PSMA-PET Guided Hypofractionated Salvage Prostate Bed Radiotherapy

Launched by UNIVERSITY MEDICAL CENTER GRONINGEN · Nov 17, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating a new way to treat prostate cancer that has returned after surgery. After men have a radical prostatectomy (surgery to remove the prostate), some may experience a biochemical recurrence, which means the cancer could be returning. The standard treatment is a form of radiation therapy called salvage external beam radiation therapy (sEBRT), which aims to control the disease. The trial is comparing two different radiation treatment plans: one is the standard approach, delivering a total of 70 Gy in 35 sessions over about 7 weeks, and the other is a newer method that gives a total of 60 Gy in just 20 sessions over 4 weeks. The goal is to see if the faster treatment can help patients live longer without their cancer progressing for at least 5 years.

To participate in this trial, men aged 18 to 80 who have had a radical prostatectomy and have a specific type of prostate cancer may be eligible. They should have a rising PSA level (a blood test that indicates cancer activity) but no signs of spread to lymph nodes or other areas. Participants will be randomly assigned to one of the two treatment groups and can expect regular follow-ups to monitor their health and the effectiveness of the treatment. Overall, this study aims to improve treatment outcomes for men facing cancer recurrence after surgery, and it is currently recruiting participants.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Patients with prostate adenocarcinoma treated with radical prostatectomy;
• • Tumour stage pT2-4, R0-1, pN0, or cN0, cNx according to the UICC TNM 2009, only with Gleason score available;
• • No lymph node or distant metastases. A recent PSMA-PET scan (\< 60 days) without evidence of lymph node or distant metastases;
• • PSA progression after prostatectomy defined as two consecutive rises with the final PSA \> 0.1 ng/mL or 3 consecutive rises. The first value must be measured at least 6 weeks after radical prostatectomy;
• • PSA at inclusion \< 1.0 ng/mL;
• • WHO performance status 0-2 at inclusion;
• • Age at inclusion between 18 and 80 years;
• • Written (signed and dated) informed consent prior to registration.
• Exclusion Criteria:
• • Prior pelvic irradiation, (chemo)hormonal therapy or orchiectomy;
• • Previous or concurrent active invasive cancers other than superficial non-melanoma skin cancers;
• • Patients with positive nodes or with distant metastases based on the surgical specimen of lymphadenectomy or the following minimum diagnostic workup: PSMA-PET/CT scan, 60 days prior to registration;
• • Double-sided metallic hip prosthesis;
• • Inability or unwillingness to understand the information on trial-related topics, to give informed consent or to fill out QoL questionnaires.