Hypofractionated Accelerated Radiotherapy for Low Risk Localized Prostate Cancer

Prostate Cancer Clinical Trial

— pHART3  

Official title:

Hypofractionated Accelerated Radiotherapy for Low Risk Localized Prostate Cancer (pHART 3)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01578902
• Other study ID #: 371-2006
• Status: Completed
• Phase: N/A
• Start date: October 2006
• Est. completion date: April 2013

Study information

• Verified date: November 2020
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety and efficacy of a short course of radiotherapy (35 Gy / 5 fractions / 29 days) for the treatment of low-risk prostate cancer.

Description:

Rationale for Proposed Study With the availability of intensity modulated radiotherapy (IMRT) at the Odette Cancer Centre (OCC), there is an opportunity to explore the use of a much more intensive hypofractionation schedule for prostate cancer. Using an alpha/beta ratio of 1.3, a dose of 35 Gy in 5 fractions would be equivalent to 88 Gy delivered in 2 Gy fractions. For normal tissues (alpha/beta value of 2), this would be equivalent to 78 Gy in 2 Gy fractions. As such, the linear quadratic equation predicts that 35 Gy in 5 fractions should not result in any increased late toxicity for normal tissues compared to standard dose escalated radiotherapy. However, the biological dose to the prostate cancer would be significantly increased. As a safety precaution for this study proposal, the investigators propose to deliver 35 Gy in 5 fractions over 5 weeks (one radiotherapy fraction of 7 Gy per week) to allow for normal tissue repair.

With IMRT, it is expected that there will be superior conformality of the high dose region around the target volume. As well, the use of daily on-line imaging will allow us to eliminate interfraction prostate motion errors and use tighter planning target volume margins for any residual intrafraction motion. At OCC, such an approach has already been shown to be feasible and is currently employed in the phase 1/2 concomitant boost study for high risk prostate cancer.

If proven to be safe and effective, such a hypofractionated radiotherapy schedule may have significant practical advantages as well. With only 1 fraction of radiotherapy delivered each week (for a total of 5 weeks), there are huge savings in resource utilization and increased convenience for patients.

The investigators propose to start a small phase 1 study to explore the use of this dose fractionation for men with low risk prostate cancer. The primary endpoint for this small pilot study would be acute and late normal tissue toxicities. If proven to be feasible and safe, external peer-reviewed funding will be sought to further explore this novel treatment schedule in a larger phase 2 setting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: April 2013
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Informed consent signed (Appendix A)

• Adult men greater than 18 years of age

• Histologically confirmed diagnosis of adenocarcinoma of the prostate (centrally reviewed).

• Clinical stage T1-T2b, Gleason Score < 6, and PSA < 10 ng/mL

• Less than 50% of biopsy cores +ve for cancer

• Less than 50% overall surface area involved with cancer

• Neoadjuvant hormone suppression therapy is allowed. However, PSA, must have been performed within 2 months of starting androgen suppression therapy. If androgen suppression therapy has been started LHRH agonist must be continued for a minimum of 3 months before initiation of gold fiducial marker insertion & radiotherapy planning.

Exclusion Criteria:

• Prior pelvic radiotherapy.

• Concurrent anticoagulation medication (if it is unsafe to discontinue for gold seed insertion)

• Diagnosis of bleeding diathesis

• Presence of a hip prosthesis

• Pelvic girth >40cm (to ensure visibility of gold seeds on electronic portal imaging device)

• Large prostate (> 60 cm3) on imaging

• Severe lower urinary tract symptoms (International Prostate Symptom Score > 15 or nocturia > 3)

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Stereotactic ablative body radiotherapy
35Gy/5 fractions/29 days

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Canadian Association of Radiation Oncology

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Grade 3+ Gastrointestinal Toxicity	Common Terminology Criteria for Adverse Events (CTCAE) v3.0	Acute period (up to 6 months)
Secondary	Incidence of Grade 3+ Genitourinary Toxicity	Common Terminology Criteria for Adverse Events (CTCAE) v3.0	Acute (up to 6 months) and Late (6 months and after)
Secondary	Incidence of Grade 3+ Rectal and Urinary Toxicity	Common Terminology Criteria for Adverse Events (CTCAE) v3.0	Late (6 months and after)
Secondary	Patient Reported Quality of Life	Expanded Prostate Cancer Index Composite (EPIC)	up to 5 years
Secondary	Biochemical (ie. Prostate Specific Antigen) Disease Free Survival	Failure = Follow-up PSA greater than nadir PSA + 2 ng/ml	5 year
Secondary	Biopsy Positive Rate	Patients were biopsied at 3 years post treatment	3 year