Testing a dose of BP-C2 alongside hormone treatment for prostate cancer
Tests an oral dose of BP-C2 with hormone treatment in men with prostate cancer.
Plain-language title generated from the registry record
Registry title: Recommended Dose Estimation of BP-C2
Key facts
- Where
- Skjetten, NorwaySee the site
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men aged 18 to 80 with prostate cancer who are already having hormone treatment. It tests an oral dose of BP-C2 added to that treatment.
- Age
- 18 to 80 years
- Sex
- Men only
- Disease stage
- Prostate cancer. The record does not name a stage.
- Earlier treatment
- Must be having hormone treatment now. Cannot be having radiotherapy now. Cannot have taken corticosteroids or other immunosuppressive drugs in the last 3 weeks. Cannot have been in another drug trial in the last six weeks.
Main reasons for not taking part
- Expected survival below 3 months
- Abnormal liver function (total bilirubin >34 µmol/l or ALAT >3 times the upper normal range)
- Abnormal kidney function (serum creatinine >120 µmol/l (1.36 mg/dL))
- Proven cancer spread to the brain
- Another cancer at the same time, except non-melanoma skin cancer and early cervical cancer
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT04186585, who can take part
Where in Norway
- MeddocSkjetten, NorwayTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Meddoc
- Trial code
- NCT04186585
- Record updated
- 9 May 2025
- Original description
The aim is to estimate an oral administered recommended dose of BP-C2 in addition to hormone treatment of prostate cancer.Read full original descriptionShow less
Recommended Dose Estimation of BP-C2 in Patients With Prostate Cancer: A Phase I Dose-finding Study.
The aim is to estimate an oral administered recommended dose of BP-C2 in addition to hormone treatment of prostate cancer.
The study population consists of prostatic cancer patients between 18 and 80 years of age undergoing hormonal treatment. Four patients will be recruited consecutively from each of two participating hospital.
The study will be performed as an open, one-dimensional multi-center trial with a 3-level within-patient Response Surface Pathway (RSP) design.
Inclusion: Prostate cancer patients between 18 and 80 years of age under hormonal treatment.
Exclusion: Under radiological therapy; Under systemic treatment with corticosteroids or other immunosuppressive drugs the last 3 weeks before start of the trial treatment; Participating in another clinical trial with pharmaceuticals the last six weeks before start of this trial treatment; Synchronous cancer except for non-melanoma skin cancer and early stage of cervical cancer; Abnormal liver function classified as total bilirubin >34 µmol/l or ALAT > 3 times the upper normal range (ULN). In case of metastases in the liver, the ALAT limit for exclusion is set to 5 x ULN; Abnormal kidney function defined by serum creatinine >120 µmol/l; Patients with expected survival time below 3 months; Patients with verified metastasis to the brain; Clinically significant abnormal ECG; Not able to understand information; Do not want or not able to give written consent to participate in the study.