AuthorisedTherapeutic confirmatory (Phase III)Interventional

Stereotactic body radiation therapy on Prostate with or without Androgen deprivation therapy, a phase III randomized controlled trial (SPA Trial)

This study is a research trial for men with a specific type of prostate cancer called acinar cell prostatic carcinoma. It aims to find out if combining a special type of radiation therapy, called stereotactic body radiation therapy (SBRT), with hormone therapy works better than SBRT alone. SBRT delivers high doses of radiation to the prostate over fewer sessions. Hormone therapy (using medicines like Decapeptyl and Casodex) aims to reduce the male hormones that can fuel prostate cancer growth. Researchers will compare how well the cancer is controlled and if it returns or spreads in both groups of patients. This is a Phase III trial, meaning it's a key step in seeing if this combined treatment could become a standard option.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia, Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

Enrolment target

310

Start

31 Jan 2025

Acinar cell prostatic carcinoma

What is this study about?

This research study, called the SPA Trial, is looking into treating a type of prostate cancer called acinar cell prostatic carcinoma. The main goal is to find the best way to stop the cancer from coming back after treatment. We’re comparing two different approaches. Everyone in the study will receive a modern type of radiation therapy called stereotactic body radiation therapy (SBRT), which delivers precise, high doses of radiation to the prostate.

What makes the two groups different is whether they also receive hormone therapy. One group will get SBRT combined with hormone therapy, which involves medicines like Decapeptyl and Casodex that help lower male hormone levels. The other group will receive SBRT on its own. Doctors want to see if adding hormone therapy makes the radiation treatment more effective at keeping the cancer under control.

The study will carefully track how well the treatments work. They will look at whether certain blood test results (like PSA levels) stay low, which suggests the cancer is not returning. They'll also check if the cancer comes back in the prostate, nearby areas, or if it spreads to other parts of the body. Ultimately, the aim is to find out if one treatment approach is significantly better at preventing the cancer from returning, helping men live longer and healthier lives.

Key takeaways

This study compares radiation alone vs. radiation plus hormone therapy for prostate cancer.
It uses a precise radiation called SBRT and hormone medicines like Decapeptyl and Casodex.
The main aim is to see which treatment best prevents the cancer from returning.
Participation involves receiving treatment and having regular check-ups.
This is a Phase III study, a critical step in testing new treatments.
You can withdraw from the study at any time.

Who may be eligible?

This study is open to adult men who have been diagnosed with a specific type of prostate cancer called acinar cell prostatic carcinoma. You must be at least 18 years old to take part; there's no upper age limit.

To be eligible, you'll need to meet several other health criteria that the study doctors will check. These are to make sure the treatment is safe for you and that the study results are clear. Your doctor will discuss all the details to determine if this study is a good fit for you.

It's important to remember that only men who fit all the specific criteria for the study can participate. This ensures that the research can accurately compare the treatments for the intended group of patients.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult male?
Have you been diagnosed with acinar cell prostatic carcinoma?
Are you aged 18 years or older?
Are you able to commit to the study's treatment and follow-up plan?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be assigned to one of two treatment groups, like flipping a coin – it's a random choice. Both groups will receive a special type of radiation treatment called SBRT (stereotactic body radiation therapy). One group will also receive hormone therapy, which involves injections and pills. The other group will just receive the SBRT.

You'll have regular appointments for your treatments, blood tests, and scans to check how you're doing and whether the treatment is working. The study staff will explain the full schedule of visits, which will include monitoring your PSA levels and checking for any signs of the cancer returning or spreading. The total duration of your participation in the study, including follow-up, will be clearly explained by the research team.

Potential risks and benefits

Participating in this study might offer you access to a new treatment combination that could be more effective for your prostate cancer than standard care. However, there are potential risks, as with any medical treatment, including possible side effects from the radiation therapy or the hormone therapy, which will be fully explained by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy

Common questions

What is SBRT?

SBRT stands for Stereotactic Body Radiation Therapy. It's a very precise way to deliver a high dose of radiation to the prostate in fewer treatment sessions compared to traditional radiation.

What is hormone therapy?

Hormone therapy for prostate cancer uses medicines to lower the levels of male hormones in your body, which can help slow down or stop the growth of cancer cells.

What does 'Phase III' mean?

Phase III is a stage of clinical trial where a new treatment is compared to existing treatments or a placebo, often involving a larger group of people, to see if it's safe and more effective.

What is PSA?

PSA stands for Prostate-Specific Antigen. It's a protein made by the prostate, and doctors measure its level in your blood. High or rising levels can sometimes mean prostate cancer is present or returning.

What if I wanted to stop taking part?

You are free to leave the study at any time, for any reason. Your decision will not affect your future medical care or your relationship with your doctors.