treatment until death.
Detailed description
Evofosfamide at a dose of 480 mg/m2 IV over 60 minutes on Days 1, 8 and 15 of every 28-day cycle. Additionally, subjects will receive standard-of-care castration (medical or surgical) plus ARSI. On days when both an ARSI and evofosfamide are administered, the ARSI should be administered at least 2 hours before or at least 2 hours after completion of the evofosfamide infusion. The preferred order of administration is evofosfamide administered first, with the ARSI administered at least 2 hours following the completion of evofosfamide infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-institution, single-arm, open-label Phase 2 trial evaluating evofosfamide in subjects with M1 CRPC who fail first-line ARSIs.
| Arm | Type | Receives |
|---|---|---|
| Evaluating evofosfamide in subjects with M1 CRPC who fail first-line ARSIs | Experimental | Drug: EvofosfamideAfter baseline molecular imaging (PSMA and fluorodeoxyglucose (FDG) PET/CT), prior to evofosfamide initiation, subjects will be encouraged to undergo biopsy of a dominant lesion: FDG-, PSMA-uptake and/or conventional imaging determined (in order, and according to feasibility). Subjects will then receive the alternate ARSI (i.e., different from the one received in first line) as per current standard practice and Provincial drug plan coverage. Additionally, subjects will receive combinatorial evofosfamide at a dose of 480 mg/m2 intravenously (IV) over 60 minutes on Days 1, 8 and 15 of every 28-day cycle. Therapy will continue until disease progression, unacceptable toxicity as a result of evofosfamide, or subject withdrawal. Assessments during evofosfamide treatment will include history, physical exam, and blood tests at each monthly visit to monitor for toxicity. Subjects will be followed for survival endpoints following completion of this study treatment until death. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- At least 18 years of age;
- Ability to understand the purposes and risks of the trial and has signed a written ICF approved by the investigator's REB;
- CRPC stage M1 based on conventional imaging (CT and/or bone scan) or PSMA PET;
- Progression (i.e., PSA rise of 25% or more, and absolute increase of 2 ng/mL or more from the nadir) to first-line ARSIs (Abi or Enza or Daro or Apa monotherapy) and subsequent docetaxel or deemed ineligible for it;
- Ongoing castration therapy (e.g., surgical or medical with LHRH agonists/antagonist), with baseline testosterone level <50ng/dL;
Key exclusion criteria (20 listed)
- 1. ANC <1,000/mm3, and/or hemoglobin <9.0 g/dL, and/or platelet count <100,000/mm3; independent of transfusion and/or growth factors 2. Liver dysfunction: total bilirubin, serum glutamic oxaloacetic transaminase (SGOT; aspartate aminotransferase [AST]) and/or serum glutamic-pyruvic transaminase (SGPT; alanine aminotransferase [ALT]) >1.5 × upper normal limit (UNL); 3. Inadequate renal function: creatinine >1.5 × UNL, or eGFR <40 mL/min; 4. Any Grade 3 or greater toxicity experienced during treatment with prior ARSI; 5. Severe, active co-morbidity defined as follows:
- 6. Known liver metastases based on conventional imaging (i.e., abdominal CT and/or MR).
- 7. Known brain, leptomeningeal or epidural metastases (unless treated, well controlled, and not requiring steroidal therapy for at least 3 months).
- 8. Major surgery (other than diagnostic surgery), open biopsy, or significant traumatic injury, ≤28 days prior to the date of signing informed consent. Subject must have completely recovered from surgery.
- 9. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EvofosfamideThis study is evaluating evofosfamide in subjects with M1 CRPC who fail first-line ARSIs. | Drug | Evaluating evofosfamide in subjects with M1 CRPC who fail first-line ARSIs |
Primary outcome
Preliminary clinical efficacy measures of evofosfamide in subjects with CRPC progressing to first-line ARSIs +/- docetaxel
Time frame: Every 8 weeks (± 3 days) until death
Preliminary clinical efficacy measures of evofosfamide in subjects with CRPC (Castrate Resistant Prostate Cancer) progressing to first-line ARSIs (Androgen Receptor Signaling Inhibitor) +/- docetaxel will be determined. This is measured by the biochemical response rate (if the PSA (tumor marker) declined ≥50% compared to baseline). Sample(s) may be drawn with serum biochemistry sample(s).
6 secondary outcomes
Radiological (morphological and molecular) response rates
Time frame: Every 8 weeks (± 3 days) until death
Professional free survival (PFS)
Time frame: Every 8 weeks (± 3 days) until death
Response rate and PFS (progression free survival) to subsequent therapies (PFS2)
Time frame: Every 8 weeks (± 3 days) until death
OS (overall survival)
Time frame: Every 8 weeks (± 3 days) until death
Changes in tumor biopsies
Time frame: Every 8 weeks (± 3 days) until death
Circulating cfDNA markers in response to therapy
Time frame: Every 8 weeks (± 3 days) until death
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Evofosfamide in people with Castration Resistant Prostate Cancer, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alejandro Berlin, MD (416-946-4501 ext. 5813, Alejandro.Berlin@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preliminary clinical efficacy measures of evofosfamide in subjects with CRPC progressing to first-line ARSIs +/- docetaxel (time frame: Every 8 weeks (± 3 days) until death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.