BridgeMD
New treatment option for Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Official title Combination Study of Antibiotics With Enzalutamide (PROMIZE)
ClinicalTrials.gov ID: NCT06126731
What this study is testing
What is Enzalutamide 40mg?
Enzalutamide 40mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for metastatic castration-resistant prostate cancer (mcrpc).
Also referred to as Xtandi.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- PROMIZE is an open-label, multi-centre, single-arm, Phase I/II clinical trial, evaluating the safety, tolerability and anti-tumuor efficacy of an antibiotic combination and enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Histologically or cytologically proven metastatic castration-resistant prostate cancer or adenocarcinoma refractory to conventional treatment, or for...
- Documented prostate cancer progression as assessed by the investigator with RECIST (v1.1) and PCWG3 criteria with at least one of the following...
- Progression of soft tissue/visceral disease by RECIST (v1.1) and/or,
- Progression of bone disease by PCWG3 bone scan criteria and/or,
- Progression of PSA by PCWG3 PSA criteria and/or
You likely can't join if
- Surgery, radiotherapy, chemotherapy, or other anti-cancer therapy within 4-weeks prior to trial entry into the study (6 weeks for bicalutamide). The...
- Patients receiving enzalutamide immediately preceding the trial will be able to continue on enzalutamide without washout.
- Prior flutamide treatment during previous 4-weeks. N.B. Patients whose PSA did not decline in response to antiandrogens given as a second line or...
- Prior bicalutamide (Casodex) and nilutimide (Nilandron) treatment during previous 6-weeks;
- Prior progesterone, medroxyprogesterone, progestins, cyproterone acetate, tamoxifen, and 5-alpha reductase inhibitors during previous 2-weeks...
- Ongoing toxic manifestations of previous treatments. Exceptions to this are alopecia or certain Grade 1 toxicities, which in the opinion of the...
See the full eligibility criteria
Who can join
- Histologically or cytologically proven metastatic castration-resistant prostate cancer or adenocarcinoma refractory to conventional treatment, or for which no conventional therapy exists or is declined by the patient.
- Documented prostate cancer progression as assessed by the investigator with RECIST (v1.1) and PCWG3 criteria with at least one of the following criteria:
- Progression of soft tissue/visceral disease by RECIST (v1.1) and/or,
- Progression of bone disease by PCWG3 bone scan criteria and/or,
- Progression of PSA by PCWG3 PSA criteria and/or
- Clinical progression with worsening pain and need for palliative radiotherapy for bone metastases.
- Phase I: Patients that have progressed after at least 12 weeks of treatment with a NAAT within the previous 6 months Phase II: Patients that have progressed after at least 12 weeks of treatment with a NAAT within the...
- Previously progressed on at least one line of taxane chemotherapy (or not fit or not willing to receive a taxane).
- Ongoing androgen deprivation maintaining serum testosterone of less than 50 ng/dL (less than 2.0 nM) is mandatory.
- Life expectancy of at least 12-weeks.
- Able to swallow tablets.
- Archival tumour tissue must be available for analyses.
- Willing to have pre- and post-treatment biopsies if biopsy is feasible.
- World Health Organisation (WHO) performance status of 0-2 (Appendix 1).
- Haematological and biochemical indices within the ranges shown below. These measurements must be performed within one week (Day -7 to Day 1) prior to the patient's first dose of IMP. Haemoglobin (Hb): ≥ 9.0 g/dL...
- 18 years or over
- Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up
- Willing and able to comply with the study requirement including the collection of blood, fresh tumour biopsy, urine, rectal swab and stool samples.
What rules you out
- Surgery, radiotherapy, chemotherapy, or other anti-cancer therapy within 4-weeks prior to trial entry into the study (6 weeks for bicalutamide). The use of bisphosphonates or RANK ligand inhibitors in patients with...
- Patients receiving enzalutamide immediately preceding the trial will be able to continue on enzalutamide without washout.
- Prior flutamide treatment during previous 4-weeks. N.B. Patients whose PSA did not decline in response to antiandrogens given as a second line or later intervention will only require a 14-day washout;
- Prior bicalutamide (Casodex) and nilutimide (Nilandron) treatment during previous 6-weeks;
- Prior progesterone, medroxyprogesterone, progestins, cyproterone acetate, tamoxifen, and 5-alpha reductase inhibitors during previous 2-weeks (14-days).
- Ongoing toxic manifestations of previous treatments. Exceptions to this are alopecia or certain Grade 1 toxicities, which in the opinion of the Investigator and the DDU should not exclude the patient.
- Previous treatment with any systemic antibiotic within 12 weeks of study entry.
- Known hypersensitivity reaction or intolerance to any penicillin, amoxicillin, metronidazole, vancomycin, ciprofloxacin or enzalutamide.
- History of tendon disorder secondary to quinolones
- Use of drugs that are listed in the prohibited concomitant medications section including strong inducers and inhibitors of CYP450 (please refer to http://medicine.iupui.edu/clinpharm/ddis/table.aspx). Seville orange or...
- Concurrent treatment with prohibited medications which include medications that causes ototoxicity, neurotoxicity, and nephrotoxicity.
- Known or suspected leptomeningeal metastases or untreated brain metastasis. Patients with brain metastases that have been treated and have been shown to be radiologically stable for more than 6 months may be considered...
- History of stroke, epilepsy or current excessive alcohol intake. History of clinically significant hearing loss including but not limited to congenital hearing loss, need for hearing aids, ongoing acute or chronic ear...
- History of clinically significant hearing loss including but not limited to congenital hearing loss, need for hearing aids, ongoing acute or chronic ear infection, history of tympanic membrane perforation, tinnitus...
- Patients with partners of child-bearing potential (unless they agree to use a barrier method of contraception [condom plus spermicide] or to sexual abstinence effective from the first administration of any of the...
- Any condition that would increase enteral absorption in the opinion of the investigator, including but not limited to malabsorption syndromes, impaired GI motility, chronic pancreatitis, partial or complete gastric...
- At high medical risk because of non-malignant systemic disease including active uncontrolled infection.
- Clinically significant history of liver disease consistent with Child-Pugh Class B or C, including viral or other hepatitis, current alcohol abuse, or cirrhosis.
- Known to be serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
- Any of the following cardiac criteria:
- Clinically important abnormalities including rhythm, conduction or ECG changes (left bundle branch block, third degree heart block).
- Factors predisposing to QT prolongation including congenital long QT syndrome; family history of prolonged QT syndrome, unexplained sudden death (under 40); concomitant medications known to prolong QT interval.
- Concurrent congestive heart failure, prior history of class III/ IV cardiac disease (New York Heart Association [NYHA] - refer to Appendix 5), prior history of cardiac ischaemia or prior history of cardiac arrhythmia.
- QTcF (corrected using Fredericia formula) of ≥460 ms.
- Prior bone marrow transplant or have had extensive radiotherapy to greater than 25% of bone marrow within eight weeks.
- Active or uncontrolled autoimmune disease requiring corticosteroid therapy or other forms of systemic immunosuppression.
- Patient is a participant or plans to participate in another treatment clinical trial, whilst taking part in this study. Participation in an observational trial would be acceptable.
- Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial.
- Malignancy other than prostate cancer within 3-years of trial entry with the exception of adequately treated basal cell carcinoma. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy...
- Symptoms of COVID-19 and/or current documented COVID-19 infection.
The study team makes the final eligibility decision.
Where it's taking place
- Bellinzona, Switzerland
- Sutton, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bellinzona, Switzerland; Sutton, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.