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

Phase II Trial of Short Course Androgen Deprivation, Hypofractionated Pelvic Radiation and a Brachytherapy Boost for NCCN High-Risk Prostate Cancer With Low-Intermediate Risk Decipher Genomic Score

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Biological: Androgen deprivation therapy (ADT); Radiation: Brachytherapy; Radiation: Hypofractionated pelvic External beam radiation

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Daniel Gorovets, MD; Phone Number: 212-639-3983; Email: gorovetd@mskcc.org
• Study Contact Backup: Name: Deaglan McHugh, MD; Phone Number: 631-212-6320

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Recruiting
      • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
      • Contact: Daniel Gorovets, MD; Phone Number: 212-639-3983
    • Middletown, New Jersey, United States, 07748
      • Recruiting
      • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
      • Contact: Daniel Gorovets, MD; Phone Number: 212-639-3983
    • Montvale, New Jersey, United States, 07645
      • Recruiting
      • Memorial Sloan Kettering Bergen (Limited Protocol Activities)
      • Contact: Daniel Gorovets, MD; Phone Number: 212-639-3983
  • New York
    • Commack, New York, United States, 11725
      • Recruiting
      • Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
      • Contact: Daniel Gorovets, MD; Phone Number: 212-639-3983
    • Harrison, New York, United States, 10604
      • Recruiting
      • Memorial Sloan Kettering Westchester (Limited Protocol Activities)
      • Contact: Daniel Gorovets, MD; Phone Number: 212-639-3983
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
      • Contact: Daniel Gorovets, MD; Phone Number: 212-639-3983
      • Contact: Deaglan McHugh, MD; Phone Number: 631-212-6320
    • Uniondale, New York, United States, 11553
      • Recruiting
      • Memorial Sloan Kettering Nassau (Limited Protocol Activities)
      • Contact: Daniel Gorovets, MD; Phone Number: 212-639-3983

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Hormone Therapy and Radiation; 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); 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.; Radiation: Brachytherapy; 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.; Radiation: Hypofractionated pelvic External beam 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distant metastatic disease-free (DMF) rate	Time to distant metastases will be estimated from the date of enrollment until distant metastases	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival rate		3 years
Pathological response rate		Between 24-36 months after radiation
Cumulative incidence of biochemical failure		3 years
Acute and late physician-scored toxicity	Using CTCAE v5.0. NCI Common Toxicity Criteria. The NCI scales are simple to complete and provide a means for assessing patient symptoms. Only the CTCAE v 5.0 will be used in toxicity grading.	3 years

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Daniel Gorovets, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2021
• Primary Completion (Estimated): October 19, 2024
• Study Completion (Estimated): October 19, 2024

Study Registration Dates

• First Submitted: October 19, 2021
• First Submitted That Met QC Criteria: October 19, 2021
• First Posted (Actual): October 29, 2021

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Hypofractionated Pelvic Radiation; Brachytherapy Boost; NCCN High-Risk Prostate Cancer; Low-Intermediate Risk Decipher Genomic Score; Androgen Deprivation; 21-405
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Androgens
• Other Study ID Numbers: 21-405

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No