Feasibility and Toxicity of Degarelix for Prostate Downsizing Prior to Permanent Seed Prostate Brachytherapy

NCT01446991 | Completed Phase 2

• 1 other identifier: H11-08172
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

This study will investigate the efficacy of Degarelix, a Luteinizing Hormone Releasing Hormone (LHRH) antagonist, to reduce prostate volume prior to permanent seed prostate brachytherapy. There are 2 eligible populations of men, all of whom will have selected brachytherapy as their treatment of choice for their prostate cancer. Either they have an enlarged prostate that requires size reduction to render brachytherapy technically feasible, or they require androgen ablation in conjunction with brachytherapy for optimal tumor control. The hypothesis is that Degarelix will provide \> 30% volume reduction by 3 months in \> 30% of men.

Conditions

Prostate Cancer

Keywords

prostate neoplasm; brachytherapy; androgen ablation; benign prostatic hypertrophy; prostate size reduction; localized prostate cancer with prostate volume > 40 cc

Outcome Measures

Primary Outcomes (1)

• prostate volume reduction

  determined by transrectal ultrasound with planimetry volume calculation

  3 months

Secondary Outcomes (1)

• testosterone recovery

  12 months

Study Arms (2)

Favorable prostate cancer with pubic arch interference

EXPERIMENTAL

Men in this arm have chosen brachytherapy for management of localized prostate cancer and do not require androgen ablation for oncologic reasons but have an enlarged prostate causing pubic arch interference and thus require prostate size reduction prior to brachytherapy. They will have 2-3 months of Degarelix with measurement of prostate volume at 8 and 12 weeks.

Drug: Degarelix

Intermediate risk prostate cancer, 6 months Degarelix

EXPERIMENTAL

Men in this arm have higher risk prostate cancer (upper tier intermediate risk by National Comprehensive Cancer Network \[NCCN\] guidelines) and require 6 months of androgen ablation in conjunction with brachytherapy. Prostate size must be \> 40 cc at baseline so that prostate size reduction measurements are appropriate. Prostate measurements by transrectal ultrasound with be taken at 12 weeks and 20 weeks.

Drug: Degarelix

Interventions

Degarelix DRUG

240 mg loading dose followed by monthly 80 mg maintenance dose for 2-3 months

Favorable prostate cancer with pubic arch interference

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologic diagnosis of prostate cancer
• Favorable risk disease (cT1 or T2a, Gleason score (GS) 6, and Prostate Specific Antigen (PSA) \< 10 ng/mL)
• Low-tier intermediate risk disease (cT2c,GS=6,and PSA 10-15 ng/mL, OR GS=7 and PSA \< 10 ng/mL)
• Intermediate risk disease AND androgen deprivation therapy recommended by the treating physician for oncologic reasons such as (≥ 50% positive biopsy cores,cT2c,PSA 15-20 ng/mL,GS=7)
• Patient requires baseline planning trans-rectal ultrasound for the purposes of prostate brachytherapy, showing prostate volume \> 40 mL and pubic arch interference (not required for those requiring androgen ablation for oncologic reasons)

You may not qualify if:

• castrate serum testosterone level
• previous or concurrent pelvic radiotherapy
• unable to give written informed consent
• contraindications to permanent seed prostate brachytherapy or to androgen deprivation therapy
• prior treatment for prostate cancer
• prior trans-urethral resection of the prostate
• previous therapy with a 5-α reductase inhibitor, anti-androgen agent, or LHRH agonist
• previous therapy with degarelix

Sponsors & Collaborators

• British Columbia Cancer Agency: lead

Study Sites (3)

Abbottsford Cancer Center

Abbottsford, British Columbia, Canada

Location

Fraser Valley Cancer Center

Surrey, British Columbia, Canada

Location

Vancouver Cancer Center

Vancouver, British Columbia, V5Z4E6, Canada

Location

Related Publications (1)

• Korzeniowski MA, Crook JM, Bowes D, Gaztanaga M, Ots A, Jazwal J, Rose J, Tetreault-Laflamme A, Pilote L, Halperin R, Kim D, Petrik D, Araujo C, Bachand F. A Phase II trial of 8 weeks of degarelix for prostate volume reduction: Efficacy and hormonal recovery. Brachytherapy. 2018 May-Jun;17(3):530-536. doi: 10.1016/j.brachy.2017.12.005. Epub 2018 Feb 2.

  PMID: 29398594 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Prostatic Hyperplasia

Interventions

acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide

Condition Hierarchy (Ancestors)

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

Study Officials

• Juanita M Crook, MD

  British Columbia Cancer Agency

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD FRCPC Radiation Oncology

Study Record Dates

• First Submitted: October 4, 2011
• First Posted: October 5, 2011
• Study Start: April 1, 2012
• Primary Completion: February 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 27, 2020

Record last verified: 2020-01

Locations

CA (3)