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Prostate CancerPhase 2NCT01446991

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

A Phase 2 study testing Degarelix in people with Prostate Cancer, run by British Columbia Cancer Agency at 3 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 80 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Degarelix
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
3 sitesCanada
Study dates
Apr 2012to Dec 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • Abbottsford Cancer Center

    Abbottsford, British Columbia

  • Fraser Valley Cancer Center

    Surrey, British Columbia

  • Vancouver Cancer Center

    Vancouver, British Columbia, V5Z4E6

Other trials in Canada

About this study

Official title: Phase II Trial Assessing the Feasibility and Toxicity of Degarelix in Achieving Prostate Downsizing Prior to Treatment With Permanent Seed Prostate Brachytherapy

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.

Read the detailed description

All men will have a baseline transrectal ultrasound for brachytherapy planning that has demonstrated an enlarged prostate with or without pubic arch obstruction. After signing the informed consent document they will have a loading dose of 240 mg Degarelix and then monthly maintenance dose injections of 80 mg until such time as sufficient prostate reduction has occured (2-3 months) or they complete the 6 months of required androgen ablation for their disease status.

Conditions
Prostate Cancer
Being tested
Degarelix
Keywords
prostate neoplasm, brachytherapy, androgen ablation, benign prostatic hypertrophy, prostate size reduction, localized prostate cancer with prostate volume > 40 cc
Medical subject headings
Prostatic Neoplasms, Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DegarelixDrug

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

  • DegarelixDrug

    240 mg loading dose of Degarelix followed by 80 mg maintenance doses every month for a total duration of 6 months.

Study groups in NCT01446991
Study groupRoleWhat they receive
Favorable prostate cancer with pubic arch interferenceExperimentalMen 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.
Receives: Drug: Degarelix
Intermediate risk prostate cancer, 6 months DegarelixExperimentalMen 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.
Receives: Drug: Degarelix

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. prostate volume reduction

    determined by transrectal ultrasound with planimetry volume calculation

    Measured: 3 months

Secondary outcomes (1)

  1. testosterone recovery

    Luteinizing Hormone(LH), Follicle Stimulating Hormone (FSH) and testosterone will be measured at 1, 3, 6, 9 and 12 months following cessation of Degarelix.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2011 (estimated)
  2. Study startApr 2012
  3. Primary completionFeb 2017
  4. Study completionDec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01446991
Sponsor's protocol ID
H11-08172
Status last verified
Jan 2020
First submitted
4 Oct 2011
Last updated
27 Jan 2020
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 29398594

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Degarelix in people with Prostate Cancer, run by British Columbia Cancer Agency at 3 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

prostate volume reduction (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01446991, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.

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