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Prostate Cancer RecurrentNCT02560181

Pilot Study of Whole Gland Salvage HDR Prostate Brachytherapy for Locally Recurrent Prostate Cancer

A study testing HDR brachytherapy in people with Prostate Cancer Recurrent, run by Sunnybrook Health Sciences Centre at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Radiation therapy is considered a standard treatment option for the management of localized prostate cancer. Among the 20-30% of patients who recur, there is no consensus on the optimal salvage therapy. Read more about this study

Who is it for?
Any age, men only
Conditions the study is for
Prostate Cancer Recurrent
What is being tested?
HDR brachytherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteCanada
Study dates
Aug 2014to 30 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 Any age
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Biopsy confirmed locally recurrent prostate adenocarcinoma > 30mths after completion of XRT by stereotactic transperineal biopsy
  • Staging T2-weighted, DWI- and DCE- MRI that demonstrates recurrence confined to prostate, and correlates with stereotactic transperineal biopsy
  • Previous external beam radiotherapy for prostate cancer with standard/conventional fractionation (1.8-2.0 Gy per fraction), or moderate hypofractionation (2.4-3.4 Gy per fraction).
  • Staging CT or MRI (abdomen and pelvis) and bone scan are negative for metastases
  • IPSS < 15
  • Baseline (post XRT) serum PSA < 10ng/mL
  • Prostate volume as measured by TRUS < 50cc
  • ECOG performance status 0-1

Who cannot join

  • Disease adjacent to the urethra as visible on MRI
  • Any of the following prior therapies; TURP, radionuclide prostate brachytherapy, prostatectomy or prostatic cryosurgery, HIFU, bilateral orchiectomy, chemotherapy for prostatic carcinoma
  • Evidence of castrate resistance (defined as PSA > 3ng/mL while testosterone is < 1.7nmol/L) Patients could have been on combined androgen blockade with initial XRT but are excluded if this was started due to PSA progression

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Odette Cancer Centre, Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N3M5

Other trials in Canada

About this study

Radiation therapy is considered a standard treatment option for the management of localized prostate cancer. Among the 20-30% of patients who recur, there is no consensus on the optimal salvage therapy. Salvage options available for isolated local recurrence include; temporary or permanent implantation of radioactive seeds into the prostate, complete removal of the prostate gland, use of low temperatures to treat the disease (cryotherapy), and high frequency ultrasound to treat the disease. There are risks of complications associated with all these treatments, and there is presently no consensus as to which treatment is the best. The aim of this pilot study is to look at the feasibility and toxicities of whole gland salvage treatment of the prostate using temporary implantation of radioactive seeds into the prostate.

Read the detailed description

Radiation therapy is considered a standard treatment option for the management of localized prostate cancer. Among the 20-30% of patients who recur, there is no consensus on the optimal salvage therapy. Salvage options available for isolated local recurrence include; temporary or permanent implantation of radioactive seeds into the prostate, complete removal of the prostate gland, use of low temperatures to treat the disease (cryotherapy), and high frequency ultrasound to treat the disease. There are risks of complications associated with all these treatments, and there is presently no consensus as to which treatment is the best. The aim of this pilot study is to look at the feasibility and toxicities of whole gland salvage treatment of the prostate using temporary implantation of radioactive seeds into the prostate. Reports of the efficacy and toxicities of whole gland salvage HDR brachytherapy for local recurrence after external beam radiation therapy are limited to single-institution studies with small sample sizes. Given that our institution has the highest volume of prostate brachytherapy cases in Ontario and that we receive a significant number of referrals from other cancer centres for brachytherapy, this study will aim to add to the literature and help guide salvage therapy practice within our institution.

Being tested
HDR brachytherapy
Keywords
recurrent prostate cancer, HDR whole gland salvage
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • HDR brachytherapyRadiation

    Whole gland salvage

Study groups in NCT02560181
Study groupRoleWhat they receive
HDR whole gland salvage treatmentOtherLocally recurrent prostate cancer Whole gland HDR brachytherapy administered Whole gland dose=10.5Gy x 2 fractions delivered one week apart GTV dose=13.5Gy x 2 fractions delivered one week apart
Receives: Radiation: HDR brachytherapy

What is being measured

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

  1. Acute GI toxicities

    Acute GI toxicities using NCI CTCAE v4.0

    Measured: 3 mths post brachytherapy

  2. Acute GU toxicities

    Acute GU toxicities utilizing NCI CTCAE v4.0

    Measured: 3 moths post brachytherapy

Secondary outcomes (6)

  1. Acute GU symptoms

    Acute GU symptoms American Urological Association Symptom Index Score (IPSS)

    Measured: 5 years

  2. Late GU symptoms

    Late GU symptoms American Urological Association Symptom Index Score (IPSS)

    Measured: 5 years

  3. Late GI toxicities

    Late GI toxicities using NCI CTCAE v.4.0

    Measured: 5 years

  4. Late GU toxicities

    Late GU Toxicities using NCI CTCAE v.4.0

    Measured: 5 years

  5. Biochemical disease free survival

    PSA

    Measured: 5 years

  6. Quality of Life (QoL)

    QoL measured using Expanded Prostate Cancer Index Composite (EPIC)

    Measured: 5 years

Timeline

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

  1. First posted25 Sep 2015 (estimated)
  2. Study startAug 2014
  3. Primary completion30 Aug 2027 (estimated)
  4. Study completion30 Aug 2027 (estimated)

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02560181
Sponsor's protocol ID
clinicaltrials_hchu_180-2014
Status last verified
Nov 2024
First submitted
17 Sep 2015
Last updated
27 Nov 2024
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing HDR brachytherapy in people with Prostate Cancer Recurrent, run by Sunnybrook Health Sciences Centre at 1 site 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 8 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Acute GI toxicities (time frame: 3 mths post brachytherapy). The study lists 2 primary outcomes in all. 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 NCT02560181.

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 Nov 2024.

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