FOcal Radiation for Oligometastatic Castration-rEsistant Prostate Cancer (FORCE)
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/22/2018 |
| Start Date: | August 14, 2018 |
| End Date: | September 1, 2023 |
| Contact: | Zachery Reichert, MD, PhD |
| Email: | zreiche@med.umich.edu |
| Phone: | (734)-764-3066 |
FOcal Radiation for Oligometastatic Castration-rEsistant Prostate Cancer (FORCE): A Phase II Randomized Trial
This clinical trial will determine whether the addition of radiotherapy to standard of care
first line systemic therapy improves objective progression-free survival rate (combined
radiographic and clinical) at 18 months, compared to first line systemic therapy alone.
first line systemic therapy improves objective progression-free survival rate (combined
radiographic and clinical) at 18 months, compared to first line systemic therapy alone.
Inclusion Criteria:
- Subjects must have biopsy-confirmed adenocarcinoma of the prostate
- Patients must discontinue all systemic or experimental therapies for at least 2 weeks
prior to registration with no evidence of a falling PSA (prostate specific antigen)
after washout. LHRH (luteinizing hormone-releasing hormone) analogues must be
continued if they have not undergone orchiectomy.
- Subjects must have progressive metastatic castration-resistant prostate cancer based
on at least one of the following criteria while having castrate levels (<50 ng/dL) of
testosterone:
- A) PSA progression defined as a 25% increase over baseline value with an increase in
the absolute value of at least 2.0 ng/mL that is confirmed by another PSA level with a
minimum of a 1-week interval.
- B) Progression of bidimensionally measurable soft tissue or nodal metastasis by CT
scan or MRI based on RECIST criteria
- C) Progression of bone disease on bone scan as defined by two new lesions arising
- Subjects must have oligometastatic prostate cancer, defined as between 1 and ≤5
treatment sites that can be treated within a radiotherapy treatment field.
- Subjects must be medically fit to undergo radiotherapy and first line systemic therapy
as determined by the treating physician.
- Age ≥ 18
- ECOG ≤ 2 (Eastern Cooperative Oncology Group scoring system used to quantify general
well-being and activities of daily life; scores range from 0 to 5 where 0 represents
perfect health and 5 represents death)
- No prior invasive malignancy in the past 3-years unless disease free for a minimum of
2 years. Exceptions include non-melanomatous skin cancer and in situ cancers of the
bladder or head and neck are permissible.
- Subjects must freely sign informed consent to enroll in the study.
Exclusion Criteria:
- Planned first line systemic therapy with Radium-223 dichloride or sipuleucel-T
- Life expectancy estimate of <3 months
- Presence of known parenchymal brain metastasis
- Uncontrolled intercurrent illness
- Inability to undergo radiotherapy, systemic treatment, CTs or bone scans
- Biopsy proven pure small cell or neuroendocrine prostate cancer
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