TherApeutics in Early ProState Cancer (TAPS02)
This study, called TAPS02, is for men with early prostate cancer who are currently being monitored closely (active surveillance). We're testing a drug called apalutamide, also known as Erleada, which is given as a tablet. The main goal is to see if taking this medication for a short time can be a helpful addition to active surveillance. Participants will be randomly assigned to receive either apalutamide or a dummy pill (placebo), and neither they nor their doctors will know which one they're taking. This allows us to fairly compare the effects of the drug. The study is open to men aged 18 and over who meet specific health and cancer criteria.
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¿De qué trata este estudio?
Imagine you've been diagnosed with early prostate cancer, and your doctors have recommended 'active surveillance.' This means they're keeping a very close eye on your cancer without immediate treatment, only stepping in if it changes or grows. This approach is often chosen when the cancer is slow-growing and not causing symptoms.
This study is called TAPS02, and it's looking into whether adding a short course of medication could be beneficial for men like you. The drug being tested is called apalutamide, also known by its brand name Erleada. It's a tablet that works by affecting hormones that can fuel prostate cancer growth. The researchers want to understand if taking this drug for a limited time can make active surveillance even more effective.
This is a 'Phase 2' study, which means it builds on earlier research and aims to see how well the drug works and if it's safe in a larger group of people. By comparing apalutamide to a dummy pill (placebo), the doctors can get a clear picture of what effect, if any, the drug has. The information from this study could help doctors decide if this type of short-term treatment should be offered more widely to men on active surveillance in the future.
Puntos clave
- This study is for men with early prostate cancer on active surveillance.
- It tests a drug called apalutamide (Erleada) against a dummy pill (placebo).
- Participation involves taking tablets and having regular check-ups.
- The aim is to see if short-term treatment can improve prostate cancer management.
- You won't know if you're getting the active drug or the placebo.
- You can leave the study at any time without affecting your care.
¿Quién puede ser elegible?
To join this study, you need to be a man aged 18 or older. You should already be on active surveillance for your prostate cancer, meaning your doctors are carefully watching it without giving you immediate treatment.
Your cancer needs to meet certain criteria, including showing up on an MRI scan and being confirmed by biopsies. You also need to be generally in good health, with certain blood test results within a healthy range. Importantly, you shouldn't be expected to need bladder surgery in the near future.
Your doctor will need to check your full medical history and perform some tests to make sure you fit all the requirements for the study. If you're interested, discussing it with your healthcare team is the first step.
¿Podría este estudio ser adecuado para ti?
Responde estas preguntas rápidas para ver si puedes ser elegible. Esto es solo una guía: el equipo de investigación toma la decisión final.
- ¿Eres un hombre de 18 años o más?
- Are you currently on active surveillance for prostate cancer?
- Has your doctor confirmed your cancer meets specific study criteria (e.g., from MRI/biopsy)?
- Are you generally in good health, without major other health conditions?
- Are your recent blood tests (like blood counts, kidney, and liver function) within normal limits?
¿En qué consiste la participación?
If you decide to take part in this study, you'll first be asked to sign a consent form, making sure you understand everything involved. You'll have regular hospital visits for check-ups, blood tests, and scans. You'll be given either the study drug, apalutamide, or a dummy pill (placebo) to take regularly, as prescribed by the study team. Neither you nor your doctor will know which you are receiving, which helps make the study results fair.
The study treatment period and follow-up will involve a series of appointments over a period of time. The exact number and frequency of visits will be explained by the study team, but they will be spread out to monitor your health and the progress of your cancer and to check for any side effects. You'll receive clear instructions on how to take your medication and what to expect at each appointment. The total duration of your involvement will be clearly outlined.
Riesgos y beneficios potenciales
Ubicaciones (6)
- Hospital AddenbrookeCódigo postal verificadoCambridge, Reino Unido· Reclutamiento
- Hospital SouthmeadCódigo postal verificadoBristol, Reino Unido· Reclutamiento
- Hospital West SuffolkCódigo postal verificadoBury St Edmunds, United Kingdom· Reclutamiento
- Hospital Darent ValleyCódigo postal verificadoDartford, United Kingdom· Reclutamiento
- St Bartholomew's HospitalCódigo postal verificadoLondres, Reino Unido· Reclutamiento
- The Royal Marsden Hospital - ChelseaCódigo postal verificadoLondres, Reino Unido· Reclutamiento
Preguntas comunes
What is 'active surveillance'?
Active surveillance means your doctors are closely watching your prostate cancer with regular tests, but not giving you immediate treatment unless it shows signs of getting worse.
What is apalutamide (Erleada)?
It's a tablet medicine that works by blocking hormones that can cause prostate cancer to grow. It's being tested to see if it can help men on active surveillance.
Will I know if I'm getting the drug or a dummy pill?
No, during the study, neither you nor your doctor will know if you're taking apalutamide or a dummy pill (placebo). This helps make the study results as accurate as possible.
What does a 'Phase 2' study mean?
A Phase 2 study checks how well a new treatment works and if it's safe for people. It's a step before potentially offering the treatment more widely.
What are the main requirements to join?
You need to be a man aged 18 or over, on active surveillance for prostate cancer that fits certain criteria, and generally in good health with specific blood test results.
Cómo obtener más información
Elizabeth Young
Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.
¿Interesado en participar?
Discusión
Discusión comunitaria
Impulsado por nuestro foro en community.patient.info. Por favor, sea respetuoso — esto no es un consejo médico.