A Study of Shorter Course Hormone Therapy and Radiation for High-risk Prostate Cancer

NCT05100472 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: 21-405
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to find out whether combining a shorter than standard course of ADT with standard prostate brachytherapy and hypofractionated external beam radiation therapy is a safe and effective way to prevent high-risk prostate cancer from coming back and/or spreading to other parts of the body.

Conditions

Prostate Cancer

Keywords

Hypofractionated Pelvic Radiation; Brachytherapy Boost; NCCN High-Risk Prostate Cancer; Low-Intermediate Risk Decipher Genomic Score; Androgen Deprivation; 21-405

Outcome Measures

Primary Outcomes (1)

• Distant metastatic disease-free (DMF) rate

  Time to distant metastases will be estimated from the date of enrollment until distant metastases

  3 years

Secondary Outcomes (4)

• Pathological response rate

  Between 24-36 months after radiation

• Cumulative incidence of biochemical failure

  3 years

• Overall survival rate

  3 years

• Acute and late physician-scored toxicity

  3 years

Study Arms (1)

Hormone Therapy and Radiation

EXPERIMENTAL

Patients enrolled in this study will receive ADT for 6 months which will consist of bicalutamide 50 mg PO daily starting approximately 1-2 weeks before leuprolide 22.5mg injected every 3 months. The HDR prostate brachytherapy procedure will be performed approximately 3 months after starting ADT to allow for potential radiosensitization and cytoreduction. Approximately 4 weeks after the HDR boost, patients will receive image-guided, intensity-modulated, hypofractionated radiation therapy targeting the prostate, seminal vesicles and pelvic lymph nodes to a dose of 25 Gy in 5 fractions delivered daily.

Biological: Androgen deprivation therapy (ADT); Radiation: Brachytherapy; Radiation: Hypofractionated pelvic External beam radiation

Interventions

Androgen deprivation therapy (ADT) BIOLOGICAL

ADT will include bicalutamide 50 mg PO daily started 1-2 weeks before leuprolide 22.5mg IM or SQ delivered every 3 months x 2. Bicalutamide will be continued through radiation and then discontinued on the day of the last fraction. Leuprolide can be given at different doses, but must be given for a total planned duration of 6 months.

Hormone Therapy and Radiation

Brachytherapy RADIATION

After approximately 3 months (+/- 1 month) of neoadjuvant ADT, patients will undergo general anesthesia for outpatient transperineal high dose rate (HDR) interstitial prostate brachytherapy implant.

Hormone Therapy and Radiation

Hypofractionated pelvic External beam radiation RADIATION

Patients will receive image-guided, intensity-modulated, hypofractionated radiation therapy targeting the prostate, seminal vesicles and pelvic lymph nodes to a dose of 25 Gy in 5 fractions delivered daily.

Hormone Therapy and Radiation

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically-proven diagnosis of prostate adenocarcinoma
• Clinical stage T3-4 or Gleason score 8-10 or PSA \>20 ng/ml
• °If radiographic T3-T4 is the only high-risk factor, it must be "consistent with" or \>90% probability of having T3-T4 disease determined by the reading radiologist.
• Decipher genomic score ≤0.6
• Willing and able to provide written informed consent and Authorization for Use and Release of Health and Research Study Information (HIPAA authorization)
• Age ≥18
• KPS ≥70 or ECOG 0-2
• Estimated life expectancy \>5 years
• Baseline prostate volume ≤90 cc
• Baseline IPSS ≤20
• No contraindications to ADT, brachytherapy, or pelvic external beam radiation therapy as determined by the treating radiation oncologist per standard practice
• Patients who have already started ADT consisting of bicalutamide 50 mg PO daily with leuprolide or an equivalent GnRH analogue are eligible if given for ≤ 60 days prior to registration

You may not qualify if:

• Regional lymph node or metastatic disease
• Prior pelvic radiation
• Prior prostate surgery (including TURP or cryosurgery)
• Prior history of inflammatory bowel disease
• Unable to undergo anesthesia or brachytherapy
• Active second malignancy or past history of malignancies diagnosed within the last 2 years that requires active therapy and/or in remission, with the exception of resected non-melanoma skin cancers, non-muscle invasive bladder cancer, stage I head and neck cancer, or stage I colorectal cancer

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Androgen Antagonists; Brachytherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Radiotherapy; Therapeutics

Study Officials

• Daniel Gorovets, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a phase II single arm trial.

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: October 29, 2021
• Study Start: October 19, 2021
• Primary Completion (Estimated): October 19, 2026
• Study Completion (Estimated): October 19, 2026
• Last Updated: November 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

US (7)