Propranolol Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery

NCT03152786 | Terminated Phase 2 Results DMC FDA Drug

• 4 other identifiers: IRB00043227NCI-2017-00788CCCWFU 85716P30CA012197
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized pilot clinical trial studies how well propranolol hydrochloride works in treating patients with prostate cancer who are undergoing surgery. When stressed, the body makes a molecule that may prevent tumor cells from dying, and propranolol hydrochloride may affect the signals in cells that cause tumor cells survival and death.

Conditions

Prostate Carcinoma

Outcome Measures

Primary Outcomes (1)

• Mean Level of CREB Phosphorylation

  Determined using western blot in prostate tissue from men. CREB is a type of protein that binds to DNA in very specific places. CREB is related to long-term memory formation in the brain and is important in the formation of spatial memory. Phosphorylation alters the structural conformation of a protein, causing it to become activated, deactivated, or otherwise modifying its function. The level of CREB phosphorylation is an indicator of BAD activity.

  2 hours after taking or not taking propranolol prior to prostatectomy

Secondary Outcomes (6)

• BAD Phosphorylation

  2 hours after taking or not taking propranolol prior to prostatectomy

• Distress Score - National Comprehensive Cancer Network Distress Thermometer Questionnaire

  On the day of surgery before taking propranolol, prior to prostatectomy

• Levels of Transcripts That Reflect ADRB2/PKA Activation

  2 hours after taking or not taking propranolol prior to prostatectomy

• Plasma Catecholamine Levels (Including Epinephrine)

  2 hours after taking or not taking propranolol prior to prostatectomy

• Plasma Propranolol Levels

  2 hours after taking or not taking propranolol prior to prostatectomy

Study Arms (2)

Group I (propranolol hydrochloride)

EXPERIMENTAL

Patients receive propranolol hydrochloride PO 2 hours prior to standard of care prostatectomy.

Other: Laboratory Biomarker Analysis; Drug: Propranolol Hydrochloride; Other: Questionnaire Administration; Other: Survey Administration

Group II (no treatment)

ACTIVE COMPARATOR

Patients receive no treatment prior to standard of care prostatectomy.

Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration; Other: Survey Administration

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Group I (propranolol hydrochloride); Group II (no treatment)

Propranolol Hydrochloride DRUG

Given PO

Also known as: Inderal, Innopran XL

Group I (propranolol hydrochloride)

Questionnaire Administration OTHER

Ancillary studies

Group I (propranolol hydrochloride); Group II (no treatment)

Survey Administration OTHER

Ancillary studies

Group I (propranolol hydrochloride); Group II (no treatment)

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of prostate cancer undergoing prostatectomy
• Individuals able to understand and willing to sign an Institutional Review Board (IRB)-approved informed consent document

You may not qualify if:

• Men taking propranolol on a daily for any reason are excluded
• Men with baseline systolic blood pressure (SBP) \< 110 or heart rate (HR) \< 60
• Men unable to swallow pills
• History of current or past medical or psychiatric illness that would make participation difficult or not feasible at the discretion of the principal investigator or co-investigators

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Propranolol; propranolol CR

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)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Ashok Hemal, MD
• Organization: Wake Forest School of Medicine

ahemal@wakehealth.edu

336-716-5694

Study Officials

• Ashok Hemal

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: May 15, 2017
• Study Start: January 15, 2019
• Primary Completion: June 15, 2021
• Study Completion: February 28, 2023
• Last Updated: February 17, 2025
• Results First Posted: February 17, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)