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Prostate CancerPhase 1/2PHART6NCT01146340

Safety and Efficacy Study of Dose-escalated Hypofractionated Radiotherapy For Prostate Cancer

A Phase 1/2 study testing Hypofractionated radiotherapy in people with Prostate Cancer, run by Sunnybrook Health Sciences Centre at 1 site 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

The purpose of this study is to determine the safety and efficacy of a short course of radiotherapy (40 Gy / 5 fractions / 29 days) for the treatment of low- and intermediate-risk prostate cancer. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Hypofractionated radiotherapy
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
May 2010to Apr 2016
Phase
Phase 1/2
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 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men >18 years
  • Histologically confirmed prostate adenocarcinoma
  • Low or low-intermediate risk prostate cancer, defined as Clinical stage T1-2b, Gleason Score <=6, and PSA <15 ng/mL, OR Clinical stage T1-2b, Gleason Score 7, and PSA <=10 ng/mL

Who cannot join

  • Prior pelvic radiotherapy
  • Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
  • Diagnosis of bleeding diathesis
  • Presence of a hip prosthesis
  • Pelvic girth >40cm - Large prostate (>90cm3) on imaging
  • Severe lower urinary tract symptoms (International Prostate Symptom Score >19 or nocturia >3)

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

About this study

Official title: Phase I/II Study of Dose-Escalated Hypofractionated Radiotherapy for Low- and Intermediate-Risk Prostate Cancer

The purpose of this study is to determine the safety and efficacy of a short course of radiotherapy (40 Gy / 5 fractions / 29 days) for the treatment of low- and intermediate-risk prostate cancer.

Conditions
Prostate Cancer
Being tested
Hypofractionated radiotherapy
Keywords
Prostatic Neoplasms, Radiotherapy, Hypofractionation, Low and Intermediate Risk Prostate Cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • Hypofractionated radiotherapyRadiation

    40 Gy / 5 fractions / 29 days

Study groups in NCT01146340
Study groupRoleWhat they receive
SBRTExperimentalSBRT 40 Gy in 5 fractions over 29 days delivered using step and shoot IGRT
Receives: Radiation: Hypofractionated radiotherapy

What is being measured

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

  1. Incidence of grade 3+ rectal toxicity

    Common Terminology Criteria for Adverse Events (CTCAE) v3.0

    Measured: Acute period (<3 months)

Secondary outcomes (4)

  1. Incidence of grade 3+ urinary toxicity

    Common Terminology Criteria for Adverse Events (CTCAE) v3.0

    Measured: Acute (<3 months) and Late (>6 months)

  2. Quality of Life

    Expanded Prostate Cancer Index Composite (EPIC)

    Measured: 5 years

  3. Biochemical (ie. prostate specific antigen) disease free survival

    Measured: 5 year

  4. Incidence of grade 3+ rectal toxicity

    Common Terminology Criteria for Adverse Events (CTCAE) v3.0

    Measured: Late (>6 months)

Timeline

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

  1. First posted17 Jun 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionApr 2016
  4. Study completionApr 2016

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 1/2
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
NCT01146340
Sponsor's protocol ID
042-2010
Acronym
PHART6
Status last verified
Oct 2019
First submitted
14 Jun 2010
Last updated
4 Oct 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Quon HC, Musunuru HB, Cheung P, Pang G, Mamedov A, D'Alimonte L, Deabreu A, Zhang L, Loblaw A. Dose-Escalated Stereotactic Body Radiation Therapy for Prostate Cancer: Quality-of-Life Comparison of Two Prospective Trials. Front Oncol. 2016 Aug 29;6:185. doi: 10.3389/fonc.2016.00185. eCollection 2016.

    PubMed 27622157

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Hypofractionated radiotherapy in people with Prostate Cancer, 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 3 inclusion and 6 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 4 Oct 2019. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Incidence of grade 3+ rectal toxicity (time frame: Acute period (<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 NCT01146340, 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 4 Oct 2019.

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