A Study of Stereotactic Body Radiation Therapy (SBRT) Without Androgen Deprivation Therapy (ADT) in People With Unfavorable Intermediate-Risk Prostate Cancer

Conditions

• Prostate Cancer

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Stereotactic Body Radiation Therapy (SBRT) — RADIATION
  Patients with a low or intermediate risk Decipher score will receive radiation targeting the seminal prostate and seminal vesicles to a dose of 40 Gy in 5 fractions delivered every other day.
• Stereotactic Body Radiation Therapy (SBRT) — RADIATION
  Patients with high risk Decipher scores will receive radiation targeting the prostate and seminal vesicles to a dose of 40 Gy in 5 fractions with a simultaneous integrated boost to 45 Gy of any dominant intraprostatic lesion as well as radiation to the pelvic lymph nodes to a dose of 25 Gy in 5 fractions delivered every other day.

Study Details

The researchers are doing this study to find out if stereotactic body radiation therapy (SBRT) without androgen deprivation therapy (ADT) is an effective treatment approach for people with unfavorable intermediate-risk prostate. The researchers will see whether SBRT can prevent participants' cancer from coming back and/or spreading to other parts of the body. In addition, they will look closely at how safe and effective it is to rely on Decipher test results for determining which patients would benefit from more extensive radiation treatments

Key Dates

Start date

Dec 9, 2021

Status verified

May 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

215 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Patients with low-intermediate risk Decipher scores
  Will receive ultrahypofractionated EBRT to the prostate and seminal vesicles (40Gy in 5 fractions).
• Experimental: Patients with high risk Decipher scores
  Will receive ultrahypofractionated EBRT to the prostate and seminal vesicles (40Gy in 5 fractions) with a boost of up to 45Gy to the dominant intraprostatic lesion as identified on pretreatment MRI plus hypofractionated pelvic EBRT (25Gy in 5 fractions).

Primary Outcome Measure

Rate of biochemical progression free survival [ Time Frame: 2 years ]

Central Contacts

• Daniel Gorovets, MD
  212-639-3983
  [email protected]
• Marisa Kollmeier, MD
  212-639-3952

Locations (7)

Find similar trials in Basking Ridge, NJ

Related Studies

• [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate Cancer
  Recruiting · Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey
• Integrated Cancer Repository for Cancer Research
  Recruiting · University of Nebraska · Greenwood Village, Colorado
• Helping Men Adhere to Sexual Rehabilitation Following Prostate Cancer Surgery
  Recruiting · Memorial Sloan Kettering Cancer Center · New York, New York
• A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
  PHASE2 · Recruiting · Astellas Pharma Global Development, Inc. · Anchorage, Alaska