High-Dose Radiotherapy for Prostate Cancer
(PROSINT Trial)
Trial Summary
What is the purpose of this trial?
The present study evaluates clinical outcomes and treatment-related toxicity following definitive ultra-high dose external beam radiotherapy delivered with two different regimens in patients with intermediate-risk adenocarcinoma of the prostate. Modern computer-driven technology enables the implementation of ultra-high hypofractionated Image-Guided Radiotherapy (IGRT) safely. Prostate cancer patients classified according to the current National Comprehensive Cancer Network (NCCN) guidelines as intermediate risk (biopsy Gleason score of 7 and/or Prostate Specific Antigen (PSA) level \>10 and ≤20 ng/mL and/or Stage T1, T2a, T2b or T2c) are eligible for this study. Patients will undergo IGRT with volumetric intensity-modulated arc radiotherapy (VMAT) with state-of-the-art treatment-planning and quality assurance procedures. Emphasis is placed on normal tissue sparing and delivery accuracy via the use of devices that ensure stability and beam location reproducibility. A rectal balloon with air filling will be used for prostate target immobilization and anatomical reproducibility, while a urethral catheter loaded with beacon transponders will be used to ensure set-up reproducibility and online target tracking. Previously untreated patients with intermediate-risk prostate cancer will be prospectively randomized to receive either 45 Gy in five fractions of 9 Gy each vs. 24 Gy in a single-dose. Patients will be followed at one month post-treatment and every 3 months for up to 12 months (+/- 4 weeks) and every 6 months thereafter. Acute and chronic toxicity evaluations will focus on urinary, rectal and sexual functions and will be assessed through validated questionnaires. Serum PSA values will be regularly acquired during follow-up. A multiparametric MRI will be performed at baseline, 6, 12 and 24 months following intervention. Additionally, a post-treatment diffusion-weighted MRI (DW-MRI) will be performed within 15 minutes of the first treatment, to measure early physiologic changes, such as perfusion and ischemia, that may correlate with clinically relevant end-points. Post-treatment prostate needle biopsies will be obtained at 24 months to evaluate pathologic response to therapy. The study will be continuously monitored for a minimum of 5 years. In the event unexpected severe (grade ≥3) toxicities are observed in any one of the treatment arms, the study will be terminated according to the stopping rule \>3/first 15 patients.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, alpha blockers are allowed if you have an International Prostate Symptom Score of 15 or less.
What data supports the effectiveness of the treatment IGRT 24 Gy single dose, IGRT 45 Gy in 5 fractions of 9 Gy for prostate cancer?
Research shows that using image-guided radiotherapy (IGRT) for prostate cancer can improve patient outcomes by allowing higher doses of radiation to be delivered more precisely, which may lead to better control of the cancer and fewer side effects. Studies have found that high-dose IGRT can improve survival rates and reduce the risk of cancer returning, while also minimizing damage to surrounding healthy tissues.12345
Is high-dose radiotherapy for prostate cancer safe?
Research shows that high-dose radiotherapy using image-guided techniques is generally safe for prostate cancer patients, with some studies indicating improved safety compared to older methods. However, as with any treatment, there can be side effects, so it's important to discuss these with your doctor.23467
How is the high-dose radiotherapy treatment for prostate cancer different from other treatments?
This treatment uses high-dose image-guided radiotherapy (IGRT), which allows for precise targeting of the prostate cancer with fewer sessions, potentially reducing side effects and improving patient quality of life compared to traditional methods. The use of IGRT helps in sparing normal tissues and allows for higher doses to be delivered safely, which may improve treatment outcomes.12345
Research Team
Madhur Garg, MD
Principal Investigator
Associate Clinical Director
Eligibility Criteria
Men over 50 with intermediate-risk prostate cancer, which means a Gleason score of 7, PSA levels between >10 and ≤20 ng/mL, and no evidence of spread beyond the prostate. They must have good performance status (able to carry out daily activities), a prostate size ≤100 grams, and an International Prostate Symptom Score ≤15.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either 45 Gy in 5 fractions of 9 Gy each over one week or 24 Gy in a single session
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at 1 month, every 3 months for 12 months, and every 6 months thereafter
Imaging and Biopsy Assessment
Multiparametric MRI performed at baseline, 6, 12, and 24 months; post-treatment DW-MRI within 15 minutes of first treatment; prostate needle biopsies at 24 months
Treatment Details
Interventions
- IGRT 24 Gy single dose
- IGRT 45 Gy in 5 fractions of 9 Gy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Albert Einstein College of Medicine
Lead Sponsor