The SPARC Trial: Stereotactic Prostate Ablative Radiotherapy Using Cyberknife

Royal Marsden NHS Foundation Trust

Status and phase: Unknown; Phase 2

Conditions: Prostate Cancer

Treatments: Radiation: Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02145494

13/LO/0109

CCR 3923 (Other Identifier)

Details and patient eligibility

About

Giving a higher dose of radiation to the dominant tumour nodule within the prostate is hypothesized to improve tumour control. This trial will assess whether this technique, delivered in 5 treatments, can be delivered without increasing side effects.

Full description

Aim To assess if a focal boost can be delivered to the dominant tumour nodule alongside 36.25 Gy in 5 fractions to the whole prostate gland.

Primary end-point: Acute toxicity (Radiation Therapy Oncology Group (RTOG), International prostate symptom score (IPSS))

Secondary end-points: Prostate specific antigen (PSA) nadir and 2-year biochemical control Late toxicity (IPSS, RTOG, International index of erectile function (IIEF-5)) Quality of life (EQ5D scale)

Inclusion criteria

• Prostate cancer patients with any of the following:
• PSA>20
• Gleason grade 4+3 or higher
• Stage T3a
• Exclusion criteria
• Nodal or metastatic disease
• PSA>40
• Stage T3b or higher

Study interventions

This is a phase II study which will recruit 20 patients. A dose of 36.25 Gy in 5 fractions will be delivered to the whole prostate with a simultaneous integrated boost up to 47.5 Gy in 5 fractions or to the highest dose possible within dose constraints. The boost volume will be defined on the multiparametric magnetic resonance scan by the specialist radiologist.

Enrollment: 20 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion criteria

Prostate cancer patients with any of the following:

• PSA 20-40
• Gleason grade 4+3 or higher
• Stage T3a

Exclusion criteria

• Nodal or metastatic disease
• PSA>40
• Stage T3b or higher

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Treatment

Experimental group

Description:

Radiotherapy

Treatment:

Radiation: Radiotherapy