Clinical trial NCT05100472: A Study of Shorter Course Hormone Therapy and Radiation for High-risk Prostate Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Hypofractionated Pelvic Radiation
Brachytherapy Boost
NCCN High-Risk Prostate Cancer
Low-Intermediate Risk Decipher Genomic Score
Androgen Deprivation
21-405
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a phase II single arm trial.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Distant metastatic disease-free (DMF) rate
timeFrame: 3 years
Secondary outcomes:
measure: Pathological response rate
timeFrame: Between 24-36 months after radiation
measure: Cumulative incidence of biochemical failure
timeFrame: 3 years
measure: Overall survival rate
timeFrame: 3 years
measure: Acute and late physician-scored toxicity
timeFrame: 3 years
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Daniel Gorovets, MD
role: PRINCIPAL_INVESTIGATOR
References: