Evaluation of Tumor Control Based on Serial Multiparametric MRI and Post-Treatment Biopsies For Patients Treated With Dose Intensification to the Dominant Intra-Prostatic Lesion (DIL) Using Ultra-Hypofractionated, MR-Guided Radiotherapy

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT06542757
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 1.5 T Elekta Unity MR-Linac system — RADIATION
    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.
  • Hydrogel rectal spacer (SpaceOAR) — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Dec 9, 2024
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2029

Study Design

Enrollment
91 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: MRI-guided Intensity Modulated Radiotherapy
    All patients will undergo the injection of a hydrogel rectal spacer (SpaceOAR) 1 week before simulation. Patients will undergo ultra-hypofractionated radiation utilizing MR-guided, daily online adaptive planning. Patients will receive 9 Gy/fraction for five fractions for a total dose of 45 Gy to the prostate DIL while the rest of the prostate will be treated to a minimum dose to the rest of the prostate of 30 Gy in five fractions. Radiation will be given every other day, Monday through Friday, until 5 treatments have been completed. Patients will be followed at three and six months after treatment, and every six months thereafter through month 24 (+/- 4 weeks).

Primary Outcome Measure

Negative biopsy rate 24 months post-treatment [ Time Frame: 24 months post-treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

Find similar trials in New York, NY

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
NYU Langone Health· New York, NY

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