A Randomised, Double‑Blind, Placebo‑Controlled, 2‑Cohort, Phase III Study of Saruparib Combined with Physician’s Choice of Androgen Receptor Pathway Inhibitor in Patients With Metastatic Hormone‑Sensitive Prostate Cancer, Previously Treated With Docetaxel or PSMA‑directed 177Lutetium‑Containing Therapy Without Disease Progression, and With Prostate‑Specific Antigen ≥ 0.2 ng/mL: EvoPAR Prostate‑05
This Phase 3 clinical trial is looking at a new medicine called saruparib for men with advanced prostate cancer that has spread to other parts of the body (metastatic prostate cancer). The trial focuses on cancer that still responds to hormone therapy and has already been treated with chemotherapy (docetaxel) or targeted radiation therapy without worsening. Researchers want to see if adding saruparib to standard hormone treatments works better than standard treatments alone. Half of the participants will receive saruparib tablets, while the other half will receive dummy tablets (a placebo), alongside their usual hormone therapy. Doctors will monitor participants using scans and blood tests to see if the new medicine slows down cancer growth, protects bones, and helps people live longer, healthier lives.
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¿De qué trata este estudio?
Prostate cancer is one of the most common cancers in men. Sometimes, cancer cells spread from the prostate to other areas, such as the bones or lymph nodes. When the cancer still responds to treatments that lower testosterone—the male hormone that can fuel cancer growth—it is known as hormone-sensitive prostate cancer. Standard care often involves hormone-blocking medicines combined with chemotherapy or targeted radiation.
This study, called EvoPAR Prostate-05, is testing whether adding an experimental tablet called saruparib can improve standard care. Saruparib is designed to block certain proteins that cancer cells rely on to repair their DNA. By stopping these repairs, the drug aims to slow down or halt the growth of cancer cells.
Taking part in this study helps researchers find out if combining saruparib with standard hormone therapy keeps cancer from growing for longer compared to standard therapy alone. It also looks at whether this approach helps protect bones from cancer damage and improves overall survival for men living with advanced prostate cancer.
Puntos clave
- The study tests whether adding saruparib to standard hormone therapy slows advanced prostate cancer.
- It is for men whose cancer has spread but still responds to hormone treatments.
- Participants must have completed chemotherapy or PSMA radiation without their cancer worsening.
- Half of the men receive saruparib and half receive a dummy tablet (placebo), alongside standard therapy.
- Participation includes regular clinic visits, blood tests, and imaging scans to track your health.
¿Quién puede ser elegible?
This trial is for men aged 18 and older who have prostate cancer that has spread to other parts of the body but still responds to hormone treatments. To join, your prostate-specific antigen (PSA) blood level must be at least 0.2 ng/mL.
You must have already finished treatment with either a chemotherapy drug called docetaxel or a targeted radioactive therapy (177Lutetium-PSMA), and your cancer must not have grown or worsened during that treatment.
Because this is a clinical trial, there are detailed medical rules about your general fitness, organ function, and previous medications. The study team will review your full medical history and perform tests to see if taking part is safe for you.
¿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.
- I am a man aged 18 or older.
- I have prostate cancer that has spread to other parts of my body.
- My cancer still responds to hormone therapy.
- I have had previous treatment with docetaxel chemotherapy or PSMA targeted radiation.
- My cancer did not get worse during my previous chemotherapy or radiation treatment.
- My current PSA blood test level is 0.2 ng/mL or higher.
¿En qué consiste la participación?
If you take part, you will be placed into one of two groups by chance (like flipping a coin). One group will take saruparib tablets every day, while the other group will take matching dummy tablets (placebos). Neither you nor your doctor will know which group you are in, but both groups will receive standard hormone therapy chosen by your doctor.
You will need to visit the hospital clinic regularly for routine health checks. These visits will include blood tests to check your PSA levels and organ health, physical exams, and regular scans (such as CT, MRI, or bone scans) to see how the cancer is responding.
You will continue taking the trial tablets for as long as the treatment keeps your cancer stable and you do not experience troublesome side effects. If you stop taking the trial medication, the team will continue to check on your health through periodic clinic visits or phone calls.
Riesgos y beneficios potenciales
Ubicaciones (4)
- —No verificadoFrancia
- —No verificadoAlemania
- —No verificadoEspaña
- —No verificadoItalia
Preguntas comunes
¿Qué es un placebo?
A placebo is a dummy tablet that looks identical to the real trial medicine but contains no active ingredients. It helps doctors fairly measure whether the new drug genuinely works.
Will I miss out on standard cancer treatment?
No. Everyone in the trial receives standard hormone therapy. Saruparib or the placebo is given in addition to your standard care.
Why do I need to take part if my cancer is stable?
The goal is to find treatments that can keep the cancer under control for as long as possible before it starts growing again.
How often will I need scans?
You will have regular imaging scans, usually every few months, so the doctors can clearly see if your cancer is staying stable or changing.
¿Puedo abandonar el estudio si cambio de opinión?
Yes. You have the right to withdraw from the trial at any time, for any reason, without your future medical care being affected.
Cómo obtener más información
Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.
Discusión
Discusión comunitaria
Impulsado por nuestro foro en community.patient.info. Por favor, sea respetuoso — esto no es un consejo médico.