Phase II Study of Single-Dose Image-Guided Radiotherapy (SDRT) for Prostate Cancer

Launched by FUNDACAO CHAMPALIMAUD · Jul 25, 2019

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to treat prostate cancer using a single, high dose of radiation therapy. The study focuses on men who have low or intermediate-risk prostate cancer, which means their cancer is relatively less aggressive. The treatment involves a special type of radiation called Single-Dose Image-Guided Radiotherapy (SD-IGRT), which uses advanced technology to give a precise dose of radiation while protecting nearby healthy tissues. Eligible participants are men aged 18 and older who have been diagnosed with prostate cancer and meet specific criteria, such as having a Gleason score of 7 or lower and a PSA level of 20 or below.

If you join this study, you will receive the treatment in a single session of 24 Gy, and your health will be monitored closely after that. You’ll have follow-up appointments at one month, then every three months for up to a year, and then every six months for several years to check for any side effects and to monitor your PSA levels. The trial aims to ensure the safety and effectiveness of this treatment while keeping track of any potential side effects related to urinary, rectal, and sexual health. This is a great opportunity to receive cutting-edge care while contributing to important research on prostate cancer treatment.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Signed study specific informed consent form;
• • Histologic confirmation of adenocarcinoma of the prostate by biopsy;
• • Up to 6 months of previous hormonal therapy is allowed (but not required)
• • PSA ≤ 20 prior to hormone therapy (if given);
• • Biopsy Gleason score ≤ 7
• • No direct evidence of regional or distant metastases after appropriate staging studies
• • Age ≥ 18
• • Performance Status 0-2
• • American Urological Association (AUA) score must be ≤ 20 (alpha blockers allowed)
• • Computerized Tomography (CT) or Ultrasound-based volume estimation of prostate gland ≤ 100 grams
• Exclusion Criteria:
• • Positive lymph nodes or metastatic disease from prostate cancer on imaging studies
• • Prior invasive malignancy unless disease free for a minimum of 3 years
• • MRI evidence of radiographic T3, T4 or N1 disease
• • Tumour Clinical stage T3 or T4 on MRI
• • PSA \> 20 ng/mL
• • Gleason score \> 7
• • Previous pelvic radiotherapy
• • Previous surgery for prostate cancer
• • Recent transurethral resection of the prostate (TURP) (less than 3 months)
• • Previous hormonal therapy given for more than 6 months prior to therapy
• • Previous significant urinary obstructive symptoms;
• • Significant psychiatric illness
• • Ultrasound or CT estimate of prostate volume \> 100 grams
• • Severe, active co-morbidity.