Clinical trial NCT03507608: Assessing Induction of Double Strand Breaks With Androgen Receptor Partial Agonist in Patients on Androgen Suppression
Official title: Randomized Trial Assessing Induction of Double Strand Breaks With Androgen Receptor Partial Agonist in Patients on Androgen Suppression
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Prostate Cancer
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: Patrick C. Walsh Fund
First posted: 2018-04-25
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The initial phase is a 6-patient single-arm run-in phase to test feasibility and rule out futility of the intervention. All patients within the run-in phase will receive 50mg flutamide prior to brachytherapy and prostatic biopsy. If futility is ruled out (\>1 patients with DSBs on biopsy), then accrual will continue in the randomized in a 2:1 ratio (12:6 patients), for an all-trial total of 18 patients receiving flutamide vs 6 patients receiving placebo.
Primary purpose: TREATMENT

Brief summary: This is a prospective, single-center, two-phase study to assess the efficacy of single pulsed-dose flutamide in creating double strand breaks (DSBs) in prostate cancer within patients receiving central androgen suppression and brachytherapy.

Detailed description: This is a prospective, single-center, two-phase study to assess the efficacy of single pulsed-dose flutamide in creating DSBs (double strand breaks) in prostate cancer within patients receiving central androgen suppression and brachytherapy. The initial phase is a 6-patient single-arm run-in phase to test feasibility and rule out futility of the intervention. All patients within the run-in phase will receive 50mg flutamide prior to brachytherapy and prostatic biopsy. If futility is ruled out (\>1 patients with DSBs on biopsy), then accrual will continue in the randomized, double-blind phase. Subjects will be randomized in a 2:1 ratio (12:6 patients), for an all-trial total of 18 patients receiving flutamide vs 6 patients receiving placebo.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed prostate cancer
* At least one biopsy core with Gleason 7 or higher disease
* The patient has decided to undergo brachytherapy plus androgen suppression as treatment modality for his prostate cancer (with or without supplemental external beam radiation)
* Suitable volume of disease for biopsy:
* clinically palpable disease corresponding to (ipsilateral to) any involved core on biopsy
* Signed study-specific consent form prior to registration

Exclusion Criteria:

* Known hypersensitivity or allergic response to flutamide
* Severe hepatic impairment
* Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow up.

Primary outcomes:
measure: DNA double strand break formations
timeFrame: Post Flutimide exposure up to 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: SKCCC at Johns Hopkins
state: Maryland
Study officials:
affiliation: SKCCC at Johns Hopkins
name: Daniel Song, M.D.
role: PRINCIPAL_INVESTIGATOR
References: