EnzAdapt: A clinical trial for men with prostate cancer that has spread, testing a new way of taking a standard medicine

Phase 1

Recruiting

• Conditions: Prostate cancer; castrate resistant prostate cancer; Cancer - Prostate

• Registration Number: ACTRN12619000567123
• Lead Sponsor: Calvary Mater Newcastle

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-11
• Last Update Posted: 21 September 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 15

Inclusion Criteria

Participants are eligible to be included in the study only if all of the following criteria apply:
·Histologically or biochemically confirmed adenocarcinoma of the prostate
·Ongoing androgen deprivation therapy with a GnRH analogue or bilateral orchiectomy (i.e., surgical or medical castration with testosterone at screening <0.5 ng/L)
oPatients who have not had a bilateral orchiectomy, must have a plan to maintain effective GnRH-analogue therapy for the duration of the trial;
·Metastatic castration resistant prostate cancer (CRPC)
·Prior treatment with taxane chemotherapy, (e.g. docetaxel and/or cabazitaxel) or predicted to be intolerant and not eligible for future chemotherapy
·Controlled symptoms (opioids for cancer related pain stable for > 4 weeks, no need for urgent radiotherapy for symptomatic lesions)
·Metastatic disease defined as at least 1 documented metastatic lesion on either a whole body bone scan or a CT scan of the chest, abdomen and pelvis.
·Participant has chosen to take enzalutamide as standard of care treatment for CRPC

Exclusion Criteria

·Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrolment;
·Known or suspected brain metastasis or active leptomeningeal disease;
·Any other therapies for CRPC (excluding denosumab) to be discontinued 3 weeks prior to study.
·Prior treatments with CYP17 or androgen receptor inhibitors (abiraterone or enzalutamide prior to this course). Prior treatment with docetaxel or cabazitaxel is allowed.
·Documented liver metastases

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Tolerability and acceptability of adaptively dosed enzalutamide will be defined as the number of men that are able to complete at least 3 adaptive loops of treatment divided by the number of men that are enrolled on study[The outcome of the study will be assessed at the time of the end of the third adaptive loop of treatment in the last patient enrolled on study]

Secondary Outcome Measures

Name	Time	Method
2. Safety as defined by adverse events (CTCAE v5.0)<br><br><br>[2. Continuous during study treatment and for 30 days after the end of treatment<br>];3. Efficacy of adaptively dose enzalutamide will be as defined as the frequency of PSA response/re-response after enzalutamide re-introduction in each loop; i.e the frequency of adaptive loops in each man on study where the PSA falls by 50%<br>[3. PSA blood tests will be taken every month];4. Efficacy as defined by radiological response per PCWG3 criteria<br>[4. Three monthly CT and bone scans until end of treatment or end of study];5. Efficacy as defined by median time to on-treatment failure on enzalutamide defined by PCWG3 criteria[5. At each treatment loop, each 3 monthly scan or at end of study]