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Hypofractionated IGRT at a prescription dose of 45 Gy in 5 fractions of 9 Gy delivered in five consecutive days

single fraction IGRT at a prescription dose of 24 Gy

Administration of 9 Gy in five consecutive days, to a total dose of 45 Gy radiation

IGRT 45 Gy in 5 fractions of 9 Gy

Administration of a single dose of 24 Gy in one session

IGRT 24 Gy single dose

0.4 mg by mouth daily starting the day of simulation and until 2 weeks post-treatment.

Madhur Garg, MD

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.

This is open label feasibility study where patients enrolled in the study will undergo image-guided, intensity-modulated radiotherapy using the same equipment, techniques, and treatment-planning procedures as currently practiced at CCU. Eligible patients will receive either 45 Gy in 5 sessions each of 9 Gy delivered in one week (arm A) or 24 Gy in 1 session (arm B) to assess the dose limiting toxicities in the two groups. Patients will be randomized to arm A or arm B.

Dose limiting toxicity (DLT) is defined as any Grade 3 urinary or rectal toxicity, based on NCI CTCAE v4.0, observed within 3 months of completion of protocol radiation. If, at any point in the conduct of the trial, DLTs are observed in three patients in a study arm, accrual to that arm will be terminated.

There are three aspects of this study that will be different from the currently used standard treatment for definitive external beam treatment of prostate cancer:

1. The dose-fractionation scheme, as per the treatment arm.
2. Acquisition of a set of prostate biopsies at 24 months post treatment
3. Examination of imaging response based on multi-parametric MRI

A Pilot Study of Ultra-High-Dose Hypofractionated or Single-Dose Radiotherapy for Intermediate Risk Prostate Cancer

Comparison of treatment related adverse events as measured by Common Toxicity Criteria for Adverse Effects v4.0 over a 5 year time frame

The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms.The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.

Albert Einstein College of Medicine

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Patients will be treated using volumetric intensity-modulated arc radiotherapy (IGRT-VMAT) with emphasis on normal tissue sparing and delivery accuracy via the use of devices that ensure stability and beam location reproducibility. Patients will be treated with 45 Gy in five fractions of 9 Gy over 5 consecutive days.

Previously untreated patients with prostate cancer will be treated with 45 Gy in five fractions of 9 Gy over 5 consecutive days.

Patients enrolled in the study will undergo IGRT-VMAT with state-of-the-art treatment-planning and quality assurance procedures with emphasis on normal tissue sparing and delivery accuracy via the use of devices that ensure stability and beam location reproducibility.

Image-guided, volumetric intensity-modulated arc radiotherapy (IGRT-VMAT)

A rectal balloon with air filling will be used for prostate target immobilization and anatomical reproducibility.

Rectal balloon with air filling

A urethral catheter loaded with beacon transponders will be used to ensure set-up reproducibility and online target tracking.

Urethral catheter loaded with beacon transponders

Carlo Greco, MD

The present study evaluates the clinical outcomes following definitive ultra-high dose per fraction external beam radiation therapy delivered in patients with organ-confined adenocarcinoma of the prostate.

Patients enrolled in the study will undergo image-guided, volumetric intensity-modulated arc radiotherapy (IGRT-VMAT) with state-of-the-art treatment-planning and quality assurance procedures with emphasis 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 prostate cancer will be treated with 45 Gy in five fractions of 9 Gy over 5 consecutive days.

Patients will be followed at one month post-treatment and every 3 months for up to 12 months (+/- 4 weeks) and every 6 months (+/- 6 weeks) thereafter. Acute and late toxicity evaluations will focus, though not exclusively, on urinary, rectal and sexual functions and will be assessed through validated Expanded Prostate Cancer Index Composite (EPIC), International prostate symptom score (IPSS) and International index of erectile function (IIEF) questionnaires. Serum Prostate Specific Antigen (PSA) values will be drawn on the same schedule as clinical follow-up. Patients will be continuously monitored for a minimum of 5 years.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Pilot Study of Ultra-High-Dose Hypofractionated or Single-Dose Radiotherapy for Intermediate Risk Prostate Cancer	NCT04147806	Prostate Cancer	IGRT 45 Gy in 5... IGRT 24 Gy sing... Dexamethasone Tamsulosin	50 Years -	Albert Einstein College of Medicine
A Pilot Study of Ultra-High-Dose Hypofractionated or Single-Dose Radiotherapy for Intermediate Risk Prostate Cancer	NCT04147806	Prostate Cancer	IGRT 45 Gy in 5... IGRT 24 Gy sing... Dexamethasone Tamsulosin	50 Years -	Albert Einstein College of Medicine
Hypofractionated Image-Guided Radiotherapy (IGRT) With Organ Motion Mitigation and Urethral Sparing for Prostate Cancer	NCT02761889	Adenocarcinoma ...	IGRT 45 Gy in 5... Image-guided, v... Rectal balloon ... Urethral cathet...	40 Years -	Fundacao Champalimaud
Hypofractionated Image-Guided Radiotherapy (IGRT) With Organ Motion Mitigation and Urethral Sparing for Prostate Cancer	NCT02761889	Adenocarcinoma ...	IGRT 45 Gy in 5... Image-guided, v... Rectal balloon ... Urethral cathet...	40 Years -	Fundacao Champalimaud

Spots Global Cancer Trial Database for igrt 45 gy in 5 fractions of 9 gy