Prostate Cancer
Conditions
Keywords
intensity-modulated radiotherapy, MR-guided
Brief summary
The purpose of this study is to assess the impact of this MR-guided radiotherapy on tumor control of the dominant intraprostatic lesion among patients with intermediate risk prostate cancer. This study of Radiotherapy to the Prostate and Dominant Lesion Using Ultra-Hypofractionated, MR-adaptive Radiation Therapy aims to evaluate tumor control after definitive ultra-hypofractionated external beam radiation therapy (including a simultaneously delivered high-dose boost to a dominant lesion as detected on prostate magnetic resonance imaging (MRI)) in patients with intermediate-risk prostate cancer. This will incorporate the use of multiparametric MRI for target segmentation and the use of the MR-linac with adaptive radiation planning to treat the prostate gland, incorporating a dose boost to the dominant intraprostatic lesion (DIL) that is visible on T2-weighted and diffusion-weighted imaging and de-escalation of dose to the remainder of the prostate.
Interventions
RADIATION1.5 T Elekta Unity MR-Linac system
Patients will receive 9 Gy/fraction (45 Gy total) for five fractions to the DIL, while the remainder of the prostate will be treated to 30 Gy in 5 fractions.
DEVICEHydrogel rectal spacer (SpaceOAR)
A rectal spacer will be placed one week prior to simulation to achieve a separation of approximately 1 cm between the prostate and anterior rectal wall to further minimize rectal toxicity in these patients. The hydrogel will remain in the body for about 12 weeks.
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Intermediate-risk prostate cancer patients will be eligible for this study. Risk groups will be assigned as per National Comprehensive Cancer Network (NCCN) guidelines. Intermediate-risk patients will be defined as: * PSA 10-20 ng/ml or * Gleason score = 7 or * Clinical stage T2b/T2c (T2b: the tumor has spread to more than one-half of one side of the prostate, but not to both sides. T2c: the cancer has invaded both sides of the prostate) 2. Age \> 18 3. Karnofsky Performance Status (KPS) \> 80 4. Prostate size \< 90 cc 5. Presence of a T2-visible prostatic lesion with maximum dimension of ≥ 0.5 cm and no more than two additional disease foci with a documented Prostate Imaging Reporting and Data System (PIRADS) 4-5 lesion 6. MRI findings: Lesion may contact the capsular edge, possible extracapsular extension (ECE) permitted 7. International Prostate Symptom Score \< 18 8. Satisfy all MRI screening criteria and be willing to fill out the standard MRI screening form
Exclusion criteria
1. Gleason score \>7 2. PSA \>20 ng/mL 3. Prior or concurrent androgen deprivation therapy for prostate cancer 4. MRI findings: suspicious for/probable ECE 5. MRI findings: \>2 disease foci identifiable 6. Evidence of metastatic disease on bone scan or MRI/CT 7. MRI ineligibility due to: the presence of a cardiac pacemaker, defibrillator, or other implanted metallic or electronic device which is considered MR unsafe; severe claustrophobia; inability to lie flat for the duration of the study; etc. 8. Metallic implant or device in the pelvis that might distort the local magnetic field and compromise quality of mp-MRI 9. Lateral pelvic separation greater than 50 cm and/or anterior-posterior separation greater than 35 cm which are incompatible with MR for Calculating ATtenuation (MRCAT) reconstruction 10. Contra-indications to receiving gadolinium contrast 11. KPS \< 80 12. Pelvic or Prostate MRI or CT (MRI preferred) evidence of radiographic T3, T4, or N1 disease 13. Prior history of transurethral resection of the prostate 14. Prior history of urethral stricture 15. Prior history of pelvic irradiation 16. History of inflammatory bowel disease 17. Unable to give informed consent 18. Unable to complete quality of life questionnaires 19. Abnormal complete blood count, including any of the following: * Platelet count less than 75,000/ml * Hb level less than 10 gm/dl * White blood cell (WBC) less than 3.5/ml * Abnormal renal function tests (creatinine \> 1.5)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Negative biopsy rate 24 months post-treatment | 24 months post-treatment | Outcome measure will be assessed via repeat biopsy of the dominant lesion as seen on mp-MRI |
| Serious toxicity rate 24 months post-treatment | 24 months post-treatment | Outcome measure will be assessed using NCI CTCAE v5.0 for gastrointestinal and genitourinary toxicity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prostate Specific Antigen (PSA) relapse rate at 24 months post-treatment | 24 months post-treatment | — |
| Proportion of patients with radiation-induced response in the dominant prostatic lesion 6 months post treatment | 6 months post-treatment | Outcome measure will be assessed using multi-parametric MR imaging. |
| Proportion of patients with radiation-induced response in the dominant prostatic lesion 24 months post treatment | 24 months post-treatment | Outcome measure will be assessed using multi-parametric MR imaging. |
| Change in International Prostate Symptom Score (I-PSS) | Baseline, Month 3 | The I-PSS is based on the answers to seven questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). Score are classified as follows: 0 - 7 = mildly symptomatic; 8 - 19 = moderately symptomatic; 20 - 35 = severely symptomatic. |
| Change in International Index of Erectile Function (IIEF) score | Baseline, Month 3 | The IIEF consists of 11 items, grouped into five factors: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. Items are scored in a 1-5 Likert-type scale, with higher scores indicating better erectile function. Erectile dysfunction (ED) severity is classified into five categories: no ED (score 22-25), mild (17-21), mild to moderate (12-16), moderate (8-11), and severe (5-7). |
| Change in genomic classifier (GC) Decipher score | Baseline, 6 months post-treatment | Scores are derived from the expression of 22 genes. Decipher scores are a continuous variable reported on a scale of 0 to 1. These scores are then stratified to three risk-categories: low (\<0.45), intermediate (≥ 0.45 - \< 0.6) and high (≥ 0.6) |
| Change in GC Decipher score | Baseline, 24 months post-treatment | Scores are derived from the expression of 22 genes. Decipher scores are a continuous variable reported on a scale of 0 to 1. These scores are then stratified to three risk-categories: low (\<0.45), intermediate (≥ 0.45 - \< 0.6) and high (≥ 0.6) |
Countries
United States
Contacts
CONTACTMichael Zelefsky, M.D
PRINCIPAL_INVESTIGATORMichael Zelefsky, M.D
NYU Langone Health
Outcome results
None listed