Health TrialsbyHealthPanel

Consolidative Prostate Radiotherapy in Metastatic Prostate Cancer

ConditionProstate Metastases
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-100
SponsorUniversity Health Network, Toronto

About this trial

This is a prospective, randomized phase II trial investigating if radiation treatment delivered every other day for 2 weeks has the same side effects as radiation treatment delivered once weekly for 6 weeks.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically-proven prostate cancer

Presence of low-volume or high-volume metastases (high volume defined as the presence of visceral metastases or ≥4 bone lesions with at least 1 lesion beyond the vertebral bodies and pelvis.)

Planned to or receiving systemic treatment ADT +/- ARAT as per physician discretion (Previous chemotherapy allowed if completed more than 6 weeks prior to randomization.)

Planned for EBRT

Disqualifiers

Prior radiotherapy to pelvis

Active ulcerative colitis or Crohn's Disease, at discretion of treating physician

Any condition where radiotherapy is contraindicated

Trial design

Design model

Parallel

Treatments tested in this trial

  • Radiotherapy

    Radiation

    Standard of care radiotherapy administered as per institutional guidelines.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Arm 1 - InvestigationalExperimental treatment 1 intervention
Group B: Arm 2 - StandardOther 1 intervention

Trial outcomes

Primary outcomes

1

Rates of acute toxicity

Compare rates of acute toxicity between participants in Arm 1 and Arm 2. Acute toxicity will be measured using CTCAE V5.0

Time frame
5 years

Secondary outcomes

1

Rates of late toxicity.

Compare rates of late toxicity between participants in Arm 1 and Arm 2. Late toxicity will be measured using CTCAE V5.0

Time frame
5 years
2

Measure failure-free survival

Compare failure-free survival, collected through medical records, for participants in Arm 1 and Arm 2

Time frame
5 years
3

Quality of Life Outcomes

EPIC-26 Questionnaire

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Health Network, Toronto

Lead sponsor

TerSera Therapeutics LLC

Collaborator

Source ClinicalTrials.gov
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