Health TrialsbyHealthPanel

Phase Ib Trial of 177Lu-PSMA-I&T Therapy in Combination With Olaparib and Pembrolizumab in Patients With Metastatic Castration Resistant Prostate Cancer

ConditionMetastatic Castrate Resistant Prostate Cancer (mCRPC)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorPeter MacCallum Cancer Centre, Australia

About this trial

This phase 1b trial is designed to evaluate the safety and tolerability of olaparib in combination with 177Lutetium-Prostate Specific Membrane Antigen (177 Lu-PSMA) and pembrolizumab in patients with metastatic castration resistant prostate cancer (mCRPC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient must have provided written informed consent using the LumOnate Patient Information and Consent Form (PICF)

Patient must be ≥ 18 years of age at Screening

Willing and able to comply with treatment schedule, laboratory testing, and other requirements of the study

Histologically confirmed adenocarcinoma of the prostate without neuroendocrine or small cell differentiation

Disqualifiers

Prior chemotherapy for mCRPC. Prior docetaxel is permitted if given in the setting of hormone sensitive disease

Site(s) of disease that are FDG positive with low PSMA expression defined by PSMA SUVmax < 10

Extensive marrow disease defined by a "Super Scan" on bone scintigraphy or diffuse marrow infiltration on PSMA PET

Active brain metastases or leptomeningeal metastases

Trial design

Design model

Single group

Treatments tested in this trial

  • Olaparib (300 mg BID)

    Drug

    oral tablet

  • Pembrolizumab

    Drug

    IV infusion

  • 177Lu-PSMA-I&T

    Radiation

    PSMA-I\&T is a small molecule ligand that binds to the extra-cellular domain of the prostatespecific membrane antigen. PSMA-I\&T is a small molecule ligand that binds to the extra-cellular domain of the prostatespecific membrane antigen

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: 177Lu-PSMA + olaparib + pembrolizumabExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Progression Free Survival

To describe the radiological progression free survival (modified RECIST 1.1 and/or PCWG3 criteria) of the combination of 177Lu-PSMA-I\&T, olaparib and pembrolizumab

Time frame
24 months from recruitment of last patient
2

Safety of Combination Therapy

To evaluate the safety of 177Lu-PSMA-I\&T in combination with olaparib and pembrolizumab. All adverse events (AE's) will be reported using CTCAE 5.0, with the severity (grade) and causality (relationship to investigational products) recorded for each participant.

Time frame
24 months from recruitment of last patient

Secondary outcomes

1

PSA50 response rate

To evaluate the PSA50 response rate

Time frame
24 months from recruitment of last patient
2

PSA90 response rate

To evaluate the PSA90 response rate

Time frame
24 months from recruitment of last patient
3

PSA progression free survival

To evaluate PSA progression free survival

Time frame
24 months from recruitment of last patient
4

Overall Survival

To evaluate the overall survival

Time frame
24 months from recruitment of last patient

Other outcomes

Sponsors and contacts

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

Peter MacCallum Cancer Centre, Australia

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: