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

NCT06542757 | Recruiting DMC FDA Device

• 1 other identifier: 23-01590
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

intensity-modulated radiotherapy; MR-guided

Outcome Measures

Primary Outcomes (2)

• Negative biopsy rate 24 months post-treatment

  Outcome measure will be assessed via repeat biopsy of the dominant lesion as seen on mp-MRI

  24 months post-treatment

• Serious toxicity rate 24 months post-treatment

  Outcome measure will be assessed using NCI CTCAE v5.0 for gastrointestinal and genitourinary toxicity.

  24 months post-treatment

Secondary Outcomes (11)

• 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

• Proportion of patients with radiation-induced response in the dominant prostatic lesion 24 months post treatment

  24 months post-treatment

• Change in International Prostate Symptom Score (I-PSS)

  Baseline, Month 3

• Change in International Prostate Symptom Score (I-PSS)

  Baseline, Month 6

Study Arms (1)

MRI-guided Intensity Modulated Radiotherapy

EXPERIMENTAL

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).

Radiation: 1.5 T Elekta Unity MR-Linac system; Device: Hydrogel rectal spacer (SpaceOAR)

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.

MRI-guided Intensity Modulated Radiotherapy

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.

MRI-guided Intensity Modulated Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Age \> 18
• Karnofsky Performance Status (KPS) \> 80
• Prostate size \< 90 cc
• 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
• MRI findings: Lesion may contact the capsular edge, possible extracapsular extension (ECE) permitted
• International Prostate Symptom Score \< 18
• Satisfy all MRI screening criteria and be willing to fill out the standard MRI screening form

You may not qualify if:

• Gleason score \>7
• PSA \>20 ng/mL
• Prior or concurrent androgen deprivation therapy for prostate cancer
• MRI findings: suspicious for/probable ECE
• MRI findings: \>2 disease foci identifiable
• Evidence of metastatic disease on bone scan or MRI/CT
• 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.
• Metallic implant or device in the pelvis that might distort the local magnetic field and compromise quality of mp-MRI
• 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
• Contra-indications to receiving gadolinium contrast
• KPS \< 80
• Pelvic or Prostate MRI or CT (MRI preferred) evidence of radiographic T3, T4, or N1 disease
• Prior history of transurethral resection of the prostate
• Prior history of urethral stricture
• Prior history of pelvic irradiation

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Michael Zelefsky, M.D

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Zelefsky, M.D

CONTACT

212-263-4432; CancerTrials@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 7, 2024
• Study Start: December 9, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2029
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal will be provided access to achieve aims in the approved proposal. Requests should be directed to Michael.Zelefsky@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)