Tests adaptive radiotherapy for localized prostate cancer with urinary symptoms

AI summary

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 with newly diagnosed prostate cancer that has not spread, who also have urinary symptoms and/or an enlarged prostate. They would receive adaptive stereotactic radiotherapy in five weekly sessions.

Age

18 years or older

Sex

Men only

Disease stage

Prostate cancer confirmed by tissue test, not spread (no lymph node or distant metastases), intermediate to high risk (up to cT3a, Gleason score up to 9 and/or PSA up to 20 ng/ml). Seminal vesicle involvement (cT3b) is not allowed.

Earlier treatment

No earlier radiotherapy to the pelvis or the prostate. Planned treatment is CT or MRI online adaptive SBRT of the prostate, as standard care.

Biomarker or test result

Prostate volume above 60 cc and/or IPSS score above 12

Main reasons for not taking part

• Very high risk cancer needing hormone therapy (ADT and ARPI), for example Gleason 8 or higher with cT3a
• Cancer in the seminal vesicles (cT3b)
• Inflammatory bowel disease, earlier pelvic or prostate radiotherapy, or no possibility to have MRI or CT
• Severe urinary symptoms, such as recent urinary retention of grade 3 or higher
• Lymph node or distant metastases

The registry criteria, word for word

What the trial wants to find out

The aim of this phase II international multicenter study is to evaluate the safety, feasibility, and efficacy of CT or MRI-adaptive SBRT, delivered in five weekly fractions, in patients with newly diagnosed localized prostate cancer who have lower urinary tract symptoms and/or prostatic hyperplasia.

The 2 groups in the trial

• Pilot study

  For our pilot study, we assumed that around 3% of patients would have grade 3 acute urogenital toxicity (i.e. 1 patient). The rate of treatment discontinuation within 3 months was considered negligible. Our aim was to show with high probability, that the event rate was below a clinically acceptable threshold, which was set at 20%. Under the null hypothesis, this design with an alpha of 0.05 and power of 80% results in an expected number of cases of 30. Dropouts prior to treatment start will be replaced.

  Treatment: radiotherapy

• Validation Cohort

  For our validation study, we assume that around 3% of patients will have grade 3 long-term urogenital toxicity (i.e. 2 patients). The rate of treatment discontinuation within 3 months is considered negligible. Our aim is to show with high probability, that the event rate is below a clinically acceptable threshold, which is set at 12%. Under the null hypothesis, this design with an alpha of 0.05 and power of 80% results in an expected number of cases of 75. Dropouts prior to treatment start will be replaced.

  Treatment: radiotherapy