Management of Castration-Resistant Prostate Cancer with Oligometastases

Summary

This adaptive phase II/III randomized trial is designed to demonstrate that eradication of oligometastases by SBRT is a promising and emerging way to delay disease progression and postpone second line systemic therapies in castration-resistant prostate cancer (CRPC) patients. Only CRPC patients with an oligometastatic recurrence will be eligible to take part in this trial. All participating patients will receive either the standard of care (i.e. LHRH agonist in combination with the new generation of hormonal therapy \[Enzalutamide\]) or the experimental treatment (i.e. LHRH agonist in combination with the new generation of HT \[Enzalutamide\] plus the additional SBRT treatment). The patients will undergo different evaluations before treatment, such as imaging to confirm oligometastatic recurrence and blood tests. Patients will be stratified according to the location of metastasis (visceral \[with or without bone metastases\] vs. bone metastases alone) and PSA doubling time (≤ 3 vs. \> 3 months). As per the standard of care, patients will have PSA testing performed every 6-12 weeks and re-imaging at 6, 9, 12, 18 and 24 months or at PSA progression, whichever occurs first.

Conditions

• Castration-resistant Prostate Cancer Patients with Oligometastases

Interventions

DRUG

Leuprolide Acetate

Luteinizing hormone releasing hormone (LHRH) agonist administered by subcutaneous injection. Only one of the LHRH agonists described here will be administered during the course of treatment.

DRUG

Goserelin Acetate

Luteinizing hormone releasing hormone (LHRH) agonist administered by subcutaneous injection. Only one of the LHRH agonists described here will be administered during the course of treatment.

DRUG

Triptorelin

Luteinizing hormone releasing hormone (LHRH) agonist administered by subcutaneous injection. Only one of the LHRH agonists described here will be administered during the course of treatment.

DRUG

Enzalutamide

Anti-androgen medication for the treatment of metastatic castration-resistant prostate cancer. 160 mg (four 40 mg capsules) taken as a single oral daily dose, with or without food, until disease progression.

RADIATION

Stereotactic Body Radiation Therapy

Stereotactic body radiation therapy (SBRT) is a treatment modality in radiation oncology that delivers a very high dose of radiation to the tumour target with high precision using a single or a small number of fractions.

Sponsors & Collaborators

• Sir Mortimer B. Davis - Jewish General Hospital

  lead OTHER

Principal Investigators

• Tamim Niazi, MD · Jewish General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-10-31

Primary Completion

2027-04-30

Completion

2041-08-31

Countries

• Canada

Study Locations