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NCT Number: NCT06542757

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • History of inflammatory bowel disease
  • Unable to give informed consent
  • Unable to complete quality of life questionnaires
  • 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)

Treatment and study plan

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.

Primary outcomes

  1. Negative biopsy rate 24 months post-treatment

    Time frame: 24 months post-treatment

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

  2. Serious toxicity rate 24 months post-treatment

    Time frame: 24 months post-treatment

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

Secondary outcomes

  1. Prostate Specific Antigen (PSA) relapse rate at 24 months post-treatment

    Time frame: 24 months post-treatment

  2. Proportion of patients with radiation-induced response in the dominant prostatic lesion 6 months post treatment

    Time frame: 6 months post-treatment

    Outcome measure will be assessed using multi-parametric MR imaging.

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

    Time frame: 24 months post-treatment

    Outcome measure will be assessed using multi-parametric MR imaging.

  4. Change in International Prostate Symptom Score (I-PSS)

    Time frame: 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.

  5. Change in International Prostate Symptom Score (I-PSS)

    Time frame: Baseline, Month 6

    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.

  6. Change in International Prostate Symptom Score (I-PSS)

    Time frame: Baseline, Month 12-18

    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.

  7. Change in International Index of Erectile Function (IIEF) score

    Time frame: 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).

  8. Change in International Index of Erectile Function (IIEF) score

    Time frame: Baseline, Month 6

    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. 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).

  9. Change in International Index of Erectile Function (IIEF) score

    Time frame: Baseline, Month 12-18

    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. 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).

  10. Change in genomic classifier (GC) Decipher score

    Time frame: 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)

  11. Change in GC Decipher score

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Zelefsky, M.D

CONTACT

[email protected]

212-263-4432

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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 (TUMORNATOR I)

Important dates

Study start
2024
Primary completion
2027
Study completion
2029
First posted
Aug 7, 2024
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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