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RecruitingLast updated: 7 February 2024

PETRANHA: This phase I/II study is evaluating how safe and effective a new targeted therapy (AZD5305) when given in combination with new hormonal agents (enzalutamide, abiraterone acetate or darolutamide) in people with metastatic prostate cancerA Multi-arm, Open-label Phase I/IIa Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of AZD5305 in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer (PETRANHA)

Clinical summary

Summary

Approximately 140 people will be enrolled and screening to ensure that up to approximately 126 evaluate patients can be assigned to study treatments across all three study arms. Eligible participants will be non-randomly assigned two one of three experimental arms. In Experimental Arm 1, participants will receive an oral dose of AZD5305 and oral dose of Enzalutamide once daily. In Experimental Arm 2, participants will receive an oral dose of AZD5305 and an oral dose of Abiraterone Acetate once daily. In Experimental Arm 3, participants will receive an oral dose of AZD5305 once daily and an oral dose of Darolutamide twice daily.

Conditions

This trial is treating patients with metastatic prostate cancer

Cancer

Urinary System Cancers Genitourinary

Age

People18 - 130

Phase

I/II

Trial Acronym

PETRANHA

More information

Trial Identifiers

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Trial sponsor

AstraZeneca

Scientific Title

A Multi-arm, Open-label Phase I/IIa Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of AZD5305 in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer (PETRANHA)

Eligibility

Inclusion

For whole study:

  • Age ≥ 18 at the time of screening.
  • Histologically confirmed diagnosis of metastatic prostate cancer.
  • Candidate for treatment with enzalutamide, abiraterone acetate, or darolutamide with documented current evidence of metastatic prostate cancer.
  • Surgically or medically castrated.
  • Adequate organ and marrow function.
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS): 0-1 with no deterioration over the previous 2 weeks.
  • Life expectancy ≥ 16 weeks.
  • Non-sterilized male patients who are sexually active with a female partner of childbearing potential must use a condom with spermicide from screening to approximately 6 months after the last dose of study treatment .

For Patients Recruited Specifically to tumour Pharmacodynamic Cohorts:

• Patients must have at least 1 tumour suitable for paired biopsies

For Part A:

• Patients with Metastatic Castrate ion-Resistant Prostate Cancer (mCRPC) or Metastatic Castration Sensitive Prostate Cancer (mCSPC).

For Part B:

• Patients must have mCSPC (de novo or recurrent) with a baseline PSA value of ≥ 0.2 ng/mL

Exclusion

For Part A mCRPC patients only:

  • Any previous treatment with a poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitor, Lu-PSMA, platinum chemotherapy
  • Patients recruited to the PDc cohorts should not have received a prior use of new hormonal agents (NHA).

For Part A and Part B mCSPC Patients:

  • Any previous treatment with a PARP inhibitor, platinum, NHA, Immuno-oncology (IO), radiopharmaceutical therapy, or prior treatment with docetaxel in mCSPC setting.
  • Concomitant use of medications or herbal supplements known to be:

    1. Strong and moderate CYP3A4 inducers/inhibitors (applies for all arms)
    2. For Arm 1 (enzalutamide) patients: Strong CYP2C8 inhibitors
    3. For Arm 3 (darolutamide) patients: Strong P-glycoprotein inducers
  • Concomitant use of drugs that are known to prolong or shorten QT and have a known risk of Torsades de Pointes.
  • Treatment with any of the following:

    1. Any investigational agents or study interventions from a previous clinical study within 5 half lives or 3 weeks (whichever is longer) of the first dose of study treatment.
    2. Any other anticancer treatment within the following time periods prior to the first dose of study treatment: (i) Cytotoxic and non-cytotoxic treatment: 3 weeks or 5 half-lives (whichever is shorter). (ii) Biological products including immuno-oncology agents: 4 weeks before enrolment.
    3. Any live virus or bacterial vaccine within 28 days of the first dose of study treatment.
  • Any concurrent anticancer therapy or concurrent use of prohibited medications.
  • Major surgery within 4 weeks prior to the first dose of study treatment.
  • Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study treatment.
  • With the exception of alopecia, and peripheral neuropathy; any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at the time of study enrolment.
  • Any history of persisting (> 2 weeks) severe pancytopenia.
  • Spinal cord compression, or brain metastases unless asymptomatic and treated and stable.
  • Any evidence of severe or uncontrolled systemic diseases, including, active bleeding diatheses, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
  • Patients with any known predisposition to bleeding (eg, active peptic ulceration, recent [within 6 months] haemorrhagic stroke, proliferative diabetic retinopathy.
  • Any clinically significant cardiac disorders including QT prolongation, abnormal electrocardiogram (ECG).
  • Any clinically significant cardiovascular diseases including symptomatic heart failure, uncontrolled hypertension, acute coronary syndrome, cardiomyopathy, valvular heart disease, atrial fibrillation, stroke.
  • Patients with history of myelodysplastic syndrome (MDS)/ acute myeloid leukaemia (AML).
  • Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection.
  • Known allergy or hypersensitivity to investigational product(s) or any of the excipients of the investigational product(s).
  • Any condition that would interfere with evaluation of the study treatment or interpretation of patient safety or study results.
  • Uncontrolled intercurrent illness within the last 12 months, including but not limited to, active interstitial lung disease, serious chronic gastrointestinal (GI) conditions associated with diarrhoea, or psychiatric illness/social situations
  • History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before the first dose of study treatment and of low potential risk for recurrence.
  • Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
  • Arm 1 (Enzalutamide) only: History of seizure or any condition that may predispose to seizure (eg, prior cortical stroke, significant brain trauma).
  • Arm 2 (Abiraterone acetate) only: (i) Active infection or other medical condition that would contraindicate the use of systemic steroids (prednisone/prednisolone). (ii) Low serum potassium (< 3.5 mmol/L). (iii) History of uncontrolled pituitary or adrenal dysfunction.

Inclusion

  • You are able to swallow medication by mouth.
  • You have had a certain type of treatment or surgical procedure.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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